583 Amendments of Laura BALLARÍN CEREZA
Amendment 1 #
2023/2115(INI)
Motion for a resolution
Citation 21 a (new)
Citation 21 a (new)
– having regard to the Eurofound's last esurvey, Living and Working in Europe, of Spring 2023,
Amendment 2 #
2023/2115(INI)
Motion for a resolution
Citation 21 b (new)
Citation 21 b (new)
– having regard the research from the World Economic Forum of 20231a, _________________ 1a https://www.weforum.org/agenda/2023/01 /cost-of-living-crisis-women-gender-gap/
Amendment 12 #
2023/2115(INI)
Motion for a resolution
Recital A
Recital A
A. whereas, since 2021, inflation has increased sharply, driven primarily by high energy and food costs, and exacerbated by the unjustified war of aggression against Ukraine; whereas wages are not projected to increase as fast as inflation, thus creating a cost of living crisis; whereas this crisis acutely threatens women’s livelihoods, health, well-being and access to housing, while limiting their purchasing power and ability to provide food, as well as decent standard of living;
Amendment 13 #
2023/2115(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas crises and energy poverty disproportionately affect women due to structural inequalities related to income distribution, including lower levels of savings and wealth and more debt, as well as lack of social security and public services; whereas women are over- represented in low paying sectors and more likely to work in public services, rely on public services, and become the providers of last resort when public services are withdrawn, due to disproportionate burden of unpaid care work; whereas the impact of high inflation and energy costs is leaving public services with few options; 1a _________________ 1a https://wbg.org.uk/wp- content/uploads/2022/03/The-gendered- impact-of-the-cost-of-living-crisis.pdf
Amendment 33 #
2023/2115(INI)
Motion for a resolution
Recital C
Recital C
C. whereas women in all their diversity are disproportionately affected by the consequences of the cost of living crisis, as they tend to be among the poorest part of the population, are highly represented in precarious jobs, have lower incomes as a result of the pay and pension gaps, and are still expected to carry out the bulk amongst temporary or part-time workers or informal jobs, overrepresented among minimum wage workers, have lower incomes as a result of the pay and pension gaps, are more likely to report difficulties in making ends meet (particularly if they work in blue collar occupations or are working single mothers) and still bear a disproportionate burden of unpaid care work, leaving them with fewer resources to protect themselves against the negative impact of the crisis;
Amendment 50 #
2023/2115(INI)
Motion for a resolution
Recital F
Recital F
F. whereas women, particularly single parents and those experiencing intersectional discrimination on grounds of ethnicity, race, migration status, sexual orientation, disability or age, are more likely to fall into energy poverty; whereas this means that the ongoing cost of living crisis will exacerbate gendered energy poverty in the EU; whereas gender disaggregated data are needed; where, according the UN, we are facing the largest cost of living crisis for a generation;
Amendment 55 #
2023/2115(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas according to Eurofound’s reporting on minimum wages, the high increases in nominal wage rates in many countries for 2023 was in many cases not enough to maintain workers’ purchasing power; whereas women are overrepresented among minimum wage workers;
Amendment 93 #
2023/2115(INI)
Motion for a resolution
Subheading 1 a (new)
Subheading 1 a (new)
Gender sensitive solutions to the rising cost of living
Amendment 94 #
2023/2115(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1 Recalls on the Commission to develop an ambitious 2030 European anti-poverty strategy, including time poverty, with concrete targets for reducing poverty and a focus on ending women’s poverty and breaking the intergenerational cycle of poverty risks;
Amendment 101 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Calls on the Union to promote an extraordinary package to support people struggling with skyrocketing costs of living, including €100 billion for families, especially the ones with single persons with dependant children -which the vast majority are mothers- most affected by energy poverty and at least €20 billion to sted up European Child Guarantee scheme;
Amendment 105 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Points out that an EU’s fiscal capacity requires a revision of the current economic and social governance, an adequate harmonised EU fiscal policy, including the extension of the clause allowing the maximum flexibility of the fiscal rules and the exemption of targeted measures related to the energy crisis from the calculation of the deficit within the fiscal rules;
Amendment 109 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Calls for an extension of the solidarity contribution required only from energy sector to all sectors benefiting from windfall profits and at least to banking, food distribution and pharmaceutical sectors;
Amendment 111 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 d (new)
Paragraph 1 d (new)
1d. Calls on the Member States to take gender sensitive approach when reforming pension systems and adapting the retirement age, taking into account women’s underrepresentation in the labour market, as well as labour market segregation and gender based discrimination;
Amendment 112 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 e (new)
Paragraph 1 e (new)
1e. Calls to ensure an adequate minimum income, following the European recommendations of a minimum income scheme above the poverty line and with a wiew to promote gender equality, income security and economic independence of women;
Amendment 113 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 f (new)
Paragraph 1 f (new)
1f. Recalls for fair and adequate minimum wages in the Member States as a necessary safeguard to ensure fairer wage distribution and to guarantee a basic wage floor protecting women according to the new European law;
Amendment 114 #
2023/2115(INI)
Motion for a resolution
Paragraph 1 g (new)
Paragraph 1 g (new)
1g. Calls on the Commission and the Member States to mainstream gender equality into all policies in order to achieve the best response to energy crisis, which disproportionately affects women, taking into account that the impact of high inflation and energy costs are undermining public services, in which women are more likely to work, to rely on and to replace when these public services are cancelled;
Amendment 117 #
2023/2115(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Calls for the Member States and the EU to urgently guarantee affordable utilities and food for low-income households such as single mothers households and, in particular, for those facing intersectional discrimination; stresses that no one should have to freeze in the height of winter or overheat in the scorching summer months and calls for the Member States and the EU to ban energy disconnections;
Amendment 131 #
2023/2115(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Member States to increase public investment in policies that, directly or indirectly, aim to counteract the negative effects of the cost of living crisis on women in all their diversity, to guarantee access to high-quality public services for care, education, health, including sexual and reproductive health and rights, and housing, to the decent employment and to protect victims of gender-based violence;
Amendment 155 #
2023/2115(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Highlights that access to electricity plays a fundamental role in poverty reduction and in ensuring full and equal participation in society; calls for the EU and the Member States to recognise the right to affordable energy;
Amendment 184 #
2023/2115(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recalls that thea just green transition is necessary to avoid severe future crises and increased poverty; recalls, furthermore, that the green transition will only be socially fair if it includes a gender perspective and guarantees equal opportunities for women and those experiencing intersectional discrimination; calls, therefore, on the Commission to appoint an EU gender and climate coordinator with sufficient staff and funding, and to introduce gender impact assessments in all EU policies and legislation, in particular in European Green Deal initiatives;
Amendment 5 #
2023/2043(INI)
Motion for a resolution
Citation 13 a (new)
Citation 13 a (new)
– having regard to Article 24 of the EU Charter of Fundamental Rights and the United Nations Convention on the Rights of the Child as elaborated in the UNCRC General Comment No. 25 as regards the digital environment,
Amendment 6 #
2023/2043(INI)
Motion for a resolution
Recital A
Recital A
A. whereas in today’s attention-based economy, technology companies use design and system functionalities to take advantage of users’ and consumers' vulnerabilities in order to capture their attention and increase the amount of time they spend on digital platforms; whereas many digital services, such as online games, social media, streaming services for films, series or music, online marketplaces or web shops and dating apps are designed to keep users on the platform for as long as possible so as to maximise the data collected and the time and money they spend there; whereas consequently many online services are designed to be as addictive as possible; whereas the terms ‘manipulative design’, ‘addictive design’ or ‘behavioural design’ of online services describe features that lead to behaviour- related risks and harms, including forms of digital addiction, such as, ‘excessive or harmful internet use’, ‘smartphone addiction’, ‘technological or internet addiction’, ‘social media addiction’; whereas there is a growing consensus among academics that phenomena, such as ‘social media addiction’ exist;
Amendment 11 #
2023/2043(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas with all the improvements that technology has brought into the lives of individuals, sophisticated use of data and AI technologies and the continuous exposure to monetisation-driven algorithms have already been seen to have harmful consequences affecting consumers’ online behaviour, exposing their ever-weaker position and reducing consumers and citizens’ trust in markets and democratic societies; whereas social media platforms must take steps to give back autonomy to the users, respecting their wellbeing regardless of profitability considerations, and give regulators and researchers the necessary tools to analyse the effects of using these platforms;
Amendment 15 #
2023/2043(INI)
B. whereas 16-24 year-olds spend an average of over seven hours a day on the internet; whereas one in four children and young people display ‘problematic’ or ‘dysfunctional’ smartphone use, meaning behavioural patterns mirroring addiction; whereas research suggests that problematic smartphone use continues to rise; whereas research also suggests that the rise in mental health problems in adolescents might be related to excessive social media u and that many children rarely disconnect from social media and use it constantly throughout the day feeling insecure without their mobile phone; whereas research also suggests that the rise in mental health problems in adolescents might be related to excessive social media use and that social media pressure has been identified as one of the top five causes of mental health difficulties for children; whereas younger populations are more vulnerable to psychopathological developments, and harmful behaviours and mental health conditions established in childhood can shape the subsequent life course;
Amendment 21 #
2023/2043(INI)
Motion for a resolution
Recital C
Recital C
C. whereas internet-use-related addiction displays similar side effects to substance-related addictions, including evidence of tolerance and relapse; whereas strict regulation exists for addictive products, such as drugs, alcohol, tobacco and gambling to prevent addiction and protect consumers from harm; whereas problematic smartphone or internet use has been linked to lower life satisfaction and mental health symptoms such as depression, low self-esteem, body-image disorders, eating disorders, anxiety, high levels of perceived stress, neglect of family and friends, loss of self-control, lack of sleep and obsessive-compulsive symptoms, such as compulsive buying among young adults; whereas heavy users of digital media are twice as likely to have mental- health issues, including risk factors for suicide and self-harm; whereas children and young people are more vulnerable to these symptoms; whereas mental-health conditions established in childhood can shape an individual’s subsequent life course; whereas excessive internet use is associated with problems with daily obligations, declining grades, poor school and academic performance or poor job performance; whereas the prevalence of digital addictions and its association with symptoms of common mental disorders is a growing public health problem and as such, it should be a concern to policy makers; whereas further research should develop a consensus regarding the most appropriate diagnostic criteria and determine risk factors for different digital addictions.
Amendment 23 #
2023/2043(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas all online services and products that are likely to be accessed by children should be designed with the best interests of the child as a primary consideration; whereas certain online addictive services and products can be highly risky, addictive, or otherwise harmful for children, including due to the combined impact of several features or their cumulative impact over time;
Amendment 29 #
2023/2043(INI)
Motion for a resolution
Recital E
Recital E
E. whereas addictive design can be seen to have a negative impact on everyone, not just individuals showing problematic usage patterns; whereas addictive design, especially of smartphones and social media, makes it hard to focus on the task in hand owing to distractions such as messages and notifications constantly disrupting peoples’ concentration, even at school or while driving; whereas the addictive design of online services leads to increased pressure to perform and social pressure to be permanently online and connected, increasing the risk of stress and burnout; whereas consumers online are increasingly confronted with an information overload and excessive sensorial stimuli throughout the day, constraining their cognitive ability, and user interfaces offer only limited control over their data; whereas the time people spend behind screens is time not spent being active, moving, being outside, or shutting down and relaxing, all of which are associated with physical and mental well-being and which are especially crucial for children’s development; whereas adolescents who spend a small amount of time on electronic communication are generally the happiest; whereas people that stop using social media for a week experience significant improvements in well-being;
Amendment 41 #
2023/2043(INI)
Motion for a resolution
Recital H
Recital H
H. whereas addictive design features are often linked to psychosocial patterns playing on consumers’ psychological needs, vulnerabilities and desires, such as social belonging, social anxiety, fear of missing out (encouraged by information being available only temporarily, such as ‘stories’, ‘is typing…’), network effects, the urge to finish tasks in a flow, even if interrupted (endless scrolling, taking a number of seconds to load yourflashes of high-relevance content that are immediately hidden as the newsfeed reloads) and loss of self-control; whereas design features can be addictive for different reasons, such as an intermittent variable reward, leading to a dopamine surge, just like the dynamics of slot machines, such as push notifications, or social reciprocity leading to chemical brain reactions, where on the one hand people receive social gratification, such as likes, and on the other hand people feel social pressure to respond to people, such as with read-receipts;
Amendment 42 #
2023/2043(INI)
Motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas modern-day data driven services place the consumer in a weaker position creating power imbalances and digital asymmetry resulting in a universal state of digital vulnerability that results from internal and external factors beyond the control of the consumer; whereas consumers are constantly facing AI that can easily detect and exploit their vulnerabilities and services regularly changing their choice architectures to maximise conversion rates and engagement; whereas this demonstrates that vulnerability must not be restricted to 'traditionally protected' groups but must include all consumers;
Amendment 54 #
2023/2043(INI)
Motion for a resolution
Recital K
Recital K
K. whereas the addictive design features outlined above cannot be solved simply by imposing time-limits on online services, as this approach shifts the burden onto the individual instead of addressing the core issue of the intentionally addictive design of online services for profit; whereas none of the ‘solutions’ platforms have implemented have led to a serious change or decrease in usage of online services; whereas teenagers do not readily accept parental regulation of their social media use and often find it easy to bypass any technical constraints imposed; whereas providers must have a direct responsibility to respect children’s rights in the digital environment through safety-by-design approaches, and ensuring that products and services are designed taking the best interest of the child and do not cause negative outcomes for children.
Amendment 56 #
2023/2043(INI)
Motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas the use of persuasive design strategies is linked to the prevalence of digital addiction and Very Large Online Platforms (VLOPs) often rely on persuasive design strategies to influence users and maximise the time they spend on the platform; whereas despite recent advances in European regulation of the digital sphere, existing legislation does not sufficiently address persuasive and addictive design practices.
Amendment 59 #
2023/2043(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the Digital Services Act (DSA) introduces provisions against the use of ‘dark patterns’ but these are limited to choice architecture and influences choices and do not address behavioural design that is addictive per se, moreover they are limited inwhile these provisions only apply to cases not covered by the General Data Protection Regulation and the Unfair Commercial Practices Directive, they are also limited scope as they only apply to online platforms, not to all online services; whereas the AI Act4 seeks to ban AI systems that deploy subliminal features but is limited to systems that ‘are purposefully manipulative or deploy deceptive techniques’; _________________ 4 Proposal for a regulation laying down harmonised rules on artificial intelligence (artificial intelligence act) (COM(2021)0206).
Amendment 65 #
2023/2043(INI)
Motion for a resolution
Recital L a (new)
Recital L a (new)
La. whereas the Digital Services Act (DSA) foresees more transparency for the main parameters of recommender systems, including the ability to modify or select the parameters of recommender systems; whereas Digital Services Act (DSA) introduces an obligation for Very Large Online Platforms (VLOPs) to provide users with at least one option of their recommender systems that is not based on profiling;
Amendment 66 #
2023/2043(INI)
Motion for a resolution
Recital L b (new)
Recital L b (new)
Lb. whereas the Digital Services Act (DSA) introduces an obligation for online platforms used by platforms to take appropriate and proportionate measures to protect minors, for example by designing their online interfaces or parts thereof with the highest level of privacy, safety and security for minors by default where appropriate or adopting standards for protection of minors, or participating in codes of conduct for protecting minors; whereas online platforms should not present advertisements on their interface based on profiling as defined in Article 4, point (4), of Regulation (EU) 2016/679 using personal data of the recipient of the service when they are aware with reasonable certainty that the recipient of the service is a minor;
Amendment 67 #
2023/2043(INI)
Motion for a resolution
Recital L c (new)
Recital L c (new)
Lc. whereas Very Large Online Platforms (VLOPs) and Very Large Online Search Engines (VLOSEs) have an obligation to conduct risk assessments under the Digital Services Act (DSA); whereas Very Large Online Platforms (VLOPs) and Very Large Online Search Engines (VLOSEs) should analyse how minors can be exposed through their service to content that may impair their health, physical, mental or moral development, taking into account risks that may arise, for example, in relation to the design of online interfaces which intentionally, or unintentionally exploit the weaknesses and inexperience of minors or which may cause addictive behaviour; whereas in the context of the broader concerns about the protection of children in the digital environment, there is a clear need to assess the aspects related to the commercial exploitation and the effects of commercial practices on children and young consumers;
Amendment 68 #
2023/2043(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Welcomes the European Commission's 'digital fairness' fitness check of consumer law, as a unique opportunity to pave the way for a new generation of consumer protection legislation that will reverse the negative trends, which have been weakening consumers’ position and reducing consumers’ rights in a world dominated by digital technologies; to this end, calls on the European Commission for its fitness check to review the concepts and definitions in consumer law such as definition of “consumer”, “vulnerable consumer” and “trader” in order to protect consumers from harms and respond to the challenges brought about by the age of data;
Amendment 69 #
2023/2043(INI)
Motion for a resolution
Paragraph -1 a (new)
Paragraph -1 a (new)
-1a. Believes that digital addiction and persuasive technologies are problems that require a comprehensive regulatory response from the EU, with a series of supportive policy initiatives, to meaningfully address digital addiction and empower citizens with the ability to determine how they use digital service and products to further their own goals and be protected against new forms of addiction and problematic uses of the internet;
Amendment 74 #
2023/2043(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that despite its legislative efforts in the digital field, such as the Digital Services Act (DSA) or the AI Act, the issue of addictive design is not sufficiently covered in existing EU legislation, and if unaddressed could lead to further deterioration in the area of public health, especially affecting minors; considers that if the topic gets further delayed, Parliament should use its right of legislative initiative; calls on the Commission to ensure robust enforcement of all existing legislation on the matter with the highest possible degree of transparency, notably the General Data Protection Regulation (GDPR) and the Digital Services Act (DSA);
Amendment 84 #
2023/2043(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Commission to present legislation against addictive design; urges the Commission in its review of the Unfair Commercial Practices Directive5 (UCPD), Consumer Rights Directive6 and Unfair Contract Terms Directive7 (Fitness check) to pay particular attention to and tackle the growing issues around the addictive, behavioural and manipulative design of online services; _________________ 5 Directive 2005/29/EC of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (OJ L 149, 11.6.2005, p. 22). 6 Directive 2011/83/EU of 25 October 2011 on consumer rights (OJ L 304, 22.11.2011, p. 64). 7 Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).
Amendment 85 #
2023/2043(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Is of the opinion that the Unfair Commercial Practices Directive (UCPD) should integrate the concept of digital asymmetry and recognise that consumer digital vulnerability is the universal state of susceptibility and ensure that the definition of 'transactional decision' in the UCPD includes transactions where the behaviour of the consumer is connected to the revenue-earning model of the trader to captures services which monetise the attention and engagement of consumers, where the consumer pays the trader by spending their time and interacting with the service;
Amendment 86 #
2023/2043(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Reiterates that horizontal consumer law must respond to the fact that digital asymmetry also affects enforcers and to this end strengthening the institutional pillars of cross-border consumer law enforcement focusing on the review and improvements to the regime governed by the Consumer Protection Cooperation Regulation is needed;
Amendment 97 #
2023/2043(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Demands that a revision of the Unfair Commercial Practices Directive should take into account consumers’ susceptibility to the exploitation of the unequal power in the trader-consumer relationship resulting from internal and external factors beyond the consumer’s control; stresses that the autonomy of consumers should not be undermined by traders’ commercial practices, in particular the design and operation of the interface, to this end is of the opinion that Unfair Commercial Practices Directive (UCPD) should also mandate the reversal of the burden of proof placed on the trader to demonstrate compliance in cases of power asymmetries and a duty of care on the part of the trader to ensure a high level of consumer protection and a horizontal principle of fairness by design of digital products and services;
Amendment 104 #
2023/2043(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Believes that consumers should be granted the right to meaningful personalisation that would afford them effective control over the recommendations they are shown by content recommender systems and the right to receive non-personalised offers, and to receive only such product and service offers and content recommendations which are not based on algorithmic personalisation techniques;
Amendment 106 #
2023/2043(INI)
Motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Believes that any response at the EU level should aim to create meaningful consultation, cooperation, and collaboration with and between stakeholders, particularly lawmakers, public health bodies, and media regulators, companies, consumer organisations and NGOs; Stresses that stakeholders must work collaboratively to develop, assess and take regulative actions to prevent and minimize the harm associated with problematic online behaviours; Furthermore, believes that the broad use of educational guidelines and prevention plans, as well as awareness-raising campaigns, should promote self-control strategies to help individuals develop safer online behaviours and new healthy habits;
Amendment 115 #
2023/2043(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Strongly believes that providers should move away from platform features that encourage a focus on monopolising users’ attention, including personalised advertising and continuous streams of content to help users autonomously choose what content they wish to engage with, and limit the ability of social media platforms; support developing, implementing and evaluating in-app functions that might support users’ self- control, such as warning messages or developing, implementing, and evaluating awareness campaigns concerning potential risks resulting from problematic online behaviours;
Amendment 116 #
2023/2043(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the significant impact of addictive design on children and youngsters and calls on the Commission to make additional international efforts to regulate addictive design online in this regard; and the need to develop and implement regulatory instruments and industry standards on safety by design digital services and products for children which can foster compliance with children’s rights;
Amendment 2 #
2023/0373(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) MAs micro, small and medium-sized enterprises (SMEs) inaccount for an important share of the pellet supply chain, they should comply with the relevant obligations laid down in this Regulation, however they could face proportionally higher costs and difficulties when complying with some of the obligations. The Commissionwhile taking into consideration the possible different challenges in compliance and the possible proportionally higher costs. The Commission and the competent authorities should raise awareness among economic operators and carriers regarding the necessity of preventing pellet losses. Additionally, the Commission and the competent authorities should develop training materials to assist them in fulfilling their obligations, particularly with respect to the requirements of the risk assessment. Member States should provide access to information and assistance regarding compliance with obligations and the risk assessment requirements. Regarding the assistance of Member States, this could include technical and financial support as well as specialised training to to all personnel handling pellets in the SMEs. Member States actions should be taken in respect of applicable State aid rules.
Amendment 6 #
2023/0373(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The CommissionBy 6 months after the entry into force of this Regulation the Commission and the competent authorities shall develop awareness raising and training material on the sound implementation of the obligations laid down in this Regulation. This shall be done based on the non-binding Recommendation adopted by the parties to the Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR) in consultation with representatives of economic operators, carriers, and certifiers, including micro, small and medium-sized enterprises and in collaboration with competent authoritie, social partners, civil society representatives and non-governmental organisations.
Amendment 13 #
2023/0373(COD)
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 2 – point a
Article 12 – paragraph 2 – subparagraph 2 – point a
(a) financial support including through fiscal incentives;
Amendment 16 #
2023/0373(COD)
Proposal for a regulation
Article 12 – paragraph 3
Article 12 – paragraph 3
3. Member States shall strongly encourage training programmes for the qualification of certifiers’ personnel.
Amendment 44 #
2023/0323(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Late payment constitutes a breach of contract which is financially attractive to debtors, due to low or no interest rates charged on late payment, or slow procedures for redress. A decisive shift to a culture of prompt payment, including one in which the exclusion of the right to charge interest for late payment is null and void, is necessary to reverse this trend and to discourage late payment. Consequently, contractual payment periods should be limited to 30 calendarworking days both in B2B transactions and G2B transactions, where the public authority is the debtor. Electronic invoicing can be a helpful tool in this regard, as it would help creditors prove the date of receipt of the invoice in case of doubt or dispute.
Amendment 44 #
2023/0323(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Late payment constitutes a breach of contract which is financially attractive to debtors, due to low or no interest rates charged on late payment, or slow procedures for redress. A decisive shift to a culture of prompt payment, including one in which the exclusion of the right to charge interest for late payment is null and void, is necessary to reverse this trend and to discourage late payment. Consequently, contractual payment periods should be limited to 30 calendarworking days both in B2B transactions and G2B transactions, where the public authority is the debtor. Electronic invoicing can be a helpful tool in this regard, as it would help creditors prove the date of receipt of the invoice in case of doubt or dispute.
Amendment 50 #
2023/0323(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) Public authorities in particular should set an example of due payments for the rest of economic actors.
Amendment 50 #
2023/0323(COD)
Proposal for a regulation
Recital 11 a (new)
Recital 11 a (new)
(11a) Public authorities in particular should set an example of due payments for the rest of economic actors.
Amendment 53 #
2023/0323(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The procedures of acceptance or verification for ascertaining the conformity of the goods or services provided with the requirements of the contract, as well as verification of the correctness and conformity of the invoice, are often used to delay intentionally the payment period. Their inclusion in the contract should therefore be objectively justified by the particular nature of the contract in question or by certain of its characteristics43 . It should therefore be possible to provide for such procedure of verification or acceptance in a contract only when provided for in national law where necessary, due to the specific nature of the goods or services. To avoid that the procedure of acceptance or verification is used to extend the payment period, the contract should clearly describe the details of such procedure, including its duration. For the same purpose, the debtor should initiate the verification or acceptance procedure immediately upon reception from the creditor of the goods and/or the services that are the object of the commercial transaction, regardless of whether the creditor has issued an invoice or equivalent request for payment. In those cases where the date of receipt of the invoice is difficult to prove by one of the parties, the debtor shall make the payment for the goods or services within 30 days upon reception from the creditor of the goods and/or services that are object of the commercial transaction. In order not to jeopardise the achievement of the objectives of this Regulation, it is appropriate to set a maximum duration of a procedure of acceptance or verification. __________________ 43 Judgment of 20 October 2022, BFF Finance Iberia SAU v Gerencia Regional de Salud de la Junta de Castilla y León (OJ C 53, 15.2.2021, p. 19) C585/20, EU:C:2022:806, paragraph 53.
Amendment 53 #
2023/0323(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The procedures of acceptance or verification for ascertaining the conformity of the goods or services provided with the requirements of the contract, as well as verification of the correctness and conformity of the invoice, are often used to delay intentionally the payment period. Their inclusion in the contract should therefore be objectively justified by the particular nature of the contract in question or by certain of its characteristics43 . It should therefore be possible to provide for such procedure of verification or acceptance in a contract only when provided for in national law where necessary, due to the specific nature of the goods or services. To avoid that the procedure of acceptance or verification is used to extend the payment period, the contract should clearly describe the details of such procedure, including its duration. For the same purpose, the debtor should initiate the verification or acceptance procedure immediately upon reception from the creditor of the goods and/or the services that are the object of the commercial transaction, regardless of whether the creditor has issued an invoice or equivalent request for payment. In those cases where the date of receipt of the invoice is difficult to prove by one of the parties, the debtor shall make the payment for the goods or services within 30 days upon reception from the creditor of the goods and/or services that are object of the commercial transaction. In order not to jeopardise the achievement of the objectives of this Regulation, it is appropriate to set a maximum duration of a procedure of acceptance or verification. __________________ 43 Judgment of 20 October 2022, BFF Finance Iberia SAU v Gerencia Regional de Salud de la Junta de Castilla y León (OJ C 53, 15.2.2021, p. 19) C585/20, EU:C:2022:806, paragraph 53.
Amendment 63 #
2023/0323(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Public procurement can play a significant role in improving payment performance. Enhanced synergies should therefore be put in place between public procurement policies and rules and prompt payment objectives. Particularly introducing effective measures to discourage not only late payment by public authorities, but also the awarding of contracts to companies that do not pay on time and in the manner prescribed by this Regulation. Furthermore, in public construction works, subcontractors are often not paid on time by the main contractor, even when the contracting authorities or contracting entities have made the contractual payments to them, thus potentially creating a damaging domino-effect in the supply chain. It is therefore appropriate that contractors provide evidence to contracting authorities and contracting entities of payments to their direct subcontractors.
Amendment 63 #
2023/0323(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Public procurement can play a significant role in improving payment performance. Enhanced synergies should therefore be put in place between public procurement policies and rules and prompt payment objectives. Particularly introducing effective measures to discourage not only late payment by public authorities, but also the awarding of contracts to companies that do not pay on time and in the manner prescribed by this Regulation. Furthermore, in public construction works, subcontractors are often not paid on time by the main contractor, even when the contracting authorities or contracting entities have made the contractual payments to them, thus potentially creating a damaging domino-effect in the supply chain. It is therefore appropriate that contractors provide evidence to contracting authorities and contracting entities of payments to their direct subcontractors.
Amendment 71 #
2023/0323(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) To guarantee full payment of the amount due, it is important to ensure thatretention of title can be agreed for specific goods such as slow moving or seasonal goods. In such agreements, the seller retains the title to goods until they are fully paid for, if a retention of title has been expressly agreed between the buyer and the seller before the delivery of the goods.
Amendment 71 #
2023/0323(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) To guarantee full payment of the amount due, it is important to ensure thatretention of title can be agreed for specific goods such as slow moving or seasonal goods. In such agreements, the seller retains the title to goods until they are fully paid for, if a retention of title has been expressly agreed between the buyer and the seller before the delivery of the goods.
Amendment 99 #
2023/0323(COD)
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. This Regulation shall not apply to consignment agreements.
Amendment 99 #
2023/0323(COD)
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1a. This Regulation shall not apply to consignment agreements.
Amendment 120 #
2023/0323(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘late payment’ means payment not made within the contractual or statutory payment period as set out in Article 3 or a delay as set out in Article 5(1);
Amendment 120 #
2023/0323(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘late payment’ means payment not made within the contractual or statutory payment period as set out in Article 3 or a delay as set out in Article 5(1);
Amendment 131 #
2023/0323(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
Article 2 – paragraph 1 – point 9 a (new)
(9a) ‘means of payment’ means the instrument used to settle the invoice, which will not entail a cost to the creditor as set out in Article 3(2).
Amendment 131 #
2023/0323(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
Article 2 – paragraph 1 – point 9 a (new)
(9a) ‘means of payment’ means the instrument used to settle the invoice, which will not entail a cost to the creditor as set out in Article 3(2).
Amendment 146 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. In commercial transactions, the payment period shall not exceed 30 calendar days, from the date of the receipt of the invoice or an equivalent request for payment by the debtor, provided that the debtor has received the goods or services. Where the date of the receipt of the invoice or the equivalent request for payment is uncertain, the payment period shall be 30 calendar days after the date of receipt of the goods or services. This period shall apply both to the transactions between undertakings and between public authorities and undertakings. The same payment period shall also apply to the supply of non- perishable agricultural and food products on a regular and non-regular basis as referred to in Articles 3(1)(a), point (i), second indent and 3(1)(a), point (ii), second indent of Directive (EU) 2019/633, unless Member States provide for a shorter payment period for such products.
Amendment 146 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. In commercial transactions, the payment period shall not exceed 30 calendar days, from the date of the receipt of the invoice or an equivalent request for payment by the debtor, provided that the debtor has received the goods or services. Where the date of the receipt of the invoice or the equivalent request for payment is uncertain, the payment period shall be 30 calendar days after the date of receipt of the goods or services. This period shall apply both to the transactions between undertakings and between public authorities and undertakings. The same payment period shall also apply to the supply of non- perishable agricultural and food products on a regular and non-regular basis as referred to in Articles 3(1)(a), point (i), second indent and 3(1)(a), point (ii), second indent of Directive (EU) 2019/633, unless Member States provide for a shorter payment period for such products.
Amendment 163 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. Notwithstanding the rights and obligations conferred by this Regulation, the provisions of this Article shall not apply to contracts of consignment where a consignment contract refers to an agreement wherein a seller (consignor) entrusts goods to an individual or entity (consignee) for the purpose of selling them. The consignee, upon selling the goods, shall remit the agreed-upon price to the consignor, deducting an agreed-upon commission. Any unsold goods may be returned to the consignor, as stipulated in the consignment agreement. This exemption from this Regulation is specific to contracts of consignment and does not affect the applicability of other relevant laws or regulations.
Amendment 163 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. Notwithstanding the rights and obligations conferred by this Regulation, the provisions of this Article shall not apply to contracts of consignment where a consignment contract refers to an agreement wherein a seller (consignor) entrusts goods to an individual or entity (consignee) for the purpose of selling them. The consignee, upon selling the goods, shall remit the agreed-upon price to the consignor, deducting an agreed-upon commission. Any unsold goods may be returned to the consignor, as stipulated in the consignment agreement. This exemption from this Regulation is specific to contracts of consignment and does not affect the applicability of other relevant laws or regulations.
Amendment 167 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. No means of payment for goods or services shall be used to alter the payment period.
Amendment 167 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1a. No means of payment for goods or services shall be used to alter the payment period.
Amendment 176 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. A procedure of acceptance or verification may be exceptionally provided for in national law only where strictly necessary due to the specific nature of the goods or services. In that case, the contract shall describe the details of the procedure of acceptance or verification, including its duration.
Amendment 176 #
2023/0323(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. A procedure of acceptance or verification may be exceptionally provided for in national law only where strictly necessary due to the specific nature of the goods or services. In that case, the contract shall describe the details of the procedure of acceptance or verification, including its duration.
Amendment 213 #
2023/0323(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. For public works contracts falling within the scope of Directives 2014/23/EU, 2014/24/EU, 2014/25/EU, and 2009/81/EC56 of the European Parliament and of the Council, contractors shall provide evidence to contracting authorities or contracting entities within the meaning of those Directives that, where applicable, they have paid their direct subcontractors involved in the execution of the contract within the deadlines and under the conditions set out inset out in Article 3 of this Regulation. The evidence mayshall take the form of a written declaration, which will include a certificate stating the date of receipt of payment by the subcontractor and shall be provided by the contractor to the contracting authority or contracting entity prior to, or at the latest together with, any request for payment. __________________ 56 Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC.
Amendment 213 #
2023/0323(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. For public works contracts falling within the scope of Directives 2014/23/EU, 2014/24/EU, 2014/25/EU, and 2009/81/EC56 of the European Parliament and of the Council, contractors shall provide evidence to contracting authorities or contracting entities within the meaning of those Directives that, where applicable, they have paid their direct subcontractors involved in the execution of the contract within the deadlines and under the conditions set out inset out in Article 3 of this Regulation. The evidence mayshall take the form of a written declaration, which will include a certificate stating the date of receipt of payment by the subcontractor and shall be provided by the contractor to the contracting authority or contracting entity prior to, or at the latest together with, any request for payment. __________________ 56 Directive 2009/81/EC of the European Parliament and of the Council of 13 July 2009 on the coordination of procedures for the award of certain works contracts, supply contracts and service contracts by contracting authorities or entities in the fields of defence and security, and amending Directives 2004/17/EC and 2004/18/EC.
Amendment 265 #
2023/0323(COD)
Proposal for a regulation
Article 9 – paragraph 1 – introductory part
Article 9 – paragraph 1 – introductory part
1. The following contractual terms and practices shall be prohibited. Any such terms and practices shall be null and void:
Amendment 287 #
2023/0323(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
A creditoseller shall retain title to goods until they are fully paid for if a retention of title such as consignment agreements or deposit of goods has been expressly agreed between the debtobuyer and the creditoseller before the delivery of the goods. Pursuant to Article 1(5), contracts in which a retention of title has been expressly agreed are not subject to the payment terms established under Article 3 of this Regulation.
Amendment 305 #
2023/0323(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Each Member State shall designate one or more authorities responsible for the enforcement of this Regulation (‘enforcement authority’). Member States shall provide this authority with appropriate human, technical and financial resources to carry out its tasks and enforce its powers efficiently.
Amendment 325 #
2023/0323(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Enforcement authorities shall cooperate effectively with each other and with the Commission and shall provide each other with mutual assistance in investigations that have a cross-border dimension. The Commission shall oversee the effective cooperation of the enforcement authorities.
Amendment 330 #
2023/0323(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. Enforcement authorities shall coordinate their activities including through exchange of information with other authorities responsible for enforcing other Union or national legislation including through exchange of information obligationsas well as with those authorities responsible for the allocation of public funds, in order not to grant such funds to undertakings which are not in conformity with the payment terms set out in Article 3.
Amendment 359 #
2023/0323(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Creditors may address complaints either to the enforcement authority of the Member State in which they are established or to the enforcement authority of the Member States in which the debtor is established. The enforcement authority to which the complaint is addressed shall be competent to enforce this Regulation. The enforcement authority shall notify the creditor filing a complaint within 60 calendar days how it intends to follow up on the complaint.
Amendment 364 #
2023/0323(COD)
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. Where the complainant so requests, tThe enforcement authority shall take the necessary measures for the appropriate protection of the identity of the complainant. The complainant shall identify any information for which it requests confidentiality.
Amendment 372 #
2023/0323(COD)
Proposal for a regulation
Article 15 – paragraph 7 a (new)
Article 15 – paragraph 7 a (new)
7a. European Commission shall design, through an implementing act, a standard complaint form available in all EU languages that shall be available on the website or otherwise provided by the enforcement authority in every Member State.
Amendment 385 #
2023/0323(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Member States shall ensure that credit management tools, including factoring and financial literacy trainings are available and accessible to small and medium sized enterprises, including on the use of digital tools for timely payments.
Amendment 388 #
2023/0323(COD)
Proposal for a regulation
Article 17 a (new)
Article 17 a (new)
Article 17a European Observatory of late payment 1. The Commission shall set up an Observatory of Late Payment (The Observatory) by ... [OP: date of application of this Regulation]. 2. The Observatory shall monitor payment as well as late payment practices within the Union in order to collect and share expertise, best practices and identify potential harmful practices with a view to provide the Commission with advice and expertise on the evolution of payment and late payment practices. 3. The Observatory shall be able to issue opinions or written contributions related to the implementation of this Regulation. 4. The Observatory shall be chaired by the Commission and shall be composed of representatives of relevant experts and stakeholders. The composition of the board shall ensure a balanced representation of all interested stakeholders.
Amendment 392 #
2023/0323(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
By [OP: please insert the date = 43 years after the entry into force of this Regulation], the Commissionand 2 years thereafter, the Commission, with the input of the EU Payment Observatory, shall submit a report on the implementation of this Regulation to the European Parliament and the Council.
Amendment 78 #
2023/0290(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Children are a particularly vulnerable group. It isThe UN Convention on the Rights of the Child recognises the right of all children to have the best possible start in life, to grow up healthy, and to develop to their full potential. Such a right should be enjoyed by all children, without the risk of being exposed to harmful substances while using toys. It is therefore essential to ensure a high level of safety of children when playing with toys. Children should be adequately protected from possible risks stemming from toys, in particularsuch as those stemming from the chemical substances that toys may contain. At the same time, compliant toys should be able to move freely across the internal market without additional requirements.
Amendment 84 #
2023/0290(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Toys are also subject to Regulation (EU) 2023/988 on general product safety25 , which applies in a complementary manner in matters not covered by specific sectoral legislation on consumer products. In particular, Section 2 of Chapter III and Chapter IV in relation to online sales, Chapter VI on the Safety Gate Rapid Alert System and Safety Business Gateway and Chapter VIII on the right of information and remedy also apply to toys. Therefore, this Regulation does not include specific provisions on distance and online sales, accident reporting by economic operators and the right of information and remedy but rather requires economic operators providing information on safety issues concerning toys to inform authorities and consumers in accordance with the procedures set out in Regulation (EU) 2023/988. _________________ 25 OJ L 11, 15.1.2002, p. 4.
Amendment 94 #
2023/0290(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Essential safety requirements for toys should ensure protection from all relevant health and safety hazards posed by toys, for users or third parties. Particular safety requirements should cover the physical and mechanical properties, flammability, chemical properties, electrical properties, hygiene and radioactivity to ensure that the safety of children is adequately protected against those specific hazards. Since it is possible that toys which present hazards that are not covered by a particular safety requirement might exist or be developed, it is necessary to maintain a general requirement of safety to ensure protection of children in respect of such toys. The safety of toys should be determined by reference to the intended use, while taking into account also the foreseeable use and misuse, and bearing in mind the behaviour of children, who do not generally show the same degree of care as the average adult user. Together, the general safety requirement and the particular safety requirements should form the essential safety requirements for toys.
Amendment 100 #
2023/0290(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Relying on digital technologies has led to new hazards in toys. Radio toys are to comply with essential requirements for the protection of privacy and internet- connected toys are to incorporate safeguards towards cybersecurity and protection from fraud in accordance with Directive 2014/53/EU of the European Parliament and of the Council30 and Regulation [insert serial number for Regulation on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020]. Toys which include artificial intelligence as a safety component are to comply with Regulation (EU) …/…[P.O. insert serial number for Regulation laying down harmonised rules on artificial intelligence]31 . Therefore, particular safety requirements regarding cybersecurity, protection of personal data and privacy or other hazards stemming from the incorporation of artificial intelligence in toys should not be set out. However, protecting the health of children should not merely ensure the absence of disease or infirmity and relying on digital technologies may pose risks to children which go beyond their physical health. To ensure that children are protected from any risk coming from the use of digital technologies in toys, the general safety requirement should ensure the psychological and mental health, as well as the well-being and cognitive development, of children. _________________ 30 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62). 31 PO: Please insert in the text the number of the Regulation and insert the number, date, title and OJ reference of that Regulation in the footnote.
Amendment 106 #
2023/0290(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Toys should comply with physical and mechanical requirements that prevent children from getting physically injured when playing with toys and should not pose a risk of choking or suffocation to children. In order to protect children from the risk of impaired hearing, maximum values should be set out for both impulse noise and continuous noise emitted by toys. Toys or their parts and their packaging which can be reasonably expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use and misuse are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council32 . In addition, it is appropriate to lay down specific safety requirements to cover the potential specific hazard presented by toys in food, since the association of a toy and food could cause a risk of choking which is distinct from the risks presented by the toy alone and which is, therefore, not covered by any specific measure at Union level. Toys should also ensure sufficient protection as regards flammability or electric properties, in particular to prevent burns or electric shocks. Moreover, toys should meet certain hygiene standards to avoid microbiological risks or other risks of infection or contamination. _________________ 32 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Amendment 109 #
2023/0290(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The use of nickel in stainless steel and in components that transmit electric current has been considered safe in toys by the Scientific Committee on Health, Environment and Emerging risks and should be allowed. Other substances that are necessary to transmit electric current should be permitted in toys to allow for the making available of electric toys only if such substances are completely inaccessible for a child playing with the toy and therefore do not present aare presumed as not presenting a substantial risk.
Amendment 111 #
2023/0290(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Existing limit values for certain chemical substances and their corresponding test methods have proven to be appropriate for the protection of children as regards those substances and should be maintained. In order to adapt to new scientific knowledge, the Commission should be empowered to revise those limit values where necessary. Limit values for arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic and which should therefore not be intentionally used in toys, should be set out at half the values that are considered safe by the relevant scientific body, in order to ensure that only traces that are compatible with good manufacturing practice and with the health and safety of the child throughout his or her development are present in the toy.
Amendment 114 #
2023/0290(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) To prevent misuse of warnings to circumvent the applicable safety requirements, the warnings provided for certain categories of toy should not be allowed if they conflict with the intended use of the toy. To ensure that supervisors are aware of any risks associated with the toy, it is necessary to ensure that the warnings are legible and visibleclearly intelligible, legible and visible. Minimum requirements on important parameters such as font size, distance and contrast should therefore be laid down.
Amendment 116 #
2023/0290(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) To prevent misuse of warnings to circumvent the applicable safety requirements, the warnings provided for certain categories of toy should not be allowed if they conflict with the intended use of the toy. To ensure that supervisors are aware of any risks associated with the toy, it is necessary to ensure that the warnings are clearly intelligible, legible and visible.
Amendment 119 #
2023/0290(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) To facilitate compliance of the manufacturers with their obligations under this Regulation, manufacturers should be allowed to appoint an authorised representativ and to make sure they are always traceable, manufacturers established outside the Union should always appoint an authorised representative, and manufacturers established in the Union should be allowed to appoint one to carry out specific tasks on their behalf. Moreover, to ensure a clear and proportionate distribution of tasks between the manufacturer and the authorised representative, it is necessary to set out a list of tasks that manufacturers should be allowed to entrust the authorised representative with. Further, to ensure the enforceability and compliance with this Regulation, where a manufacturer established outside the Union appoints an authorised representative, the mandate should include the tasks set out in Article 4 of Regulation (EU) 2019/1020.
Amendment 120 #
2023/0290(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) Economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that the toys they place on the market do not jeopardisepose risks to the safety and health of children under normal and reasonably foreseeable conditions of use and misuse, and that they make available on the market only toys which comply with the relevant Union legislation.
Amendment 122 #
2023/0290(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) It is necessary to ensure that toys from third countries entering the Union market comply with all applicable Union requirements, and in particular that appropriate conformity assessment procedures have been carried out by manufacturers with regard to those toys. Importers should therefore ensure that the toys they place on the market comply with the applicable requirements, that conformity assessment procedures have been carried out and that productCE marking and technical documentation drawn up by manufacturers are available for inspection by the competent market surveillance authorities.
Amendment 123 #
2023/0290(COD)
Proposal for a regulation
Recital 34 a (new)
Recital 34 a (new)
(34 a) With regard to distance and online sales, this Regulation complements Regulation (EU) 2023/988 and Regulation (EU) No 2019/1020. Where there is no economic operator in the Union within the meaning of Article 4(1) of Regulation (EU) No 2019/1020, the online marketplace shall be considered to be the importer responsible for the conformity of the toys sold to consumers located in the Union, and thereby take on the importer’s responsibilities for the purposes of this Regulation.
Amendment 125 #
2023/0290(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) As the distributor makes a toy available on the market after the toy has been placed on the market by the manufacturer or the importer, the distributor should act with due care to ensure that the handling of the toy does not adversely affect the compliance of that toy with this Regulation.
Amendment 127 #
2023/0290(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Economic operators that either place a toy on the market under their own name or trademark or modify a toy in such a way that compliance with applicable requirements of this Regulation may be affected, should be considered to be manufacturers for the purposes of this Regulation and should assume the obligations of manufacturers.
Amendment 130 #
2023/0290(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) In order to facilitate the assessment of conformity with the requirements of this Regulation it is necessary to provide for a presumption of conformity for toys which are in conformity with the applicable harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council36 and published in the Official Journal of the European Union. _________________ 36 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
Amendment 131 #
2023/0290(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) In the absence of relevant harmonised standards, the Commission should be empowered to adopt implementing acts setting out common specifications for the essential requirements of this Regulation, provided that in doing so it duly respects the standardisation organisations’ role and functions, as an exceptional fall back solution to facilitate the manufacturer’s obligation to comply with the essential requirements, when the standardisation process is blocked, when the standards are insufficient or when there are delays in the establishment of appropriate harmonised standards.
Amendment 133 #
2023/0290(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Manufacturers should create a digital product passport to provide information on the compliance of toys with this Regulation and with any other Union legislation applicable to toys. The product passport should replace the EU declaration of conformity under Directive 2009/48/EC and include the elements necessary to assess the conformity of the toy with the applicable requirements and harmonised standards or other specifications. In order to facilitate checks on toys by market surveillance authorities and to allow the actors in the supply chain and consumers to access information on the toy, the information on the product passport should be provided digitally and in a directly accessible manner, through a data carrier affixed to the toy, its packaging or the accompanying documentation. Market surveillance authorities, customs authorities, economic operators and consumers should have immediate access to the information on the toy through the data carrier.
Amendment 137 #
2023/0290(COD)
Proposal for a regulation
Recital 56
Recital 56
(56) To ensure that toys comply with the essential requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Internal production control based on the manufacturer’s own responsibility for the conformity assessment is adequate where it has followed the harmonised standards, the reference of which has been published in the Official Journal of the European Union, or common specifications covering all the particular safety requirements for the toy. In cases where such harmonised standards or common specifications do not exist, the toy should be submitted to third party verification, in this case EU-type examination. The same should apply if one or more such standards has been published with a restriction in the Official Journal of the European Union, or if the manufacturer has not followed such standards or specifications completely, or only in part. TIn addition, the manufacturer should submit the toy to EU-type examination in cases where it considers that the nature, design, construction or purpose of the toy necessitates third party verification.
Amendment 139 #
2023/0290(COD)
Proposal for a regulation
Recital 60
Recital 60
(60) Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for toys to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified, and the monitoring of bodies already notified, cover also activities carried out by subcontractors and subsidiaries. In particular, Member States should take appropriate corrective measures as provided for in Regulation (EC) No 765/2008 in cases where a conformity assessment body would have excessive recourse to subsidiaries and subcontractors, in a manner that would call into question the competence of the notified body or its supervision by the notifying authority should be avoided.
Amendment 142 #
2023/0290(COD)
Proposal for a regulation
Recital 68
Recital 68
(68) In order to take into account technical and scientific progress or new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of amending this Regulation by adapting the specific warnings to be affixed on toys, adopting specific requirements concerning chemical substances in toys and granting or removing derogations to include specific uses allowed in toys of substances subject to generic prohibitions.
Amendment 143 #
2023/0290(COD)
Proposal for a regulation
Recital 71
Recital 71
(71) When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert and stakeholder level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making40 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 40 OJ L 123, 12.5.2016, p. 1.
Amendment 144 #
2023/0290(COD)
Proposal for a regulation
Recital 72
Recital 72
(72) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish the detailed technical requirements for the product passport for toys, and to determine whether a specific product or group of products is to be considered a toy for the purposes of this Regulation. In exceptional cases where it is necessary in order to address new emerging risks that are not appropriately addressed by the particular safety requirements, the Commission should be empowered to adopt implementingdelegated acts setting out specific measures against toys or categories of toys made available on the market which present a risk for children. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council41 . _________________ 41 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 151 #
2023/0290(COD)
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
This Regulation shall be applied taking due account of the precautionary principle.
Amendment 156 #
2023/0290(COD)
Proposal for a regulation
Article 2 – paragraph 3
Article 2 – paragraph 3
3. The Commission shall be empowered to adopt implementingdelegated acts determining whether or not specific products or categories of products fulfil the criteria set out in paragraph 1 of this Article and therefore can or cannot be considered toys within the meaning of this Regulation. Those implementingdelegated acts shall be adopted in accordance with the procedure set out in Article 50(2)47.
Amendment 160 #
2023/0290(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘economic operator’ means the manufacturer, the authorised representative, the importer, the distributor and, the fulfilment service provider and the online marketplace;
Amendment 171 #
2023/0290(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 23 a (new)
Article 3 – paragraph 1 – point 23 a (new)
(23 a) ‘harm’ means physical injury or any other damage to health, including mental health or long-term health effects;
Amendment 175 #
2023/0290(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 32
Article 3 – paragraph 1 – point 32
(32) ‘chemical toy’ means a toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult;
Amendment 180 #
2023/0290(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
Amendment 181 #
2023/0290(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1
Article 4 – paragraph 2 – subparagraph 1
Amendment 184 #
2023/0290(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 2
Article 4 – paragraph 2 – subparagraph 2
Amendment 196 #
2023/0290(COD)
Proposal for a regulation
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
Warnings shall be clearly visible to the consumer before the purchase, including in cases where the purchase is made through distance sales. Warnings shall be of sufficient size to ensure their visibility and legibility. In particular, warnings shall have the following characteristics: a) they shall stand out clearly from the background; b) a single font shall be used that is easily legible and without serifs; c) the x-height of the font size shall be equal to or greater than 1,4 mm; d) the distance between two lines shall be appropriate for the selected font size to be easily legible; e) the letter spacing shall be appropriate for the selected font to be easily legible.
Amendment 205 #
2023/0290(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. Manufacturers shall keep the technical documentation and the product passport for a period of at least 10 years after the last model of toy covered by that documentation and product passport has been placed on the market.
Amendment 206 #
2023/0290(COD)
Proposal for a regulation
Article 7 – paragraph 4 – subparagraph 2
Article 7 – paragraph 4 – subparagraph 2
When manufacturers,deemed appropriate with regard to the risks presented by a toy, consider it necessary for the protection of health and safety of consumers, manufacturers shall, carry out sample testing of marketed toys.
Amendment 210 #
2023/0290(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. Manufacturers shall ensure that toys bear a type, batch, serial or model number or other element allowing their identification, and which is easily visible and legible for consumers or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
Amendment 217 #
2023/0290(COD)
Proposal for a regulation
Article 7 – paragraph 8 – subparagraph 1
Article 7 – paragraph 8 – subparagraph 1
Where manufacturers consider, or have reason to believe, that a toy which they have placed on the market is not in conformity with this Regue applicable Union harmonisation legislation, they shall immediately take the corrective measures necessary to bring that toy into conformity, withdraw it or recall it, as appropriate.
Amendment 220 #
2023/0290(COD)
Proposal for a regulation
Article 7 – paragraph 8 – subparagraph 2 – point a
Article 7 – paragraph 8 – subparagraph 2 – point a
(a) the market surveillance authorities of the Member States in which they have made the toy available, via the Safety Business Gateway referred to in Article 26 of Regulation (EU) 2023/988, giving details, in particular, of any non- compliancethe risks to the health and safety to consumers and of any corrective measures taken; and
Amendment 223 #
2023/0290(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. A manufacturer may appoint an authorised representative by written mandatPrior to making a toy available on the Union market, manufacturers established outside the Union shall appoint an authorised representative by written mandate. A manufacturer established in the Union may also appoint one.
Amendment 225 #
2023/0290(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point -a (new)
Article 8 – paragraph 3 – point -a (new)
(-a) verify that the product passport and the technical documentation have been drawn up and that an appropriate conformity assessment procedure has been carried out by the manufacturer;
Amendment 227 #
2023/0290(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point a
Article 8 – paragraph 3 – point a
(a) keep the technical documentation at the disposal of national surveillance authorities and ensure that the product passport is available, in accordance with Article 17(2), for a period of at least 10 years after the last model of the toy covered by those documents has been placed on the market;
Amendment 228 #
2023/0290(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point b
Article 8 – paragraph 3 – point b
(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy in an official language which can be easily understood by that authority;
Amendment 230 #
2023/0290(COD)
Proposal for a regulation
Article 8 – paragraph 3 – point b a (new)
Article 8 – paragraph 3 – point b a (new)
(b a) where the authorised representative considers or has reason to believe that a toy poses risks to the health and safety or is otherwise non-compliant with this Regulation, inform the manufacturer thereof;
Amendment 242 #
2023/0290(COD)
Proposal for a regulation
Article 9 – paragraph 2 – subparagraph 2
Article 9 – paragraph 2 – subparagraph 2
Where importers consider, or have reason to believe, that a toy is not in conformity with the essential safety requirements, they shall notinform the manufacturer and refrain from placeing the toy on the market until it has been brought into conformity by the manufacturer.
Amendment 247 #
2023/0290(COD)
Proposal for a regulation
Article 9 – paragraph 6 – subparagraph 2
Article 9 – paragraph 6 – subparagraph 2
Where importers consider, or have reason to believe, that a toy that they have placed on the market presents a risk to health and safety of consumers and other end-users, they shall immediately inform the manufacturer, the competent national authorities of the Member States in which they made the toy available to that effect, the online matrkeplace, giving details, in particular, of the non-compliancerisk to health and safety of consumers and of any corrective measures taken.
Amendment 248 #
2023/0290(COD)
Proposal for a regulation
Article 9 – paragraph 7
Article 9 – paragraph 7
7. Importers shall, for a period of at least 10 years after the last model of the toy has been placed on the market, keep the unique product identifier of the toy at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Article 23 can be made available to those authorities, upon request.
Amendment 252 #
2023/0290(COD)
Proposal for a regulation
Article 9 – paragraph 11 a (new)
Article 9 – paragraph 11 a (new)
11 a. Where no importer, distributor or authorised representative can be identified and the toy is made available through an online marketplace, the provider of that online marketplace shall be considered the importer for the purposes of this Regulation and therefore be subject to the same obligations as the importer as set out in this article.
Amendment 253 #
2023/0290(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. When making a toy available on the market, distributors shall act with due care in relation to the requirements ofDistributors shall only make available on the market toys complying with this Regulation.
Amendment 258 #
2023/0290(COD)
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 2
Article 10 – paragraph 2 – subparagraph 2
Where distributors consider, or have reason to believe, that a toy is not in conformity with the essential safety requirements, they shall not makeinform the manufacturer and refrain from making the toy available on the market until it has been brought into conformity by the manufacturer.
Amendment 262 #
2023/0290(COD)
Proposal for a regulation
Article 11 – title
Article 11 – title
Cases in which obligations of manufacturers apply to importers and distribuother economic operators
Amendment 265 #
2023/0290(COD)
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
An importer or, a distributor or a provider of an online marketplace shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 7, where such importer or, distributor or provider of an online marketplace places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements of this Regulation may be affected.
Amendment 286 #
2023/0290(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point b
Article 17 – paragraph 2 – point b
(b) state that compliance of the toy with the requirements set out in Union legislation applicable to toys and in particular this Regulation and, in particular, the essential safety requirements, has been demonstrated;
Amendment 286 #
2023/0290(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point b
Article 17 – paragraph 2 – point b
(b) state that compliance of the toy with the requirements set out in Union legislation applicable to toys and in particular this Regulation and, in particular, the essential safety requirements, has been demonstrated;
Amendment 288 #
Amendment 288 #
Amendment 292 #
2023/0290(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point g
Article 17 – paragraph 2 – point g
(g) be available for a period of at least 10 years after the toylast toy model is placed on the market, also in cases of insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
Amendment 292 #
2023/0290(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point g
Article 17 – paragraph 2 – point g
(g) be available for a period of at least 10 years after the toylast toy model is placed on the market, also in cases of insolvency, a liquidation or a cessation of activity in the Union of the economic operator that created the product passport;
Amendment 298 #
2023/0290(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. The data carrier shall be physically present on the toy or on a label attached to the toy, in accordance with the implementing act adopted in accordance with paragraph 10. In the case of small toys and toys consisting of small parts, the data carrier may alternativelyshall be affixed to its packaging. It shall be clearly visible to the consumer before any purchase and to market surveillance authorities, including in cases where the toy is made available through distance sales. It shall also be accompanied by the statement “More information on the product is available on the website of the manufacturer” or by a similar statement.
Amendment 298 #
2023/0290(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. The data carrier shall be physically present on the toy or on a label attached to the toy, in accordance with the implementing act adopted in accordance with paragraph 10. In the case of small toys and toys consisting of small parts, the data carrier may alternativelyshall be affixed to its packaging. It shall be clearly visible to the consumer before any purchase and to market surveillance authorities, including in cases where the toy is made available through distance sales. It shall also be accompanied by the statement “More information on the product is available on the website of the manufacturer” or by a similar statement.
Amendment 311 #
2023/0290(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. All information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable. The product passport shall be designed and operated in an accessible manner, and incorporate the principle of security and privacy by design.
Amendment 311 #
2023/0290(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. All information included in the product passport shall be based on open standards developed with an interoperable format and shall be machine readable, structured and searchable. The product passport shall be designed and operated in an accessible manner, and incorporate the principle of security and privacy by design.
Amendment 313 #
2023/0290(COD)
Proposal for a regulation
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3 a. Consumers shall not be requested to register, download, or to provide a password to access the product passport. A functionality shall allow consumers to place alerts about toys that present a risk to their health and safety through a separate section of the Safety Gate Portal pursuant to Article 34(3) of Regulation EU/2023/988.
Amendment 313 #
2023/0290(COD)
Proposal for a regulation
Article 18 – paragraph 3 a (new)
Article 18 – paragraph 3 a (new)
3 a. Consumers shall not be requested to register, download, or to provide a password to access the product passport. A functionality shall allow consumers to place alerts about toys that present a risk to their health and safety through a separate section of the Safety Gate Portal pursuant to Article 34(3) of Regulation EU/2023/988.
Amendment 319 #
2023/0290(COD)
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Economic operators mayshall not track, analyse or use any usage information for purposes other than what is absolutely and strictly necessary for providing the information on the product passport online. End-users shall not be required to install any software, register or otherwise process personal data to access the digital product passport online.
Amendment 319 #
2023/0290(COD)
Proposal for a regulation
Article 18 – paragraph 6
Article 18 – paragraph 6
6. Economic operators mayshall not track, analyse or use any usage information for purposes other than what is absolutely and strictly necessary for providing the information on the product passport online. End-users shall not be required to install any software, register or otherwise process personal data to access the digital product passport online.
Amendment 333 #
2023/0290(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
(c a) assess the risks, including to mental health, that may emerge when the toy is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse.
Amendment 333 #
2023/0290(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
Article 21 – paragraph 2 – subparagraph 1 – point c a (new)
(c a) assess the risks, including to mental health, that may emerge when the toy is used in accordance with its intended purpose and under conditions of reasonably foreseeable misuse.
Amendment 337 #
2023/0290(COD)
Proposal for a regulation
Article 22 – paragraph 3 – point d a (new)
Article 22 – paragraph 3 – point d a (new)
(d a) toys for children under 36 months which contain chemical mixtures;
Amendment 337 #
2023/0290(COD)
Proposal for a regulation
Article 22 – paragraph 3 – point d a (new)
Article 22 – paragraph 3 – point d a (new)
(d a) toys for children under 36 months which contain chemical mixtures;
Amendment 338 #
2023/0290(COD)
Proposal for a regulation
Article 22 – paragraph 3 – point d b (new)
Article 22 – paragraph 3 – point d b (new)
(d b) connected toys or toys that make use of artificial intelligence systems as defined in Regulation xxx.
Amendment 338 #
2023/0290(COD)
Proposal for a regulation
Article 22 – paragraph 3 – point d b (new)
Article 22 – paragraph 3 – point d b (new)
(d b) connected toys or toys that make use of artificial intelligence systems as defined in Regulation xxx.
Amendment 352 #
2023/0290(COD)
Proposal for a regulation
Article 41 – paragraph -1 (new)
Article 41 – paragraph -1 (new)
-1. Market surveillance authorities of the Member States shall perform their activities taking due account of the precautionary principle.
Amendment 352 #
2023/0290(COD)
Proposal for a regulation
Article 41 – paragraph -1 (new)
Article 41 – paragraph -1 (new)
-1. Market surveillance authorities of the Member States shall perform their activities taking due account of the precautionary principle.
Amendment 372 #
2023/0290(COD)
Proposal for a regulation
Article 46 – paragraph 5
Article 46 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex I and III in order to adapt it to technical and scientific progress.
Amendment 372 #
2023/0290(COD)
Proposal for a regulation
Article 46 – paragraph 5
Article 46 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 47 to amend Annex I and III in order to adapt it to technical and scientific progress.
Amendment 378 #
2023/0290(COD)
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for an indeterminatefive years from … [the date of entry into force of the Regulation].The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of timean identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 378 #
2023/0290(COD)
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. The power to adopt delegated acts referred to in Article 46 shall be conferred on the Commission for an indeterminatefive years from … [the date of entry into force of the Regulation].The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of timean identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 380 #
2023/0290(COD)
Proposal for a regulation
Article 47 – paragraph 6
Article 47 – paragraph 6
6. Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of twohree months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by twohree months at the initiative of the European Parliament or of the Council.
Amendment 380 #
2023/0290(COD)
Proposal for a regulation
Article 47 – paragraph 6
Article 47 – paragraph 6
6. Delegated acts adopted pursuant to Article 46 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of twohree months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by twohree months at the initiative of the European Parliament or of the Council.
Amendment 382 #
2023/0290(COD)
Proposal for a regulation
Article 51 – paragraph 1 – point b a (new)
Article 51 – paragraph 1 – point b a (new)
(b a) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits;
Amendment 382 #
2023/0290(COD)
Proposal for a regulation
Article 51 – paragraph 1 – point b a (new)
Article 51 – paragraph 1 – point b a (new)
(b a) the effective implementation of this Regulation, in particular for the purpose of inspections, investigations or audits;
Amendment 388 #
2023/0290(COD)
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation] may continue to be made available on the market until … [OP please insert the date = the first day of the month following 4230 months after the date of entry into force of this Regulation].
Amendment 388 #
2023/0290(COD)
Proposal for a regulation
Article 54 – paragraph 1
Article 54 – paragraph 1
1. Toys placed on the market in conformity with Directive 2009/48/EC before … [OP please insert the date = the first day of the month following 30 months after the date of entry into force of this Regulation] may continue to be made available on the market until … [OP please insert the date = the first day of the month following 4230 months after the date of entry into force of this Regulation].
Amendment 390 #
2023/0290(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Chapter VII and 5.1 of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and 45 of Directive 2009/48/EC to toys which were placed on the market in conformity with that Directive before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation], including toys for which a procedure has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation].
Amendment 390 #
2023/0290(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Chapter VII and 5.1 of this Regulation shall apply mutatis mutandis instead of Article 42, 43 and 45 of Directive 2009/48/EC to toys which were placed on the market in conformity with that Directive before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation], including toys for which a procedure has already been initiated under Article 42 or 43 of Directive 2009/48/EC before … [PO insert date: the first day of the month following 3012 months after the date of entry into force of this Regulation].
Amendment 394 #
2023/0290(COD)
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [PO insert date: the first day of the month following 4230 months after the date of entry into force of this Regulation], unless they expire before that date.
Amendment 394 #
2023/0290(COD)
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. EC type-examination certificates issued in accordance with Article 20 of Directive 2009/48/EC shall remain valid until … [PO insert date: the first day of the month following 4230 months after the date of entry into force of this Regulation], unless they expire before that date.
Amendment 396 #
2023/0290(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. By … [OP please insert the date = the first day of the month following 360 months after the date of entry into force of this Regulation] and every 5 years thereafter, the Commission shall carry out an evaluation of this Regulation. The Commission shall submit a report to the European Parliament and to the Council on the main findings.
Amendment 396 #
2023/0290(COD)
Proposal for a regulation
Article 55 – paragraph 1
Article 55 – paragraph 1
1. By … [OP please insert the date = the first day of the month following 360 months after the date of entry into force of this Regulation] and every 5 years thereafter, the Commission shall carry out an evaluation of this Regulation. The Commission shall submit a report to the European Parliament and to the Council on the main findings.
Amendment 400 #
2023/0290(COD)
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
It shall apply from … [OP please insert the date = the first day of the month following 3024 months after the date of entry into force of this Regulation].
Amendment 400 #
2023/0290(COD)
Proposal for a regulation
Article 56 – paragraph 2
Article 56 – paragraph 2
It shall apply from … [OP please insert the date = the first day of the month following 3024 months after the date of entry into force of this Regulation].
Amendment 404 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 3
Annex I – Part II – point 3
3. sports equipment, including roller skates, inline skates, and skateboards, scooters and other means of transport intended for children with a body mass of more than 20 kg;
Amendment 404 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 3
Annex I – Part II – point 3
3. sports equipment, including roller skates, inline skates, and skateboards, scooters and other means of transport intended for children with a body mass of more than 20 kg;
Amendment 405 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 5
Annex I – Part II – point 5
Amendment 405 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 5
Annex I – Part II – point 5
Amendment 408 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 8
Annex I – Part II – point 8
Amendment 408 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 8
Annex I – Part II – point 8
Amendment 411 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 15
Annex I – Part II – point 15
15. interactive software, intended for leisure and entertainment, such as computer games, and their storage mediaand their storage media, unless the interactive software is either specifically designed for and targeted at children or can be reasonably expected to be played by children, such as computer and smartphone games;
Amendment 411 #
2023/0290(COD)
Proposal for a regulation
Annex I – Part II – point 15
Annex I – Part II – point 15
15. interactive software, intended for leisure and entertainment, such as computer games, and their storage mediaand their storage media, unless the interactive software is either specifically designed for and targeted at children or can be reasonably expected to be played by children, such as computer and smartphone games;
Amendment 414 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part I – point 9
Annex II – Part I – point 9
9. Toys shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The maximum values shall not exceed half of those set in Directive 2003/10/ EEC.
Amendment 414 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part I – point 9
Annex II – Part I – point 9
9. Toys shall be designed and manufactured in such a way, in terms of the maximum values for impulse noise and continuous noise, that the sound from them is not able to impair children’s hearing. The maximum values shall not exceed half of those set in Directive 2003/10/ EEC.
Amendment 421 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part III – point 2
Annex II – Part III – point 2
2. Toys that are themselves substances or mixtures, such as fingerpaint or modeling clay, shall comply also with Regulation (EC) No 1272/2008 as well as with the labelling requirements laid down in Regulation (EC) No 1223/2009.
Amendment 421 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part III – point 2
Annex II – Part III – point 2
2. Toys that are themselves substances or mixtures, such as fingerpaint or modeling clay, shall comply also with Regulation (EC) No 1272/2008 as well as with the labelling requirements laid down in Regulation (EC) No 1223/2009.
Amendment 424 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part III – point 8
Annex II – Part III – point 8
8. Cosmetic toys, such as play cosmetics for dolls or children, shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the Council43 . _________________ 43 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
Amendment 424 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part III – point 8
Annex II – Part III – point 8
8. Cosmetic toys, such as play cosmetics for dolls or children, shall comply with the compositional and labelling requirements laid down in Regulation (EC) No 1223/2009 of the European Parliament and of the Council43 . _________________ 43 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
Amendment 427 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part V – point 2
Annex II – Part V – point 2
2. A toy intended for use by children under 36 months or intended to be put in the mouth shall be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer’s instructions.
Amendment 427 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part V – point 2
Annex II – Part V – point 2
2. A toy intended for use by children under 36 months or intended to be put in the mouth shall be designed and manufactured in such a way that it can be cleaned. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. The toy shall fulfil the safety requirements also after having been cleaned in accordance with this point and the manufacturer’s instructions.
Amendment 432 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part A – point 2 a (new)
Annex II – Part A – point 2 a (new)
2 a. Toys shall not contain per- and polyfluorinated alkyl substances (PFASs) and bisphenols, unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material.
Amendment 432 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part A – point 2 a (new)
Annex II – Part A – point 2 a (new)
2 a. Toys shall not contain per- and polyfluorinated alkyl substances (PFASs) and bisphenols, unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed the limit of detection in the homogeneous material.
Amendment 433 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part A – point 3 a (new)
Annex II – Part A – point 3 a (new)
3 a. Toys intended for use by children under 36 months or toys intended to be placed in the mouth shall not contain any fragrances.
Amendment 433 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part A – point 3 a (new)
Annex II – Part A – point 3 a (new)
3 a. Toys intended for use by children under 36 months or toys intended to be placed in the mouth shall not contain any fragrances.
Amendment 435 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part A – point 4 – introductory part
Annex II – Part A – point 4 – introductory part
4. Toys shall not contain the following fragrance allergens unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg:the limit of detection.
Amendment 435 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part A – point 4 – introductory part
Annex II – Part A – point 4 – introductory part
4. Toys shall not contain the following fragrance allergens unless their presence in the toy is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg:the limit of detection.
Amendment 437 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part B – point 1 – introductory part
Annex II – Part B – point 1 – introductory part
1. The names of the following fragrance allergens shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, as well as in the product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 100 mg/kg:
Amendment 437 #
2023/0290(COD)
Proposal for a regulation
Annex II – Part B – point 1 – introductory part
Annex II – Part B – point 1 – introductory part
1. The names of the following fragrance allergens shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, as well as in the product passport, if those allergens are added to a toy, where they are present in the toy or any component thereof at concentrations exceeding 100 mg/kg:
Amendment 440 #
2023/0290(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
Annex III – point 1 – paragraph 2 – introductory part
All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram asuch as the followings:
Amendment 440 #
2023/0290(COD)
Proposal for a regulation
Annex III – point 1 – paragraph 2 – introductory part
Annex III – point 1 – paragraph 2 – introductory part
All warnings shall be preceded by the word ‘Warning’ or, alternatively, by a generic pictogram asuch as the followings:
Amendment 451 #
2023/0290(COD)
Proposal for a regulation
Annex V – point 5
Annex V – point 5
(5) Copies of documents that the manufacturer has submitted to any notified body, where relevant;
Amendment 451 #
2023/0290(COD)
Proposal for a regulation
Annex V – point 5
Annex V – point 5
(5) Copies of documents that the manufacturer has submitted to any notified body, where relevant;
Amendment 21 #
2023/0132(COD)
Proposal for a directive
Recital 3
Recital 3
(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and est, ensure access to innovative and established medicines for patients and improve affordabilished medicines for patientty of these medicines, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; and create a balanced and competitive system that keeps medicines affordable for health systems whileand patients while particularly rewarding targeted innovation that improves access to medicinal products in all Member States, where they address unmet medical needs and where preclincial studies and development has taken place in the Union, reinforcing our industrial ecosystems.
Amendment 29 #
2023/0132(COD)
Proposal for a directive
Recital 6
Recital 6
(6) The regulatory framework for medicinal products for human use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products.
Amendment 32 #
2023/0132(COD)
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and, innovation that reaches patients and improves access across the Union and innovation that stems from preclinical studies developed in the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 35 #
2023/0132(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) It is however, difficult to establish a direct link between incentives offered nowadays at Union level and Union competitiveness in the pharmaceutical sphere vis a vis third country based companies. While incentives can make the EU a more attractive market for industry, they remain agnostic to medicines´ geographical origin. Medicines originating from third country based companies are eligible to all EU incentives. Equally, EU based innovative companies can benefit from incentives elsewhere if they sell their products in these markets. Therefore a reduction in the regulatory data protection period does not harm EU companies vis a vis non EU companies coming to the EU market in terms of competitiveness.
Amendment 37 #
2023/0132(COD)
Proposal for a directive
Recital 11 b (new)
Recital 11 b (new)
(11 b) However, to improve research and development in the pharmaceutical sphere stemming from the Union, as well as contributing to open EU strategic autonomy, it could be beneficial to establish a direct link between preclinical studies conducted in the Union and an incentive pronlonging data protection for a medicinal product. Therefore, an incentive to extend the data protection period is proposed where a company can demonstrate this.
Amendment 41 #
2023/0132(COD)
Proposal for a directive
Recital 15
Recital 15
(15) In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, certain definitions and derogations should be modified, so as to avoid any doubt as to the applicable legislation. With the same objective of clarifying situations when a product fully falls within the definition of a medicinal product and also meet the definition of other regulated products, the rules for medicinal products under this Directive applyAgency and the advisory and regulatory bodies established in other Union legislation, as relevant, should engage in consultations, in order to find consensus on the regulatory status of the product or the application of Union law to the borderline product in question. Where necessary, the Commission should be empowered to take the decision on the regulatory status or applicability of legal rules to the borderline product,the assessment and conclusions of which should be made publicly available. Furthermore, for transparency purposes, the respective opinions and conclusions of the Agency and the other advisory and regulatory bodies established in other Union legislation should be made publicly available. Furthermore, to ensure the clarity of applicable rules, it is also appropriate to improve the consistency of the terminology of the pharmaceutical legislation and clearly indicate the products excluded from the scope of this Directive.
Amendment 42 #
2023/0132(COD)
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17 a) For SoHO derived medicinal products each Member State shoud ensure through public service obligations that those manufacturers provide an appropriate and continuous supply of SoHO derived medicinal products to patients in their territory. Member States should negotiate fair and transparent prices for SoHO derived medicinal products that are derived from altruistic and unpaid donations. Member States should also ensure that affordable SoHO derived medicinal products are available to patients in their territory. In this regard, manufactureres of these products should report annually to authorities on the quantities prepared and the amount supplied for public use.
Amendment 46 #
2023/0132(COD)
Proposal for a directive
Recital 18
Recital 18
(18) Advanced therapy medicinal products that are prepared on a non- routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.
Amendment 47 #
2023/0132(COD)
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) Hospital exemption pathway is a crucial way of providing patients with access to innovative and affordable treatments that may not be available through other channels. Any limitations to this pathway should avoided, but only based on efficacy, quality and safety criteria, without time restrictions or restrictions on quantities. Competent authorities must guarantee that the authorisation of other products through the centralized procedure does not adversely affect the activities and responsibilities of developers functioning under the hospital exemption. The Agency, as well as competent authorities at the national level, should support academic institutions and other non-profit entities through the requirements of the hospital exemption clause and, when adequate, should provide guidance through centralised marketing authorisation procedure.
Amendment 53 #
2023/0132(COD)
Proposal for a directive
Recital 27
Recital 27
(27) Certain particulars and documentation that are normally to be submitted with an application for a marketing authorisation should not be required if a medicinal product is a generic medicinal product or a similar biological medicinal product (biosimilar) that is authorised or has been authorised in the Union. Both generic and biosimilar medicinal products are important to ensure access of medicinal products to a wider patient population at more affordable prices and create a competitive internal market . In a joint statement authorities of the Member States confirmed that the experience with approved biosimilar medicinal products over the past 15 years has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference medicinal product and are therefore interchangeable and can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product.
Amendment 54 #
2023/0132(COD)
Proposal for a directive
Recital 31
Recital 31
(31) Directive 2010/63/EU of the European Parliament and of the Council43[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. _________________ 43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 55 #
2023/0132(COD)
Proposal for a directive
Recital 39
Recital 39
(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure. A Member State who did not join the initital application for the decentralised procedure within 30 days of the sumission of the application should still have a second opportunity to opt into the procedure at a later point, in this case they should immeditately inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 57 #
2023/0132(COD)
Proposal for a directive
Recital 44
Recital 44
(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States, often due to profitability considerations. National pricing and reimbursement policies, the size of the population, the organisation of health systems, and national administrative procedures are other factors influencing market launch and patient access.
Amendment 58 #
2023/0132(COD)
Proposal for a directive
Recital 45
Recital 45
(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions 45 and a resolution of the European Parliament 46 . Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. _________________ 45 Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31). Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02). 46 European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI)) Shortages of medicines, 2020/2071(INI)Puting in place tolls to evaluate access to medicines at a Union level is key to follow-up on the results achieved through incentives.
Amendment 61 #
2023/0132(COD)
Proposal for a directive
Recital 48
Recital 48
(48) While pricing and reimbursement decisions are a Member State competence, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad- hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost- effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. Such procurement efforts should be based on the principle of the ‘most economically advantageous tender’ (‘MEAT’ criteria), which aims to ensure the best value for money rather than most economically advantageous product. Such an approach could also help in defining adequate supply in relation to critical medicines and, thereby, compensate and incentivise industry, and support the application of these criteria in a coordinated way, at EU level. Predictability of supply would also be helped by medium-term contractual incentives to diversify and attract the next generation of manufacturing investments in Europe. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.
Amendment 67 #
2023/0132(COD)
Proposal for a directive
Recital 49 a (new)
Recital 49 a (new)
(49 a) Practices in procurement procedures for medicines differ between Member States and long-term availability is rarely a primary consideration. The 2014 Procurement Directive encourages a more strategic approach through award criteria, including criteria beyond price. Using the lowest price as the main selection criterion may reduce incentives for the industry to build for long-term supply in the EU. At the same time, vulnerability may be increased when public procurement procedures award contracts to a single company. Where challenges with access to a critical medicine and related affordability may be an issue, Member States can work together to increase buying power. Joint procurement between Member States can act as a powerful tool to improve access, affordability and security of supply, of particular benefit in smaller EU markets. This can improve the negotiating position of Member States to incentivise production capacities, as well as diversifying supply chains. In specific cases, those instruments could also support enhanced predictability through multi-annual contracts. The joint procurement of medicines or on Member States’ behalf in the case of the COVID- 19 pandemic, for example, provided a powerful tool to improve access, affordability, and security of supply, was of particular benefit to smaller EU Member States with less economic power.
Amendment 79 #
2023/0132(COD)
Proposal for a directive
Recital 52
Recital 52
(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence- based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States. National competent authorities and the Agency should promote, when possible, the use of comparative studies when giving regulatory advise prior to marketing authorization for medicinal products.
Amendment 91 #
2023/0132(COD)
Proposal for a directive
Recital 56
Recital 56
(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. In the case where a Member State does not react to the application by the marketing authoirsation holder within the deadline provided, it shall be considered that a statement of non objection has been provided and the condition in that Member State should be waived. The Commission should ensure that marketing authorisation holders are not unduly prevented from receiving the incentives for actions beyond their control.
Amendment 103 #
2023/0132(COD)
Proposal for a directive
Recital 61
Recital 61
(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle asafeguard public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address thea crisis or safeguard public health interests as determined on a Member State level. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle asafeguard public health emergency.. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.
Amendment 104 #
2023/0132(COD)
Proposal for a directive
Recital 61 a (new)
Recital 61 a (new)
(61 a) The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for a possibility, under conditions, to issue compulsory licences. This provides governments the authority to grant the use of a patented invention without the consent of the patent owner. The Doha Declaration on the TRIPS Agreement and Public Health provides that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted.
Amendment 107 #
2023/0132(COD)
Proposal for a directive
Recital 62
Recital 62
(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection in cases ofto safeguard public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.
Amendment 110 #
2023/0132(COD)
Proposal for a directive
Recital 63
Recital 63
(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requiremeThe timely entry of generics and biosimilars onto the Union market is importants, necessarotably to obtain cregulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being consideredase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patient or SPC infringement. The application of this limited exemption is however fragmented across the Union ands in the EU. The importance of such timely entry has been underlined by the Council in it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confinedclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies and, trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, withought this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval processbeing considered patent or Supplementary Protection Certificate (SPC) infringement.
Amendment 114 #
2023/0132(COD)
Proposal for a directive
Recital 63 a (new)
Recital 63 a (new)
(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State) of the resulting final medicinal products obtained for the purposes of the regulatory approval process.
Amendment 119 #
2023/0132(COD)
Proposal for a directive
Recital 64
Recital 64
(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct studactivities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that periodaforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 125 #
2023/0132(COD)
Proposal for a directive
Recital 65 a (new)
Recital 65 a (new)
(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anticompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.
Amendment 127 #
2023/0132(COD)
Proposal for a directive
Recital 68 a (new)
Recital 68 a (new)
(68 a) In line with European Green Deal and the European Union Strategic Approach to Pharmaceuticals in the Environment, this regulatory framework should also contribute to avoiding potential risks to the environment. The evaluation of the framework showed that strengthened measures to reduce the environmental impact of medicinal products in the would be necessary.
Amendment 130 #
2023/0132(COD)
Proposal for a directive
Recital 69 a (new)
Recital 69 a (new)
(69 a) There is strong scientific evidence that the emissions of active substances during manufacturing are a threat to the environment and public health. Therefore, the requirements to protect the environment and public health should be extended in order to cover the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal.
Amendment 131 #
2023/0132(COD)
Proposal for a directive
Recital 70
Recital 70
(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. The proven efficacy and safety of a medicinal product for human use should remain a top criteria in terms of marketing authorisation, however applicants for marketing authorisation should ensure they complete the ERA in parallel with the marketing authorisation application to be able sufficiently mitigate negative environmental impacts. The ERA should also evaluate the risks to the environment and public health, including antimicrobial resistance that arise in the manufacturing of medicinal products.If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated in a timely manner when new data or knowledge about relevant risks become available and risk mitigation measures should be adapted accordingly. Moreover, to take into account the additional exposure resulting from the use of the medicinal product, the ERA should be updated in any case five years after the initial authorisation.
Amendment 136 #
2023/0132(COD)
Proposal for a directive
Recital 70 a (new)
Recital 70 a (new)
(70 a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder it may still be placed on the market for reasons in the interest of public health, and with certain post authorisation conditions and oblgiations. Where a medicinal product has been authorised and the ERA is imcomplete for the reason above, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post authorisation obligations.
Amendment 137 #
2023/0132(COD)
Proposal for a directive
Recital 70 b (new)
Recital 70 b (new)
(70 b) Detailed requirements for an ERA should be set out in the annexes to this Directive for medicinal products that have been authorised prior to October 2005, i.e. prior to the requirement of submitting an ERA, specific provisions should be introduced to set up a programme for the environmental risk assessement of those products that are identified as potentially harmful to the environment. Moreover, the establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance based review (‘monograph’) system could be potential alternative. Such a system should be set up by the Agency following a positive recommendation of the Commission.
Amendment 141 #
2023/0132(COD)
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to the proliferation of antimicrobial resistance (“AMR”), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing.
Amendment 150 #
2023/0132(COD)
Proposal for a directive
Recital 93
Recital 93
(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.
Amendment 152 #
2023/0132(COD)
Proposal for a directive
Recital 100
Recital 100
(100) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance and digitalisation.
Amendment 153 #
2023/0132(COD)
Proposal for a directive
Recital 105
Recital 105
(105) Experience has shown the need to maintain to a certain extent the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives when it has a functionality beyond colouring. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.
Amendment 154 #
2023/0132(COD)
Proposal for a directive
Recital 109
Recital 109
(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.
Amendment 163 #
2023/0132(COD)
Proposal for a directive
Recital 129
Recital 129
(129) Where Member States decide thatshould make the package leaflet should be made available in principle onlyavailable electronically, and they should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patientsprovided.. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet. However, Member States may choose to use only electronic leaflets for a limited range of medicinal products dispensed to in hospital patients where the provision of medical information can be ensured by health professional. The Commission should be empowered in the future to, by means of delegated acts, transition completely to electronic leaflets.
Amendment 165 #
2023/0132(COD)
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public and private support to the research and development of medicinal products, the reporting of public and private contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public finanThis should apply also to any independent legal entity from which it obtained a license in relation to the medicinal product in its previous phases of development. The information should be dissagregated to each stage of drug research and development, basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal support, such as direct grants or contractproduct; as well as post-market studies. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct and indirect financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.
Amendment 169 #
2023/0132(COD)
Proposal for a directive
Recital 133
Recital 133
(133) In order to ensure a harmonised and consistent reporting of public and private contribution for the development of a particular medicinal products, the Commission should be able to adopt implementing acts to clarify the principles and format that the marketing authorisation holder should adhere to when reporting this information.
Amendment 170 #
2023/0132(COD)
Proposal for a directive
Recital 135
Recital 135
(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria ensuring high standards of protection. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council[65 ]. It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them. _________________ 65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).
Amendment 173 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 4
Article 1 – paragraph 4
4. In cases where, taking into account all its characteristics, questions arise as to the regulatory status of product or a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union law, the provisions of this Directive shall prevailegislation, the Agency and the advisory and regulatory bodies established in other Union legislation shall consult as relevant, in order to find consensus on the regulatory status of the product or the application of Union law to the product. Where the Agency and the advisory and regulatory bodies established in other Union legislation cannot reach consensus on the regulatory status or Union law applicable to the product: (a) The Commission shall be empowered to take a decision on the regulatory status or the Union law applicable to the law in question, duly taking into account the relevant opinions and conclusions of the Agency and other advisory bodies and regulatory bodies established under Union law. This decision along with the supporting analysis and conclusion shall be made publicly available. (b) For transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory and regulatory bodies should be made publicly available.
Amendment 174 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 6
Article 1 – paragraph 6
Amendment 177 #
2023/0132(COD)
Proposal for a directive
Article 1 – paragraph 10
Article 1 – paragraph 10
Amendment 179 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 1
Article 2 – paragraph 1
1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).
Amendment 184 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 3
Article 2 – paragraph 3
3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 [69] respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. _________________ 69 Regulation (EC) No 1394/2007 of the European ParliamentThis shall include site inspections and GMP CPF accreditation, as well as traceability and pharmacovigilance plans and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1)evaluation of the preclinical and clinical data generated by the applicant.
Amendment 185 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3set the requirements for the collection and reporting of such data, in a structured and standarized way that allows obtaining more robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms.
Amendment 189 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4 a. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to assist them through the requirements of the hospital exemption clause. In cases where a product under hospital exemption becomes a suitable candidate to begin a centralized marketing authorization procedure, competent authorities shall assist non-profit and academic institutions also through this authorization process.
Amendment 194 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, reimbursement prices, and public and private contributions to the development of the product; which shall be updated regularly.
Amendment 197 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point b
Article 2 – paragraph 7 – subparagraph 1 – point b
(b) the format for collection and reporting of data referred to in paragraph 3 and 4;
Amendment 200 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.;
Amendment 201 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)
Article 2 – paragraph 7 – subparagraph 1 – point d a (new)
(d a) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause and the centralised marketing authorisation procedure.
Amendment 206 #
2023/0132(COD)
Proposal for a directive
Article 2 – paragraph 8 a (new)
Article 2 – paragraph 8 a (new)
8 a. Competent authorities shall guarantee that the authorization of products through the centralized procedure shall not adversely affect the activities and responsibilities of developers functioning under the hospital exemption as outlined in paragraphs 3 and 4.
Amendment 207 #
2023/0132(COD)
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility, or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.
Amendment 214 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 10 a (new)
Article 4 – paragraph 1 – point 10 a (new)
(10 a) 'clock stop’ means a period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.
Amendment 229 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 33
Article 4 – paragraph 1 – point 33
(33) ‘environmental risk assessment’ means the evaluation of the risks and potential risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use, manufacturing and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;
Amendment 240 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 70 a (new)
Article 4 – paragraph 1 – point 70 a (new)
(70 a) Decentralised manufacturing means a production model where manufacturing of medicinal products needs to take place in local sites close to patients.
Amendment 241 #
2023/0132(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations as well as those obtained by this marketing authorisation holder according to article 9 to 12 shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.
Amendment 243 #
2023/0132(COD)
Proposal for a directive
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
Article 6 – paragraph 5 – subparagraph 1 – point a a (new)
(a a) in the absence of comparative studies, a justification to substantiate the reasons why the above mentioned studies could not be conducted;
Amendment 245 #
2023/0132(COD)
Proposal for a directive
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available. The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.
Amendment 246 #
2023/0132(COD)
Proposal for a directive
Article 9 – paragraph 3 – subparagraph 1
Article 9 – paragraph 3 – subparagraph 1
Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted. In this, unless the applicant of the generic product is also the MAH or a related company of the reference medicinal product. In the latter case the complete dossier should be submitted. In the former case,, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.
Amendment 247 #
2023/0132(COD)
Proposal for a directive
Article 10 – paragraph 1
Article 10 – paragraph 1
In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non- clinical tests orand clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon ino the extent necessary to demonstrate (essential) similarity to the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product in any additional indication.
Amendment 251 #
2023/0132(COD)
Proposal for a directive
Article 13 – paragraph 1
Article 13 – paragraph 1
In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non- clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature and demonstration that this literature is relevant for the applied product.
Amendment 264 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior review and approval by the competent authority.
Amendment 265 #
2023/0132(COD)
Proposal for a directive
Article 17 – paragraph 2
Article 17 – paragraph 2
2. The competent authority mayshall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.
Amendment 273 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 1
Article 22 – paragraph 1
1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the duly justified reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.
Amendment 278 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 2 – introductory part
Article 22 – paragraph 2 – introductory part
2. The ERA shall evaluate the possible risks to the environment due to the use and disposal of the medicinal product according to the requirements referred to in Annex II . It shall indicate whether the medicinal product or any of its ingredients or other constituents is one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:
Amendment 285 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2 a. With regards to risks resulting from manufacturing the ERA shall provide information on discharged and emissions of the active susbtance(s) and other environmentally relevant susbtances according to the requirements referred to in Annex II.
Amendment 288 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU or in the cases where risks to the environment are identified in the scientific guidelines drawn up by the Agency on the ERA requirements for medicinal products for human use as referred to in paragraph 5. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 298 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 5
Article 22 – paragraph 5
5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use including environmental risk mitigation measures thereof. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) on, the European Centre of Disease Control (ECDC) and other relevant stakeholders, including those managing residues from medicinal products and wastewater treatment the drafting of these scientific guidelines.
Amendment 302 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA, including updates on the emissions of the medicinal product in manufacturing effluents. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, the collation of sales data and environmental exposure data.
Amendment 302 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 1
Article 22 – paragraph 6 – subparagraph 1
The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA, including updates on the emissions of the medicinal product in manufacturing effluents. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, the collation of sales data and environmental exposure data.
Amendment 306 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2
Article 22 – paragraph 6 – subparagraph 2
For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment and to update missing information in relation to risk mitigation measures referred to in paragraph 3.
Amendment 306 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 6 – subparagraph 2
Article 22 – paragraph 6 – subparagraph 2
For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment and to update missing information in relation to risk mitigation measures referred to in paragraph 3.
Amendment 309 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 7
Article 22 – paragraph 7
7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERAand shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.
Amendment 309 #
2023/0132(COD)
Proposal for a directive
Article 22 – paragraph 7
Article 22 – paragraph 7
7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERAand shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.
Amendment 316 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.
Amendment 316 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 3012 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.
Amendment 322 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the dataa summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.
Amendment 322 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 3
Article 23 – paragraph 3
3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the dataa summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.
Amendment 325 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourageinform and recommend the marketing authorisation holders of the possibility to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals. In this regard, to facilitate and foster the increased use of joint studies, the Agency shall oversee these in a cooridnating role, where necessary and appropriate.
Amendment 325 #
2023/0132(COD)
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourageinform and recommend the marketing authorisation holders of the possibility to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals. In this regard, to facilitate and foster the increased use of joint studies, the Agency shall oversee these in a cooridnating role, where necessary and appropriate.
Amendment 331 #
2023/0132(COD)
Proposal for a directive
Article 24 – paragraph 4
Article 24 – paragraph 4
4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within threewo years after entering into force of this Directive.
Amendment 331 #
2023/0132(COD)
Proposal for a directive
Article 24 – paragraph 4
Article 24 – paragraph 4
4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within threewo years after entering into force of this Directive.
Amendment 350 #
2023/0132(COD)
Proposal for a directive
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 350 #
2023/0132(COD)
Proposal for a directive
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 351 #
2023/0132(COD)
Proposal for a directive
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit of minimum 14 days for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.
Amendment 351 #
2023/0132(COD)
Proposal for a directive
Article 29 – paragraph 3
Article 29 – paragraph 3
3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit of minimum 14 days for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.
Amendment 352 #
2023/0132(COD)
Proposal for a directive
Article 29 – paragraph 4 – subparagraph 2
Article 29 – paragraph 4 – subparagraph 2
The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.
Amendment 352 #
2023/0132(COD)
Proposal for a directive
Article 29 – paragraph 4 – subparagraph 2
Article 29 – paragraph 4 – subparagraph 2
The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.
Amendment 353 #
2023/0132(COD)
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 353 #
2023/0132(COD)
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 356 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 356 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 3
Article 34 – paragraph 3
3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 359 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.
Amendment 359 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 4 – subparagraph 2
Article 34 – paragraph 4 – subparagraph 2
The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.
Amendment 360 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 5
Article 34 – paragraph 5
5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to recognise and enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 360 #
2023/0132(COD)
Proposal for a directive
Article 34 – paragraph 5
Article 34 – paragraph 5
5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to recognise and enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.
Amendment 361 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 361 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasonsshall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.
Amendment 363 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 363 #
2023/0132(COD)
Proposal for a directive
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;
Amendment 371 #
2023/0132(COD)
Proposal for a directive
Article 43 – paragraph 3
Article 43 – paragraph 3
3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1), as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.
Amendment 371 #
2023/0132(COD)
Proposal for a directive
Article 43 – paragraph 3
Article 43 – paragraph 3
3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1), as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.
Amendment 374 #
2023/0132(COD)
Proposal for a directive
Article 43 – paragraph 6
Article 43 – paragraph 6
6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 374 #
2023/0132(COD)
Proposal for a directive
Article 43 – paragraph 6
Article 43 – paragraph 6
6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.
Amendment 375 #
2023/0132(COD)
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which, on duly justified grounds described in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 375 #
2023/0132(COD)
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point g
Article 44 – paragraph 1 – subparagraph 1 – point g
(g) in case of medicinal products for which, on duly justified grounds described in the assessment report, there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post- authorisation obligation to substantiate the clinical benefit;
Amendment 379 #
2023/0132(COD)
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated or the reason for the imcomplete nature of the ERA are not duly justified or subtantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures by the applicant, in accordance Article 22 (3) this Directive;
Amendment 379 #
2023/0132(COD)
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated or the reason for the imcomplete nature of the ERA are not duly justified or subtantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures by the applicant, in accordance Article 22 (3) this Directive;
Amendment 386 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance whichor any of its ingredients or constituent parts are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile or listed in Annex X of Directive 2000/60/EC or Annex I of Directive 2006/118/EC for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.
Amendment 386 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 1 – point f
Article 51 – paragraph 1 – point f
(f) contains an active substance whichor any of its ingredients or constituent parts are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile or listed in Annex X of Directive 2000/60/EC or Annex I of Directive 2006/118/EC for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.
Amendment 387 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 387 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2
Article 51 – paragraph 2
2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.
Amendment 388 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.
Amendment 388 #
2023/0132(COD)
Proposal for a directive
Article 51 – paragraph 2 a (new)
Article 51 – paragraph 2 a (new)
2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.
Amendment 393 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1 a (new)
Article 56 – paragraph 3 – subparagraph 1 a (new)
For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State. Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products. When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.
Amendment 393 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1 a (new)
Article 56 – paragraph 3 – subparagraph 1 a (new)
For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State. Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products. When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.
Amendment 394 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 4
Article 56 – paragraph 4
4. The marketing authorisation holder shall, at all stages of manufacturing and distribution, within the limits of its responsability, ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.
Amendment 394 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 4
Article 56 – paragraph 4
4. The marketing authorisation holder shall, at all stages of manufacturing and distribution, within the limits of its responsability, ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.
Amendment 395 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 7
Article 56 – paragraph 7
7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate, in consultation with the competent authorities. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.
Amendment 395 #
2023/0132(COD)
Proposal for a directive
Article 56 – paragraph 7
Article 56 – paragraph 7
7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate, in consultation with the competent authorities. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.
Amendment 398 #
2023/0132(COD)
Proposal for a directive
Article 57 – title
Article 57 – title
Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products
Amendment 398 #
2023/0132(COD)
Proposal for a directive
Article 57 – title
Article 57 – title
Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products
Amendment 399 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded bodyforeign or european private entity, including philantropic entities, public authority or publicly funded body, including tax advantages and subsidies, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
Amendment 399 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct and indirect financial support received from any public authority or publicly funded bodyforeign or european private entity, including philantropic entities, public authority or publicly funded body, including tax advantages and subsidies, in relation to any activities for the research and development of the medicinal product covered by a national or a centralised marketing authorisation, irrespective of the legal entity that received that support.
Amendment 405 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall also report an estimate of the costs incurred for the research and development of the medicinal product covered by a national or a centralised marketing authorization.
Amendment 405 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
1 a. The marketing authorisation holder shall also report an estimate of the costs incurred for the research and development of the medicinal product covered by a national or a centralised marketing authorization.
Amendment 409 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or publicly funded bodentity that provided the financial support referred to in point (i);
Amendment 409 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 2 – point a – point ii
Article 57 – paragraph 2 – point a – point ii
(ii) the public authority or publicly funded bodentity that provided the financial support referred to in point (i);
Amendment 411 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)
Article 57 – paragraph 2 – point a – point iii a (new)
(iii a) any independent legal entity from which it obtained a license in relation to, or acquired, the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, as much as possible, include in the report information on any public or private funding received by the independent entity for its research activities in relation to the medicinal product.
Amendment 411 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii a (new)
Article 57 – paragraph 2 – point a – point iii a (new)
(iii a) any independent legal entity from which it obtained a license in relation to, or acquired, the medicinal product in its previous phases of development, and at which stage of the research and development process. The marketing authorisation holder shall, as much as possible, include in the report information on any public or private funding received by the independent entity for its research activities in relation to the medicinal product.
Amendment 413 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)
Article 57 – paragraph 2 – point a – point iii b (new)
(iii b) an estimate of the total costs incurred for the research and development of the medicinal product, which shall be disaggregated to each stage of drug research and development, including basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies.
Amendment 413 #
2023/0132(COD)
Proposal for a directive
Article 57 – paragraph 2 – point a – point iii b (new)
Article 57 – paragraph 2 – point a – point iii b (new)
(iii b) an estimate of the total costs incurred for the research and development of the medicinal product, which shall be disaggregated to each stage of drug research and development, including basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies.
Amendment 421 #
2023/0132(COD)
Proposal for a directive
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The marketing authorisation holder and it´s suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.
Amendment 421 #
2023/0132(COD)
Proposal for a directive
Article 58 – paragraph 4
Article 58 – paragraph 4
4. The marketing authorisation holder and it´s suppliers shall have in place systems and procedures to identify the other natural or legal persons to whom products referred to in paragraph 2 have been supplied. This information shall, upon request, be made available to the competent authorities.
Amendment 433 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decidshall ensure that the package leaflet ishall be made available in paper format orand electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packagi. Member States may choose to use only electronic leaflets for a limited range of a medicinal product. If the package leaflet is only made available electronically, thees dispensed to in-hospital patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patientwhere the provision of medical information will be ensured by health professionals.
Amendment 433 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decidshall ensure that the package leaflet ishall be made available in paper format orand electronically, or both. In the absence of such specific rules in a Member State, a package leaflet in paper format shall be included in the packagi. Member States may choose to use only electronic leaflets for a limited range of a medicinal product. If the package leaflet is only made available electronically, thees dispensed to in-hospital patient’s right to a printed copy of the package leaflet should be guaranteed upon request and free of charge and it should be ensured that the information in digital format is easily accessible to all patientwhere the provision of medical information will be ensured by health professionals.
Amendment 452 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the packagin order to progressively reduce the use of the paper format of the leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].
Amendment 452 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 by making mandatory the electronic version of the packagin order to progressively reduce the use of the paper format of the leaflet. That delegated act shall also establish the patient’s right to a printed copy of the package leaflet upon request and free of charge. The delegation of powers shall apply as of [OP please insert the date = five years following 18 months after the date of entering into force of this Directive].
Amendment 453 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. Member States shall implement this article after the publication of the Commissions implementing acts on the common standards for electronic versions of the package leaflet.
Amendment 453 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. The Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 214(2) to establish common standards for the electronic version of the package leaflet, the summary of product characteristics and the labelling, taking into account available technologies. Member States shall implement this article after the publication of the Commissions implementing acts on the common standards for electronic versions of the package leaflet.
Amendment 465 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes, including advertising and marketing activities.
Amendment 465 #
2023/0132(COD)
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Where the package leaflet is made available electronically, the individual right to privacy shall be ensured. Any technology giving access to the information shall ensure the protection of personal data in line with Regulation (EU) 2016/679 and Directive 2002/58/EC and not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes, including advertising and marketing activities.
Amendment 472 #
2023/0132(COD)
Proposal for a directive
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The package leaflet shall reflectIn addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [results of consultations with target patient groups to ensure that it is legible, clear and easy to usevised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in the aforementioned Article and followed by a standardised explanatory sentence that is appropriate, clearly legible, and easy to understand by users.
Amendment 472 #
2023/0132(COD)
Proposal for a directive
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The package leaflet shall reflectIn addition to the measures specified in paragraph 2, for medicinal products included in the list referred to in Article 112a of the [results of consultations with target patient groups to ensure that it is legible, clear and easy to usevised Regulation (EC) No 726/2004], the following additional statement shall be included ‘This medicinal product is subject to additional monitoring’. This statement shall be preceded by the symbol referred to in the aforementioned Article and followed by a standardised explanatory sentence that is appropriate, clearly legible, and easy to understand by users.
Amendment 485 #
2023/0132(COD)
Proposal for a directive
Article 69 – paragraph 1
Article 69 – paragraph 1
1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, including through medical sales representatives as referred to in Article 175(1), point (c), regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial- resistant pathogens, that may inform on the use of the antimicrobial. As referred to in paragraph 1 (b) of Article 17, the competent authority responsible for approving the antimicrobial shall review the content of the educational material and validate the final version.
Amendment 485 #
2023/0132(COD)
Proposal for a directive
Article 69 – paragraph 1
Article 69 – paragraph 1
1. The marketing authorisation holder shall ensure availability of educational material to healthcare professionals, including through medical sales representatives as referred to in Article 175(1), point (c), regarding the appropriate use of diagnostic tools, testing or other diagnostic approaches related to antimicrobial- resistant pathogens, that may inform on the use of the antimicrobial. As referred to in paragraph 1 (b) of Article 17, the competent authority responsible for approving the antimicrobial shall review the content of the educational material and validate the final version.
Amendment 487 #
2023/0132(COD)
Proposal for a directive
Article 69 – paragraph 2 – subparagraph 2
Article 69 – paragraph 2 – subparagraph 2
Member States may decidshall ensure that the awareness card ishall be made available in both in paper format orand electronically, or both. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.
Amendment 487 #
2023/0132(COD)
Proposal for a directive
Article 69 – paragraph 2 – subparagraph 2
Article 69 – paragraph 2 – subparagraph 2
Member States may decidshall ensure that the awareness card ishall be made available in both in paper format orand electronically, or both. In the absence of such specific rules in a Member State, an awareness card in paper format shall be included in the packaging of an antimicrobial.
Amendment 488 #
2023/0132(COD)
Proposal for a directive
Article 69 – paragraph 3
Article 69 – paragraph 3
3. The text of the awareness card shall be standarded by the Agency and shall be aligned with Annex VI.
Amendment 488 #
2023/0132(COD)
Proposal for a directive
Article 69 – paragraph 3
Article 69 – paragraph 3
3. The text of the awareness card shall be standarded by the Agency and shall be aligned with Annex VI.
Amendment 491 #
2023/0132(COD)
Proposal for a directive
Article 74 – paragraph 4
Article 74 – paragraph 4
4. TBased on any of the grounds listed in Article 75, the competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where thea medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketedWhen a competent authority grants an exemption to the language requirements that apply to the paper package leaflet, the patients’ right to a printed copy of the document in the official language or official languages of the Member State should be guaranteed upon request and free of charge.
Amendment 491 #
2023/0132(COD)
Proposal for a directive
Article 74 – paragraph 4
Article 74 – paragraph 4
4. TBased on any of the grounds listed in Article 75, the competent authorities of the Member State may also grant a full or partial exemption to the obligation that the labelling and the package leaflet must be in an official language or official languages of the Member State where thea medicinal product is placed on the market, as specified, for the purposes of this Directive, by that Member State. For the purpose of multi-language packages, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketedWhen a competent authority grants an exemption to the language requirements that apply to the paper package leaflet, the patients’ right to a printed copy of the document in the official language or official languages of the Member State should be guaranteed upon request and free of charge.
Amendment 496 #
2023/0132(COD)
Proposal for a directive
Article 80 – title
Article 80 – title
Regulatory data and, market protection and market exclusivity
Amendment 496 #
2023/0132(COD)
Proposal for a directive
Article 80 – title
Article 80 – title
Regulatory data and, market protection and market exclusivity
Amendment 497 #
2023/0132(COD)
Proposal for a directive
Article 80 – paragraph 2 a (new)
Article 80 – paragraph 2 a (new)
2 a. The period referred to in parragraph 2 shall be extended by an addittional period of one year, where the marketing authorization holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies. This extension may only be granted once.
Amendment 497 #
2023/0132(COD)
Proposal for a directive
Article 80 – paragraph 2 a (new)
Article 80 – paragraph 2 a (new)
2 a. The period referred to in parragraph 2 shall be extended by an addittional period of one year, where the marketing authorization holder obtains, during the data protection period referred to in Article 81, an authorisation for an additional therapeutic indication for which the marketing authorisation holder has demonstrated, with supporting data, a significant clinical benefit in comparison with existing therapies. This extension may only be granted once.
Amendment 498 #
2023/0132(COD)
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address asafeguard public health emergency, the data and market protection as well as the market exclusivity referred to in Article 71 of [revised Regulation (EC) No 726/2004], shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence. Relevant authorities in the Union shall also be able to reduce the duration of data protection, market protection, or market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate, where necessary to safeguard public health.
Amendment 498 #
2023/0132(COD)
Proposal for a directive
Article 80 – paragraph 4
Article 80 – paragraph 4
4. By way of derogation from the paragraphs 1 and 2, when a compulsory licence has been granted by a relevant authority in the Union to a party to address asafeguard public health emergency, the data and market protection as well as the market exclusivity referred to in Article 71 of [revised Regulation (EC) No 726/2004], shall be suspended with regard to that party insofar as the compulsory licence requires, and during the duration period of the compulsory licence. Relevant authorities in the Union shall also be able to reduce the duration of data protection, market protection, or market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate, where necessary to safeguard public health.
Amendment 507 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixfour years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.
Amendment 507 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixfour years from the date when the marketing authorisation for that medicinal product was granted in accordance with Article 6(2). For marketing authorisations that belong to the same global marketing authorisation the period of data protection shall start from the date when the initial marketing authorisation was granted in the Union.
Amendment 521 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)
(a a) 12 months, where the marketing authorisation holder demonstrates that the preclinical development of the medicinal product has been done within the Union as referred to in Article 82a;
Amendment 521 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)
Article 81 – paragraph 2 – subparagraph 1 – point a a (new)
(a a) 12 months, where the marketing authorisation holder demonstrates that the preclinical development of the medicinal product has been done within the Union as referred to in Article 82a;
Amendment 531 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d
Article 81 – paragraph 2 – subparagraph 1 – point d
Amendment 531 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point d
Article 81 – paragraph 2 – subparagraph 1 – point d
Amendment 541 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 3
Article 81 – paragraph 2 – subparagraph 3
Amendment 541 #
2023/0132(COD)
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 3
Article 81 – paragraph 2 – subparagraph 3
Amendment 552 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 1 – subparagraph 2
Article 82 – paragraph 1 – subparagraph 2
The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, as referred to in Chapter III, Section 3covering all the Member States entered into the decentralised procedure, as referred to in Chapter III, Section 3. The prolongation of the data protection period in regards medicinal products which obtained marketing authorisation in accordance with Articles 5 and 6 of [revised Regulation (EC) No 726/2004] as referred to in Article 81(2), first subparagraph, point (a), shall apply to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States concerned in which the marketing authorisation is valid.
Amendment 552 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 1 – subparagraph 2
Article 82 – paragraph 1 – subparagraph 2
The prolongation referred to in the first subparagraph shall apply to medicinal products that have been granted a centralised marketing authorisation, as referred to in Article 5 or that have been granted a national marketing authorisation through the decentralised procedure, as referred to in Chapter III, Section 3covering all the Member States entered into the decentralised procedure, as referred to in Chapter III, Section 3. The prolongation of the data protection period in regards medicinal products which obtained marketing authorisation in accordance with Articles 5 and 6 of [revised Regulation (EC) No 726/2004] as referred to in Article 81(2), first subparagraph, point (a), shall apply to medicinal products if they are released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States concerned in which the marketing authorisation is valid.
Amendment 555 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 2 – subparagraph 3 a (new)
Article 82 – paragraph 2 – subparagraph 3 a (new)
Where the conditions set out in paragraph 1 have not been fully satisified due to duly justified circumstances out of the control of the marketing authoristisation holder the Member State shall confirm the conditions in paragraph 1 have been satisified in their territory, subject to guarantee that these conditions will be fulfilled in an acceptable period of time agreed between the marketing authorisation holder and the Member State.
Amendment 555 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 2 – subparagraph 3 a (new)
Article 82 – paragraph 2 – subparagraph 3 a (new)
Where the conditions set out in paragraph 1 have not been fully satisified due to duly justified circumstances out of the control of the marketing authoristisation holder the Member State shall confirm the conditions in paragraph 1 have been satisified in their territory, subject to guarantee that these conditions will be fulfilled in an acceptable period of time agreed between the marketing authorisation holder and the Member State.
Amendment 556 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 2 – subparagraph 4
Article 82 – paragraph 2 – subparagraph 4
Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74[1] shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a). _________________ 74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusi, as long as the medicinal product is effectively con tin the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8)uously supplied on the market.
Amendment 556 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 2 – subparagraph 4
Article 82 – paragraph 2 – subparagraph 4
Positive decisions adopted in accordance with Articles 2 and 6 of Council Directive 89/105/EEC74[1] shall be considered equivalent to a confirmation referred to in the third subparagraph, point (a). _________________ 74 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusi, as long as the medicinal product is effectively con tin the scope of national health insurance systems (OJ L 40, 11.2.1989, p. 8)uously supplied on the market.
Amendment 563 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 5
Article 82 – paragraph 5
5. The Commission shall check the application referred to in paragraph 2, subparagraph 2, and grant approval or rejection to the prolongation referred to in Article 81(2). In those cases in which one or more Member States have issued a reasoned statement for refusal of the prolongation, the Commission shall ensure that the reasons described are justified and substantiated. The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC75 (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. _________________ 75 Council Decision of 20 May 1975 setting up a pharmaceutical committee (OJ L 147, 9.6.1975, p. 23).
Amendment 563 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 5
Article 82 – paragraph 5
5. The Commission shall check the application referred to in paragraph 2, subparagraph 2, and grant approval or rejection to the prolongation referred to in Article 81(2). In those cases in which one or more Member States have issued a reasoned statement for refusal of the prolongation, the Commission shall ensure that the reasons described are justified and substantiated. The Commission shall ensure that Marketing Authorisation Holders are not unduly prevented from receiving the incentives for actions beyond their control. Member States representatives may request the Commission to discuss issues related to the practical application of this Article in the Committee established by Council Decision 75/320/EEC75 (‘Pharmaceutical Committee’). The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee. _________________ 75 Council Decision of 20 May 1975 setting up a pharmaceutical committee (OJ L 147, 9.6.1975, p. 23).
Amendment 564 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 5 a (new)
Article 82 – paragraph 5 a (new)
5 a. The Commission shall make publicly available any information related to the decision taken on the grant or refusal of the prolongation of the data exclusivity period
Amendment 564 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 5 a (new)
Article 82 – paragraph 5 a (new)
5 a. The Commission shall make publicly available any information related to the decision taken on the grant or refusal of the prolongation of the data exclusivity period
Amendment 565 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 5 b (new)
Article 82 – paragraph 5 b (new)
5 b. Following the extension of the regulatory data protection as referred to in Article 81(2), the medicinal products should be released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid, for the entire duration of the protection time. Where the marketing authorisation holder fails to comply with this obligation, penalties should be established including the revocation of the extended regulatory protection period.
Amendment 565 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 5 b (new)
Article 82 – paragraph 5 b (new)
5 b. Following the extension of the regulatory data protection as referred to in Article 81(2), the medicinal products should be released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in the Member States in which the marketing authorisation is valid, for the entire duration of the protection time. Where the marketing authorisation holder fails to comply with this obligation, penalties should be established including the revocation of the extended regulatory protection period.
Amendment 568 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 6
Article 82 – paragraph 6
6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementingdelegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementingdelegated acts shall be adopted in accordance with the procedure referred to in Article 214(2)5.
Amendment 568 #
2023/0132(COD)
Proposal for a directive
Article 82 – paragraph 6
Article 82 – paragraph 6
6. The Commission, based on the experience of Member States and relevant stakeholders, may adopt implementingdelegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those implementingdelegated acts shall be adopted in accordance with the procedure referred to in Article 214(2)5.
Amendment 571 #
2023/0132(COD)
Proposal for a directive
Article 82 a (new)
Article 82 a (new)
Article82a Prolongation of the data protection period for medicinal products developed within the Union 1. A regulatory data protection period of one year shall be granted for a medicinal product if the marketing authorisation holder can demonstrate that its preclinical development was perfomed in the Union, even if another independent legal entity performed those studies, in initial stages of development, before the marketing authorisation holder acquired it. 2. One year after the date of entering into force of this Directive [OP please insert the date =12 months after the date of entering into force of this Directive], the Commission shall publish a study on the most adecuate indicators to evaluate that the provision in paragraph 1 is met. When performing the study, the Commission shall prioritize those indicators that could bring better outcomes for the promotion of research and development within the Union, specially that performed in SMEs. 3. The Commission shall adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. When setting up the conditions mentioned in paragraph 1, the Commission shall take into account the conclusions drawn from the study mentioned in paragraph 2.
Amendment 571 #
2023/0132(COD)
Proposal for a directive
Article 82 a (new)
Article 82 a (new)
Article82a Prolongation of the data protection period for medicinal products developed within the Union 1. A regulatory data protection period of one year shall be granted for a medicinal product if the marketing authorisation holder can demonstrate that its preclinical development was perfomed in the Union, even if another independent legal entity performed those studies, in initial stages of development, before the marketing authorisation holder acquired it. 2. One year after the date of entering into force of this Directive [OP please insert the date =12 months after the date of entering into force of this Directive], the Commission shall publish a study on the most adecuate indicators to evaluate that the provision in paragraph 1 is met. When performing the study, the Commission shall prioritize those indicators that could bring better outcomes for the promotion of research and development within the Union, specially that performed in SMEs. 3. The Commission shall adopt delegated measures relating to the procedural aspects outlined in this Article and regarding the conditions mentioned in paragraph 1. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 215. When setting up the conditions mentioned in paragraph 1, the Commission shall take into account the conclusions drawn from the study mentioned in paragraph 2.
Amendment 602 #
2023/0132(COD)
Proposal for a directive
Article 83 – paragraph 3
Article 83 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], and where relevant, representatives of patients’ organisations in the relevant disease areas, healthcare professionals, academics and experts.
Amendment 602 #
2023/0132(COD)
Proposal for a directive
Article 83 – paragraph 3
Article 83 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article it shall consult the Commission and the authorities or bodies referred to in Article 162 of [revised Regulation (EC) No 726/2004], and where relevant, representatives of patients’ organisations in the relevant disease areas, healthcare professionals, academics and experts.
Amendment 606 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo and a half years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
Amendment 606 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – introductory part
Article 84 – paragraph 1 – introductory part
1. A regulatory data protection period of fourtwo and a half years shall be granted for a medicinal product with respect to a new therapeutic indication not previously authorised in the Union, provided that:
Amendment 610 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out by the marketing authorisation applicant in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and
Amendment 610 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out by the marketing authorisation applicant in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, and
Amendment 620 #
2023/0132(COD)
Proposal for a directive
Article 84 a (new)
Article 84 a (new)
Article84a Reporting of research and development costs from the marketing authorisation holder 1.Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product. (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency. (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States. 3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.
Amendment 620 #
2023/0132(COD)
Proposal for a directive
Article 84 a (new)
Article 84 a (new)
Article84a Reporting of research and development costs from the marketing authorisation holder 1.Where the marketing authorisation holder benefits from data and market protection granted under this Directive it shall: (a) Upon request, submit to the Commission and/or the competent authorities of the Member States responsible for pricing and reimbursement an electronic report with detailed information on their expenditure in research and development activities related to the medicinal product. (b) make the report available within 30 days from the receipt of the request; (c) publish a summary of the report on the same webpage where the information described in Article 57 will be published. The link should be communicated to the competent authority of the Member State granting the marketing authorisation or, where appropriate, to the Agency. (d) ensure that the electronic report and lay summary are accurate and have been audited by an independent external auditor. 2. The Commission shall promote transparency and data sharing mechanisms regarding reimbursement prices of medicinal products by the Member States. 3. The Commission shall adopt delegated acts to lay down the methodology and format in which the information should be reported and published pursuant to paragraph 1.
Amendment 622 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 622 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is used for the purposes of:
Amendment 628 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, forfor the purpose of:
Amendment 628 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – introductory part
Article 85 – paragraph 1 – point a – introductory part
(a) studies, trials and other activities are conducted to generate data for an application, forfor the purpose of:
Amendment 636 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinalfor products and for subsequent variations;
Amendment 636 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinalfor products and for subsequent variations;
Amendment 640 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 647 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval;
Amendment 648 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) participating in public and private procurement tenders of medicinal products for which the fulfillment of the obligations laid out in the tender will commence after the expiry of the relevant patents or supplementary protection certificates;
Amendment 652 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirements necessary for the purpose of placing the medicinal product on the Union market or for export in third countries markets, after expiration of the patent or supplementary protection certificate.
Amendment 660 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
(b) the activities conducted exclusively for the purposes set out in point (a), mayshall cover the submission of the application for a marketing authorisation and the offering, manufacture, sale, supply, storage, import, export, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 669 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activities before expiry of relevant patent or supplementary protection certificates.
Amendment 672 #
2023/0132(COD)
Proposal for a directive
Article 85 a (new)
Article 85 a (new)
Article85a Prohibition on patent linkage 1. Member States shall not, when conducting regulatory or administrative procedures in regards to activities carried out in accordance with Article 85, enforce intellectual property rights as a valid ground for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids in regards to public and private procurement of medicinal products. 2. If the market authorization holder ceases to commercialise a medicinal product in the Union, the Commission shall have a public purchase option for all related intellectual property rights.
Amendment 677 #
2023/0132(COD)
Proposal for a directive
Article 86 a (new)
Article 86 a (new)
Article86a Measuring pharmaceutical access within the EU 1.The Commission, in collaboration with Member States, shall develop objective and specific indicators to measure pharmaceutical access within the EU. The indicators related to pharmaceutical access should include but not be limited to availability, health system and patient affordability and accesibility of medicines. (a) The Commission shall ensure that these indicators are evidence-based, measurable, and regularly reviewed to reflect the evolving healthcare landscape within the EU. Additionally, the Commission shall ensure that confidentiality of pricing and reimbursement data is overcome to avoid distorsion estimates. (b) The Commission, in collaboration with Member States, shall produce a quinquennial report on the state of pharmaceutical access within the Union. This report shall comprehensively analyse the indicators defined in paragraph 1, evaluating their effectiveness in gauging access to medicines. The Commission shall also establish a public database for annual update of paramenters defined in the quinquennial report.
Amendment 682 #
2023/0132(COD)
Proposal for a directive
Article 97 – paragraph 1 – point e a (new)
Article 97 – paragraph 1 – point e a (new)
(e a) facilitate harm reduction from adverse events through developing and implementing corrective patient safety plans for safe medicinal product administration and handling which can include the deployment of digital medication safety systems in hospitals and ambulatory care settings.
Amendment 684 #
2023/0132(COD)
Proposal for a directive
Article 104 – paragraph 2
Article 104 – paragraph 2
2. The marketing authorisation holder shall ensure that information to the public is presented objectively and is not misleading, and it is presented in a clear and adjusted language.
Amendment 686 #
2023/0132(COD)
Proposal for a directive
Article 105 – paragraph 2
Article 105 – paragraph 2
2. Marketing authorisation holders shall not refuse to consider reports of suspected adverse reactions received electronically or by any other appropriate means from patients, carers or other relevant persons, such as family members or healthcare professionals.
Amendment 688 #
2023/0132(COD)
Proposal for a directive
Article 106 – paragraph 1 – subparagraph 1
Article 106 – paragraph 1 – subparagraph 1
Each Member State shall record all suspected adverse reactions that occur in its territory and that are brought to its attention from healthcare professionals and patients. This shall include all authorised medicinal products and medicinal products used in accordance with Article 3, paragraphs 1 or 2. Member States shall involve patients and healthcare professionals, as appropriate, in the follow- up of any reports they receive in order to comply with Article 97(1), points (c) and (e), and shall seek to inform directly those stakeholders that reported a suspected adverse drug reaction on decisions taken in relation to the safety of the medicinal product.
Amendment 690 #
2023/0132(COD)
Proposal for a directive
Article 123 – paragraph 1 – point b
Article 123 – paragraph 1 – point b
(b) scientific guidance on post- authorisation efficacy studies, following the consultation process established under Article 162 of the [revised Regulation (EU) 726/2004].
Amendment 693 #
2023/0132(COD)
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point a a (new)
Article 147 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) maintain the market adequately supplied with the registered products, in an adequate and continuous maner, so that the needs of patients are covered;
Amendment 694 #
2023/0132(COD)
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point g
Article 147 – paragraph 1 – subparagraph 1 – point g
(g) use only active substances that have been manufactured in accordance with good manufacturing practice for active substances and distributed in accordance with good distribution practices for active substances, which include reliable, constant and timely delivery of the active substances to the manufacturing authorization holders;
Amendment 695 #
2023/0132(COD)
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)
Article 147 – paragraph 1 – subparagraph 1 – point j a (new)
(j a) comply with the risk mitigating measures in accordance with Article 22(4). In this regard, they shall comply and permit representatives of competent authorities of Member States to access their manufacturing premises, sites, and any outdoor facilities and effluents at any time. This obligation shall also apply where decentralised manufacturing or testing takes place.
Amendment 697 #
2023/0132(COD)
Proposal for a directive
Article 147 – paragraph 1 – subparagraph 3
Article 147 – paragraph 1 – subparagraph 3
For the purposes of points (f) and (g), manufacturing authorisation holders shall verify compliance, respectively, by the manufacturer or distributors of active substances with good manufacturing practice and good distribution practices by conducting audits at the manufacturing and distribution sites of the manufacturer and distributors of active substances. Manufacturing authorisation holders shall verify such compliance either by themselves or through an entity acting on their behalf under a contract. Manufacturing authorisation holders may diversify their contracts with manufacturer or distributors of active substances if needed to ensure an adequate, constant and timely provision to comply with their public service obligations for supply.
Amendment 698 #
2023/0132(COD)
Proposal for a directive
Article 148 – paragraph 8 – introductory part
Article 148 – paragraph 8 – introductory part
8. TIn order to ensure the smooth functioning of the decentralised sites with activities relevant for other Union legal frameworks, the competent authority of the Member State supervising the decentralised site pursuant to paragraph 4 shall cooperaterdinate their activities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts as regards the following:
Amendment 699 #
2023/0132(COD)
Proposal for a directive
Article 148 – paragraph 8 a (new)
Article 148 – paragraph 8 a (new)
8 a. The competent authorities referred to paragraph 8 shall guarantee that the modalitities of coordination shall not adversely affect the preparation of SoHO therapies on a Member State level.
Amendment 700 #
2023/0132(COD)
Proposal for a directive
Article 148 – paragraph 9
Article 148 – paragraph 9
9. Where relevant, competent authorities of the Member State supervising the central and decentralised sites mayshall liaise with the competent authority of the Member State responsible for the supervision of the marketing authorisation.
Amendment 703 #
2023/0132(COD)
Proposal for a directive
Article 160 – paragraph 1 – introductory part
Article 160 – paragraph 1 – introductory part
The Commission mayshall adopt implementing acts in accordance with Article 214(2) to supplement this Directive by specifying:
Amendment 704 #
2023/0132(COD)
Proposal for a directive
Article 160 – paragraph 1 – point b a (new)
Article 160 – paragraph 1 – point b a (new)
(b a) the principles and measures on reducing the environmental impact of medicinal products and active substances in manufacturing and distribution
Amendment 705 #
2023/0132(COD)
Proposal for a directive
Article 160 – paragraph 2
Article 160 – paragraph 2
Where relevant, these principles shall be specified in coherencealigned with with any principles of good practices established under any other Union legal framework.
Amendment 715 #
2023/0132(COD)
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriate and continued supplies of that medicinal product, in a sufficient quantity and a timely manner, to pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 718 #
2023/0132(COD)
Proposal for a directive
Article 172 – paragraph 1 – point a
Article 172 – paragraph 1 – point a
(a) the natural or legal person offering the medicinal products is authorised or entitled to supply medicinal products to the public, also at a distance, in accordance with national legislation of the Member State in which that person is established and in accordance with national legislation of the Member State to which the products are supplied;
Amendment 719 #
2023/0132(COD)
Proposal for a directive
Chapter XII a (new)
Chapter XII a (new)
XII a Chapter XII(a) Public procurement of medicinal products Article 174a Procurement of medicinal products 1. Member States may consider strategic approaches when engaging in procurement procedures, including criteria beyond price, in line with Directive 2014/24/EU on public procurement. When doing so they may put in place practices supporting security of supply and availability of medicines including: a) preliminary market consultation; b) awarding multiple contracts to reduce the risk of supply disruptions and mantain a competitive environment; c) increased use of “most economically advantageous tender” (MEAT) award criteria in public tenders, using qualitative criteira such as security of supply and production in the EU/EEA or in countries with which the EU has concluded an agreement on government procurement; (d) ensuring that the duration of contracts is tailored to favour predictability of demand and long-term availability. Article 174b Joint procurement of medicinal products 1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure with a view to the purchase of medicinal products. 2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a Joint Procurement Agreement between the parties determining the practical arrangements governing that procedure and the decision-making process with regard to the choice of the procedure, the joint procurement assessment as referred to in paragraph 3, point (c), the assessment of the tenders and the award of the contract. 3. The joint procurement procedure referred to in paragraph 1 of this Article shall comply with the following conditions: (a) participation in the joint procurement procedure is open to all Member States, European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046; (b) the rights and obligations of the countries referred to in point (a) that do not participate in the joint procurement are respected, in particular those relating to the protection and improvement of human health; (c) before the launch of a joint procurement procedure, the Commission prepares a joint procurement assessment which shall indicate the general envisaged conditions of the joint procurement procedure, including as regards possible restrictions to parallel procurement and negotiation activities by the participating countries for the medicinal product in question during the specific joint procurement procedure; that assessment shall take into account the need to ensure security of supply of medicinal products concerned to the participating countries. Based on the joint procurement assessment and the relevant information provided therein, such as on envisaged price ranges, manufacturers, delivery time frames and the proposed deadline for decision on participation, the parties to the Joint Procurement Agreement shall express their interest in participating at an early stage. Those parties to the Joint Procurement Agreement which have expressed their interest shall subsequently decide on their participation in the joint procurement procedure under the conditions jointly agreed with the Commission, taking into account the information proposed in the joint procurement assessment; (d) the joint procurement does not affect the internal market, does not constitute discrimination or a restriction of trade and does not cause distortion of competition; and (e) the joint procurement does not have any direct financial impact on the budget of the countries referred to in point (a) that do not participate in the joint procurement. 4. The Commission shall, in liaison with the Member States, ensure coordination and the exchange of information between the entities organising and participating in any action, including, but not limited to, joint procurement procedures for and development, stockpiling, distribution and donation of medicinal products, under different mechanisms established at Union level, in particular under: (a) stockpiling under rescEU referred to in Article 12 of Decision No 1313/2013/EU; (b) Regulation (EU) 2016/369; (c) the Pharmaceutical Strategy for Europe; (d) the EU4Health Programme established by Regulation (EU) 2021/522; (e) Regulation (EU) 2021/697 of the European Parliament and of the Council (34); and (f) other programmes and instruments supporting biomedical research and development at Union level for enhanced capacity and readiness to respond to cross-border threats and emergencies, such as measures adopted under Regulation (EU) 2022/2372. 5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of medicinal products and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001
Amendment 728 #
2023/0132(COD)
Proposal for a directive
Article 188 – paragraph 5 – introductory part
Article 188 – paragraph 5 – introductory part
5. Where the competent authority of the Member State, namely the supervisory authority, considers it necessary, in particular where there are grounds for suspecting non-compliance with the rules of this Directive, including with the principles of good manufacturing practice and good distribution practices, referred to in Articles 160 and 161, or based on a risk assesment, it may have its official representatives carry out the measures referred to in paragraph 1, second subparagraph at the premises or on the activities of:
Amendment 729 #
2023/0132(COD)
Proposal for a directive
Article 188 – paragraph 5 – point d
Article 188 – paragraph 5 – point d
(d) distributors of medicinal products or manufacturers or distributors of active substances located in third countries;
Amendment 738 #
2023/0132(COD)
Proposal for a directive
Article 200 – paragraph 4 – subparagraph 1
Article 200 – paragraph 4 – subparagraph 1
The competent authority of the Member State may process personal health data from sources other than clinical studies including the Eudravigilance database, electronic health data obtained pursuant to the applicable rules of the European Health Data Space to support their public health tasks and, in particular, the evaluation and monitoring to medicinal products, for the purpose of improving the robustness of the scientific assessment or verifying claims of the applicant or marketing authorisation holder. The competent authorities must put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including but not limited to clear and targeted data retention and deletion policies, state-of-the-art anonymisation and pseudonymisation requirements and techniques, confidentiality and data security measures, and access control mechanisms.
Amendment 741 #
2023/0132(COD)
Proposal for a directive
Article 201 – paragraph 2 a (new)
Article 201 – paragraph 2 a (new)
2 a. The Commission, in applying this Directive, in order to improve regulatory certainty and cross-sectoral cooperation it shall on an annual basis, or more frequently where deemed necessary, organise joint meetings between the Agency and the relevant advisory and regulatory bodies established under other Union legislation to assess emergeing trends and questions on the regulatory status of products and to find agreement on common regulatory status principles. The summaries and conclusions of these joint meetings shall be made publicly available, including the opinions and conclusions of each of the respective bodies.
Amendment 742 #
2023/0132(COD)
Proposal for a directive
Article 206 – paragraph 1 – subparagraph 1
Article 206 – paragraph 1 – subparagraph 1
Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties must be effective, proportionate and dissuasive. Member States shall, without delay, and taking into consideration the provision in paragraph 4, notify the Commission of those rules and of those measures and shall notify without delay of any subsequent amendment affecting them.
Amendment 743 #
2023/0132(COD)
Proposal for a directive
Article 206 – paragraph 2 – point d
Article 206 – paragraph 2 – point d
(d) non-compliance with the provisions laid down in this Directive on pharmacovigilance, and the provisions laid down in paragraph 2 of Article 17 in relation to the stewardship plan for antimicrobials, and in Article 44 on national marketing authorisations subject to conditions;
Amendment 745 #
2023/0132(COD)
Proposal for a directive
Article 206 – paragraph 3 a (new)
Article 206 – paragraph 3 a (new)
3 a. The European Commission shall lay down criteria for establishing the penalties, taking into account paragraphs 1, 2 and 3, and the highest penalties laid down amongst Member States before the application of this Directive.
Amendment 747 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1
Article 207 – paragraph 1
Member States shall ensure that appropriate collection systems are in place for medicinal products that are unused or have expired, and that the collected medicinal products are managed properly without any technically avoidable leakage to the environment.
Amendment 753 #
2023/0132(COD)
Proposal for a directive
Article 207 – paragraph 1 a (new)
Article 207 – paragraph 1 a (new)
By ... [18 months after the date of entry into force of this Directive], Member States shall draw up national plans including measures designed to: (a) monitor the rates of correct and incorrect disposal of unused and expired medicinal products; (b) inform the general public about the environmental risks associated with incorrect disposal of medicinal products, in particular those that contain substances referred to in Article 22(2); (c) inform healthcare professionals about the environmental risks associated with incorrect disposal of unused or expired medicinal products, in particular those that contain substances referred to in Article 22(2); (d) increase the rate of correct disposal of unused or expired medicinal products; and (e) designate public and private actors responsible for the collection systems referred to in paragraph 1.
Amendment 758 #
2023/0132(COD)
Proposal for a directive
Article 208 a (new)
Article 208 a (new)
Article208a Fostering research, innovation and production of medicinal products in the Union 1. The Commission shall establish an strategy to foster research, innovation and production of medicinal products in the Union, based on the results published in the report defined in paragraph 2. Member States shall be encouraged to participate in this strategy. 2. By... [one year after the date of entry into force of this Directive] the Commission shall present an impact assesment evaluating potential measures to be implemented at Union level, and at a Member State level to foster research, innovation and production of medicinal products in the Union. This report shall evaluate the effect of measures such as (a) funding and push and pull incentives directed to foster research and innovation in the Union, including public and private funding for preclinical and clinical research and innovation (b) public-private partnerships in research and innovation (c) regulatory support for public research and innovation entities (d) establishment of a public medicinal product production facility for products with low commertial interests (e) incentives for production inside the Union. Proposed measures shall be in line with developing a strategic autonomy for the Union regarding medicinal products.
Amendment 37 #
2023/0131(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) Ensuring that Europeans receive the medicines they need, when they need them, regardless of where they live in the EU is a central objective of the European Health Union. Boosting the competitiveness of the European pharmaceutical industry, whilst also ensuring better availability of medicines and more equal and timely access for patients is a key deliverable of the proposed EU pharmaceutical reform.
Amendment 41 #
2023/0131(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) The digital transformation of health and care will help increase the capacity of healthcare systems to deliver more personalised and effective health and care with less resource wasting. This regulation will contribute to the delivery of healthcare to European citizens, the design of health technologies and their manufacturing to be more sustainable by reducing energy consumption, waste, pollution and the release of harmful substances, including pharmaceuticals, into the environment.
Amendment 42 #
2023/0131(COD)
Proposal for a regulation
Recital 2 b (new)
Recital 2 b (new)
(2 b) It is of outmost importance to involve patients and healthy citizens, healthcare professionals, providers and payers, public health authorities and regulators, researchers or innovators from academia and industry - early in the knowledge generation or technology development process, including through patient and citizen engagement, community involvement or other forms of social innovation approaches, such that research and innovation activities are adjusted to the users’ particular expectations, needs, constraints and potential.
Amendment 45 #
2023/0131(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) Beyond cooperating along the value chain of knowledge and know-how production and valorisation or within the knowledge triangle (research-education- innovation), it is in the EU’s strategic interest to also reach out and cooperate with other countries outside the EU and on other continents. This applies in particular for multi-lateral cooperation on global health issues with countries associated to Horizon Europe but also with other partner countries and regions in the world. Involving international partners should lead to increased scientific knowledge and transfer of technology among partner countries allowing to address global health challenges across the world, thus creating sustainable growth and jobs.
Amendment 47 #
2023/0131(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) As to the scope of this Regulation, the authorisation of antimicrobials is, in principle, in the interest of patients' health at Union level and therefore it should be made possible to authorise them at Union level.
Amendment 49 #
2023/0131(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) Research in the pharmaceutical sector has a decisive role in alleviating patients’ conditions and improving public health. Favourable but balanced rules, facilitating innovation and sufficient protection to encourage such research, including through regulatory sandboxes, will contribute to make the EU markets more attractive and to promote the development of efficacious, safe, accessible, and affordable innovations for antimicrobial resistance, poverty-related and neglected diseases, and other conditions of global public health interest. Research and innovation should continue to ensure the highest standards in health products.
Amendment 61 #
2023/0131(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) To allow for a more informative decision making and for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency regarding medicinal products for human use, in particular to scientific guidelines on unmet medical needs and the design of clinical trials, or other studies and the generation of evidence along the life cycle of medicinal product, the Agency should be able to have recourse to a consultation process of authorities or bodies active along the life cycle of medicinal products. These authorities could be, as appropriate, representatives from Heads of Medicines Agencies, the Clinical Trial Coordination and Advisory Group, the SoHO Coordination Board, the Coordination Group on Health Technology Assessment, Medical Devices Coordination Group, medical devices national competent authorities, national competent authorities for pricing and reimbursement of medicines, national insurance funds or healthcare payers. The Agency should also be able to extend the consultation mechanism to consumers, patients, healthcare professionals, industry, associations representing payers, academia or other stakeholders, as relevant.
Amendment 63 #
2023/0131(COD)
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42 a) Beyond cooperating along the value chain of knowledge and know-how production and valorisation or within the knowledge triangle (research-education- innovation), it is in the EU’s strategic interest to also reach out and cooperate with other countries outside the EU. This applies in particular to multi-lateral cooperation on global health issues with countries associated to Horizon Europe but also with other partner countries and regions in the world. Involving international partners should lead to increased scientific knowledge and transfer of technology among partner countries allowing to address global health challenges across the world, thus creating sustainable growth and jobs.
Amendment 64 #
2023/0131(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) In the interest of public health, marketing authorisation decisions under the centralised procedure should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic and other considerations. However, Member States should be able, exceptionally, to prohibit the use in their territory of medicinal products for human useprovide due justification for such prohibition to the Agency.
Amendment 75 #
2023/0131(COD)
Proposal for a regulation
Recital 77 a (new)
Recital 77 a (new)
(77 a) The above mentioned market failures highlight the need for considering the establishment of a mission oriented R&D and manufacturing infrastructure at Union level which acts in the public interest. This initiative should be tasked to research and develop novel antimicrobials as well as other areas of unmet medical need, to respond to health threats and emergencies, to support the Union to overcome market failures, to conduct treatment optimisation studies and to prevent shortages and guarantee security of supply of critical medicinal products.
Amendment 80 #
2023/0131(COD)
Proposal for a regulation
Recital 79
Recital 79
Amendment 82 #
2023/0131(COD)
Proposal for a regulation
Recital 79 a (new)
Recital 79 a (new)
(79 a) In order to address the threat of antimicrobial resistance and its impact on public health and national healthcare budgets, the development and uptake of new economic models, pilot projects and push and pull incentives to boost the development of new therapies, diagnostics, antibiotics, medical devices and alternatives to using antimicrobials should be supported. Providing Member States with a toolkit of push and pull incentives will be decisive in tackling the growing negative impacts caused by antimicrobial resistance and will serve to address this market failure.
Amendment 83 #
2023/0131(COD)
Proposal for a regulation
Recital 80
Recital 80
Amendment 87 #
2023/0131(COD)
Proposal for a regulation
Recital 81
Recital 81
Amendment 88 #
2023/0131(COD)
Proposal for a regulation
Recital 82
Recital 82
Amendment 91 #
2023/0131(COD)
Proposal for a regulation
Recital 83
Recital 83
Amendment 92 #
2023/0131(COD)
Proposal for a regulation
Recital 84
Recital 84
Amendment 121 #
2023/0131(COD)
Proposal for a regulation
Recital 133
Recital 133
(133) Regulatory sandboxes can provide the opportunity for advancing regulation through proactive regulatory learning, enabling regulators to gain better regulatory knowledge and to find the best means to regulate innovations based on real-world evidence, especially at a very early stage of development of a medicinal product, which can be particularly important in the face of high uncertainty and disruptive challenges, as well as when preparing new policies. Regulatory sandboxes provide a structured context for experimentation, enable where appropriate in a real-world environment the testing of innovative technologies, products, services or approaches – at the moment especially in the context of digitalisation or the use of artificial intelligence and machine learning in the life cycle of medicinal products from drug discovery, development to the administration of medicinal products – for a limited time and in a limited part of a sector or area under strict regulatory supervision ensuring that appropriaterobust safeguards are in place. In its conclusions of 23 December 2020 the Council has encouraged the Commission to consider the use of regulatory sandboxes on a case- by-case basis when drafting and reviewing legislation.
Amendment 125 #
2023/0131(COD)
Proposal for a regulation
Recital 135
Recital 135
(135) The establishment of a regulatory sandbox should be based on a Commission Decision following a recommendation of the Agency. Such decision should be based on a detailed plan outlining the particularities of the sandbox as well as describing the products to be covered. A regulatory sandbox should be limited in duration and may be terminated at any time based on public health considerations. The learning stemming from a regulatory sandbox should inform future changes to the legal framework to fully integrate the particular innovative aspects into the medicinal product regulation. It is of utmost importance to ensure a harmonised implementation of these provisions across Member States. Where appropriate, adapted frameworks may be developed by the Commission on the basis of the results of a regulatory sandbox.
Amendment 131 #
2023/0131(COD)
Proposal for a regulation
Recital 137
Recital 137
(137) To achieve a better security of supply for medicinal products in the internal market and to contribute thereby to a high level of public health protection, it is appropriate to approximate the rules on monitoring and reporting of actual or potential shortages of medicinal products, including the procedures and the respective roles and obligations of concerned entities in this Regulation. It is important to ensure continued supply of medicinal products, which is often taken for granted across Europe. This is especially true for the most critical medicinal products which are essential to ensure the continuity of care, the provision of quality healthcare and guarantee a high level of public health protection in Europe. Member States should be able to introduce or maintain more robust measures to achieve security of supply for medicines than the safeguards provided for in this Regulation as long as these measures do not have a negative impact on the security of supply of other Member States.
Amendment 145 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 4
Article 2 – paragraph 2 – point 4
(4) ‘orphan medicineal products sponsor’ means any legal or natural person, established in the Union, who submitted an application for or has been granted an orphan designation by a decision referred to in Article 64(4);
Amendment 156 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 14 a (new)
Article 2 – paragraph 2 – point 14 a (new)
(14 a) ‘supply’ means the total volume of stock of a given medicinal product that is placed on the market by a marketing authorisation holder or a manufacturer;
Amendment 157 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 14 b (new)
Article 2 – paragraph 2 – point 14 b (new)
(14 b) ‘demand’ means the request for a medicinal product by a healthcare professional or patient in response to clinical the demand is satisfactorily met when the medicinal product is acquired in appropriate time and in sufficient quantity to allow continuity of provision of the best care to patients.
Amendment 170 #
2023/0131(COD)
Proposal for a regulation
Article 6 – paragraph 5 – subparagraph 2
Article 6 – paragraph 5 – subparagraph 2
The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.
Amendment 174 #
2023/0131(COD)
Proposal for a regulation
Article 8 – paragraph 1 – point b
Article 8 – paragraph 1 – point b
(b) identification and characterisation of hazards for the environment, animals and for human health; for the purpose of this point, ‘hazards for human health’ includes the risks to the health of human beings other than the treated patient as the risk to the treated patient shall be assessed as part of the benefit-risk assessment of the medicinal product;
Amendment 175 #
2023/0131(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. In case of first-in-class medicinal products or when a novel question is raised during the assessment of the submitted environmental risk assessment, the Committee for Medicinal Products for Human Use, or the rapporteur, shall carry out necessary consultations with bodies Member States have set up in accordance with Directive 2001/18/EC. They mayshall also consult with relevant Union bodies, inter alia the European Environment Agency. Details on the consultation procedure shall be published by the Agency at the latest by [OJ:12 months after the date of entry into force of this Regulation].
Amendment 179 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point m a (new)
Article 12 – paragraph 4 – point m a (new)
(m a) a stewardship plan in accordance with Article 17 of [revised Directive 2001/83/EC] and special information requirements in accordance with Article 69 of that Directive for any antimicrobials, as well as any other obligations imposed on the marketing authorisation holder;
Amendment 180 #
2023/0131(COD)
Proposal for a regulation
Article 12 – paragraph 4 – point m b (new)
Article 12 – paragraph 4 – point m b (new)
(m b) where applicable, a confirmation as to whether the medicinal product satisfies the criteria of Article 83 of [revised Directive 2001/83/EC] regarding medicinal products addressing an unmet medical need;
Amendment 181 #
2023/0131(COD)
Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 5
Article 13 – paragraph 1 – subparagraph 5
Where the draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences and make that information publicly available at the same time as the decision.
Amendment 185 #
2023/0131(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicantrisk mitigation measures proposed by the applicant in accordance with Article 22(3) of [revised Directive 2001/83/EC];
Amendment 190 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 1
Article 16 – paragraph 3 – subparagraph 2 – indent 1
– a summary of the assessment report written in a manner that is understandable to the public. The summary shall contain in particularthe complete environmental risk assessment submitted to the Agency by the marketing authorisation applicant as well as a summary of environmental risk assessment studies and their results as section relating to the conditions of use of the medicinal product;ubmitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency.
Amendment 191 #
2023/0131(COD)
Proposal for a regulation
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)
– for antimicrobials, all information referred to in Article 17 of and Annex I to [revised Directive 2001/83/EC] as well as any other obligations imposed on the marketing authorisation holder.
Amendment 192 #
2023/0131(COD)
Proposal for a regulation
Article 17 – paragraph 2 – subparagraph 4 a (new)
Article 17 – paragraph 2 – subparagraph 4 a (new)
Where post-authorisation studies to be performed in accordance with Article 20(1) justify it, the Commission may decide to withdraw a marketing authorisation for a medicinal product based on evidence pointing to a risk to public health.
Amendment 197 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 2
Article 19 – paragraph 1 – subparagraph 2
In emergency situations, as referred to in Article 2(1) of Regulation (EU) 2022/2371, a conditional marketing authorisation or a new conditional therapeutic indication referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.
Amendment 201 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit- risk balance is favour in accordance with Article 20, with a view to confirming the safety and efficacy of the medicinal product. The Agency shall make relevant deadlines and criteria for ongoing and new studies publicly available.
Amendment 202 #
2023/0131(COD)
Proposal for a regulation
Article 19 – paragraph 6
Article 19 – paragraph 6
6. By way of derogation from Article 17(1), an initial conditional marketing authorisation granted pursuant to this Article shall be valid for one year, on a renewable basis for the first three years after granting the authorisation and every two years thereafter. However, where the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) of Regulation (EU) 2022/2371, the marketing authorisation holder shall pursue a marketing authorisation in accordance with Article 5 of this Regulation.
Amendment 204 #
2023/0131(COD)
Proposal for a regulation
Article 19 a (new)
Article 19 a (new)
Article19a Revocation of conditional marketing authorisation The Commission may in justified cases revoke the conditional marketing authorisation that was granted in accordance with Article 19 where the benefit of the immediate availability of the medicinal product on the Union market no longer outweighs the risk due to missing confirming data or noncompliance with the obligations set out in Article 19.
Amendment 206 #
2023/0131(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2
Article 20 – paragraph 1 – subparagraph 2
If this obligation would apply to several medicinal products, the Agency shall encouraoblige the marketing authorisation holders concerned to conduct a joint post authorisation environmental risk assessment study.
Amendment 210 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f
Article 24 – paragraph 1 – subparagraph 2 – point f
(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder; in such cases, the Agency shall immediately inform the Commission who is to be responsible for informing the relevant national and Union authorities.
Amendment 212 #
2023/0131(COD)
Proposal for a regulation
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
Article 24 – paragraph 1 – subparagraph 2 – point f a (new)
(f a) commercial considerations
Amendment 238 #
2023/0131(COD)
Proposal for a regulation
Article 40
Article 40
Amendment 262 #
2023/0131(COD)
Proposal for a regulation
Article 40 a (new)
Article 40 a (new)
Article 40a Push and pull incentives scheme to boost the development of priority antimicrobials 1. The Commission shall establish a Union push and pull incentives scheme to promote and urgently accelerate the development of priority antimicrobials. Member States shall be encouraged to participate in the Union level scheme. 2. An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics: (a) it represents a new class of antimicrobials; (b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union; (c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection. In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or an equivalent list established at Union level 3. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding, which shall at least include the following incentives: (a) research grants under Union fund with conditionalities linked to the affordability and supply of new and existing antimicrobials; (b) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials; (c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales; (d) an annual revenue guarantee scheme, aimed at securing access to antibiotics in line with the 2021 Health Council Conclusions. 4. The Union push and pull incentives scheme shall be coordinated and managed by the Commission. provide information on all direct financial support received for research related to the development of the priority antimicrobial. 5. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of the Union push and pull incentives scheme. 5. By ... [six years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council reviewing the application of the scheme laid down in this Article.
Amendment 265 #
2023/0131(COD)
Proposal for a regulation
Article 41
Article 41
Amendment 271 #
2023/0131(COD)
Proposal for a regulation
Article 42
Article 42
Amendment 274 #
2023/0131(COD)
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
Amendment 320 #
2023/0131(COD)
Proposal for a regulation
Article 66 – paragraph 5
Article 66 – paragraph 5
5. At any time, an orphan designation may be withdrawn at the request of the orphan medicine sponsor. The orphan medicine sponsor shall provide a reasoned justification for the withdrawal request which shall be made publicly available.
Amendment 321 #
2023/0131(COD)
Proposal for a regulation
Article 67 – paragraph 3 – point f a (new)
Article 67 – paragraph 3 – point f a (new)
(f a) where applicable, any request made in accordance with Article 66(2) and any decisions taken in that respect.
Amendment 327 #
2023/0131(COD)
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and not-for-profit entities provided for in framework programmes for research and technological development.
Amendment 342 #
2023/0131(COD)
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Where the Agency adopts scientific guidelines for the application of this Article, it shall consult the Commission and, the authorities or bodies and other relevant stakeholders referred to in Article 162.
Amendment 343 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineeight years for orphan medicinal products other than those referred to in points (b), (ba) and (c);
Amendment 358 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point b a (new)
Article 71 – paragraph 2 – point b a (new)
(b a) five years for a new orphan therapeutic indication of medicinal products which have already received marketing authorisation in the Union ;
Amendment 362 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiveour years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].
Amendment 366 #
2023/0131(COD)
Proposal for a regulation
Article 71 – paragraph 2 a (new)
Article 71 – paragraph 2 a (new)
2 a. For the medicinal products referred to in paragraph 2, points (ba) and (c), the market exclusivity in respect of the orphan indication shall not prevent the entry of generic and biosimilar medicinal products on the market, provided that they are for other uses that are not subject to the market protection applicable in accordance with paragraph 2.
Amendment 395 #
2023/0131(COD)
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
4. Article 71(3) equally applies to the prolongations of market exclusivity referred to in paragraphs 1 and 2.
Amendment 410 #
2023/0131(COD)
Proposal for a regulation
Article 104 – paragraph 1 – subparagraph 1 – point c
Article 104 – paragraph 1 – subparagraph 1 – point c
(c) a summary of the risk management plans for medicinal products authorised in accordance with this Regulation and the accompanying summaries of the risk management plans;
Amendment 414 #
2023/0131(COD)
Proposal for a regulation
Article 113 – paragraph 1 a (new)
Article 113 – paragraph 1 a (new)
1 a. The creation of a regulatory sandbox is intended to fulfill the following objectives: a) improve legal certainty and contribute to the sharing of best practices in the field of emerging medicinal products and collecting information and data from marketing authorisation holders, developers, independent experts and researchers, and representatives of healthcare professionals and of patients through cooperation with the authorities involved in the sandbox with a view to ensuring compliance with this Regulation and, where appropriate, with other Union and Member States legislation; b) assisting prospective marketing authorization applicants in the experimentation and advancement of innovative medicinal products or product categories; c) contribute to evidence-based regulatory learning within a managed setting and identify possible future adaptations of the legal framework.
Amendment 423 #
2023/0131(COD)
Proposal for a regulation
Article 115 – paragraph 4
Article 115 – paragraph 4
4. The Agency with input from Member States shall submit annual reports to the Commission on the results from the implementation of a regulatory sandbox, including good practices, cases in which a regulatory sandbox had to be suspended or revoked as established in Article 113 (8), lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legal acts supervised within the sandbox. These reports shall be made publicly available by the Commission.
Amendment 424 #
2023/0131(COD)
Proposal for a regulation
Article 115 – paragraph 5 a (new)
Article 115 – paragraph 5 a (new)
5 a. By ... [12 months after the date of entry into force of this Regulation], in order to ensure a harmonised approach across Member States and support to the implementation of the regulatory sandboxes, the Commission, in consultation with the Agency, shall issue guidelines, without prejudice to other Union legislative acts. Where necessary, the guidelines should be updated to incorporate any relevant findings in the annual reports submitted by the Agency, as established in the fourth paragraph of this Article.
Amendment 435 #
2023/0131(COD)
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. TBy ... [12 months after the date of entry into force of this Regulation], the marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market and send it to the competent authority upon request. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 441 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 2
Article 118 – paragraph 1 – subparagraph 2
The Agency shall carry out that monitoring, in collaboration with the relevant competent authority of the Member State when those medicinal products are authorised under this Regulatioworking party referred to in Article 121(1) and after consultation with healthcare professionals and patient and consumer organisations, draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.
Amendment 443 #
2023/0131(COD)
Proposal for a regulation
Article 118 – paragraph 2
Article 118 – paragraph 2
2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned mayshall set a deadline for the submission of the information requested.
Amendment 445 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 1
Article 120 – paragraph 1
1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public mayshall report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State.
Amendment 446 #
2023/0131(COD)
Proposal for a regulation
Article 120 – paragraph 1 a (new)
Article 120 – paragraph 1 a (new)
1 a. For the purposes of the reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall transmit the information set out in Part Va of Annex IV to the competent authorities of the Member States in a timely manner.
Amendment 451 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 1 – point b
Article 121 – paragraph 1 – point b
(b) publish information on all expected or actual shortages of medicinal products, in cases in which that competent authority has assessed the shortagethe reason for the shortage, as well as measures taken to counter the expected or actual shortage, as soon as that competent authority has assessed the shortage and provide clear recommendations and possible alternatives to healthcare professionals and patients, on a publicly available and user-friendly website;
Amendment 455 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 2 – point f
Article 121 – paragraph 2 – point f
(f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level without undue delay.
Amendment 458 #
2023/0131(COD)
Proposal for a regulation
Article 121 – paragraph 5 – point a
Article 121 – paragraph 5 – point a
(a) report to the Agency on any information received from the marketing authorisation holder as defined in Article 116(1) of the medicinal product concerned or from other actors pursuant to Article 120(1a) and (2);
Amendment 462 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 4 – introductory part
Article 122 – paragraph 4 – introductory part
4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with the working party referred to in Article 121(1), point (c) and in consultation with relevant patient and consumer organisations:
Amendment 469 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 2 – subparagraph 2
Article 124 – paragraph 2 – subparagraph 2
For the purposes of this paragraph, the Agency mayshall set a deadline for the submission of the information requested.
Amendment 471 #
2023/0131(COD)
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available and user-friendly webpage that provides information on all actual critical shortages of medicinal products, in cases in which the Agency hascluding the reasons for the shortages. After assesseding the shortage and hass, the Agency shall provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).
Amendment 473 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point c
Article 125 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 123(4);
Amendment 474 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point f
Article 125 – paragraph 1 – point f
(f) inform the Agency of the end date of the critical shortage. without undue delay;
Amendment 475 #
2023/0131(COD)
Proposal for a regulation
Article 125 – paragraph 1 – point f a (new)
Article 125 – paragraph 1 – point f a (new)
(f a) inform the Agency of the cause of the critical shortage.
Amendment 478 #
2023/0131(COD)
Proposal for a regulation
Article 127 – paragraph 1
Article 127 – paragraph 1
1. The competent authority of the Member State shall, after consultation with healthcare professionals and national patient and consumer organisations, identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).
Amendment 484 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – introductory part
Article 130 – paragraph 1 – subparagraph 1 – introductory part
The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and after consultation with patient organisations, ensure the following:
Amendment 488 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilitithe therapeutic indication, vulnerabilities and the availability of appropriate alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, withith patient and consumer organisations, as well as other relevant stakeholders;
Amendment 493 #
2023/0131(COD)
Proposal for a regulation
Article 131 – paragraph 1
Article 131 – paragraph 1
1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), and patient and consumer organisations, as well as other relevant stakeholders as set out in Article 162 of this Regulation. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).
Amendment 495 #
2023/0131(COD)
Proposal for a regulation
Article 131 – paragraph 2
Article 131 – paragraph 2
2. The MSSG mayshall propose updates to the Union list of critical medicines to the Commission, where necessary.
Amendment 498 #
2023/0131(COD)
Proposal for a regulation
Article 133 – paragraph 1 – point c
Article 133 – paragraph 1 – point c
(c) take into accountcomply with the recommendations referred to in Article 132(1);
Amendment 499 #
2023/0131(COD)
Proposal for a regulation
Article 134 – paragraph 1 – introductory part
Article 134 – paragraph 1 – introductory part
1. The Commission may, where it considers it appropriate and necessaryshall:
Amendment 502 #
2023/0131(COD)
Proposal for a regulation
Article 134 a (new)
Article 134 a (new)
Article 134a General provisions 1. Member States may introduce or maintain more robust provisions than those provided for in this Regulation with regard to the security of supply of and the availability of medicinal products. These provisions should not have a negative impact on the security of supply and availability of medicinal products in other Member States. 2. The implementation of this Regulation shall in no circumstances constitute grounds for a reduction of the level of safeguards already afforded by Member States with regard to the security and availability of supply of medicinal products. Where Member States detect infringements of measures in relation to Chapter X, penalties in accordance with Article 171(1) shall be imposed without undue delay.
Amendment 503 #
2023/0131(COD)
Proposal for a regulation
Article 138 – paragraph 1 – subparagraph 2 – point ze
Article 138 – paragraph 1 – subparagraph 2 – point ze
(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, and where possible prioritising replacement strategies such for example as non-animal in vitro and silico approaches, taking into account the specificities of the assessment of medicinal products;
Amendment 517 #
2023/0131(COD)
Proposal for a regulation
Article 153 – paragraph 1
Article 153 – paragraph 1
At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. Guidelines for the determination of added therapeutic value shall be drawn up in collaboration with patient organisations and healthcare professionals.
Amendment 526 #
2023/0131(COD)
Proposal for a regulation
Article 175 – paragraph 2
Article 175 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 3(5), 19(8), 21, 40a, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4) and 172(10) shall be conferred on the Commission for a period of five years from [date of entry into force]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
Amendment 529 #
2023/0131(COD)
Proposal for a regulation
Annex II – point 25 a (new)
Annex II – point 25 a (new)
(25 a) the obligation to notify the competent authority of the Member State and, where relevant, the Agency about cessation, withdrawal, temporary suspension or temporary disruption in accordance with the deadlines provided for in Article 116;
Amendment 530 #
2023/0131(COD)
Proposal for a regulation
Annex II – point 25 b (new)
Annex II – point 25 b (new)
(25 b) the obligation to have in place and keep up to date a shortage prevention plan as provided for in Article 117;
Amendment 531 #
2023/0131(COD)
Proposal for a regulation
Annex II – point 25 c (new)
Annex II – point 25 c (new)
(25 c) the obligation to comply with the recommendations and measures taken in case of a critical shortage as provided for in Article 125;
Amendment 532 #
2023/0131(COD)
Proposal for a regulation
Annex II – point 25 d (new)
Annex II – point 25 d (new)
(25 d) the obligation to comply with the recommendations and measures taken in relation to critical medicinal products as provided for in Article 133.
Amendment 533 #
2023/0131(COD)
Proposal for a regulation
Annex IV – Part III – paragraph 1 – point 2 – point e
Annex IV – Part III – paragraph 1 – point 2 – point e
(e) Reason for shortage; including information on; (i) Raw material disruption, due to… (ii ) API disruption, due to… (iii) Excipient disruption, due to… (iv) Production problem, due to.. (v) Quality problem, due to… (vi) Production capacity, due to… (vii) Logistics problem, due to… (viii) Distribution problem, due to… (ix) Inventory and storage practices (x) Increase in demand (xi) Commercial reasons
Amendment 535 #
2023/0131(COD)
Proposal for a regulation
Annex IV – Part V a (new)
Annex IV – Part V a (new)
V a For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner: 1. Product availability information: Product availabilities shall be reported per wholesale warehouse and shall be indexed as yes/no. 2. Service level information: Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level.
Amendment 98 #
2023/0085(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Climate-related claims have been shown to be particularly prone to being unclear and ambiguous and to mislead consumers. This relates notably to environmental claims that products or entities are “climate neutral”, “carbon neutral”, “100% CO2 compensated”, or will be “net-zero” by a given year, or similar. Such statements are oft, which try to apply global carbon neutrality at a company or product level, are scientifically invalid when based on “offsetting” of greenhouse gas emissions through “carbon credits” generated outside the company’s value chain, for example from forestry or renewable energy projects. The methodologies underpinning offsecarbon credits vary widely and are not always transparent, accurate, or consistent. This leads to significant risks of overestimations and double counting of avoided or reduced emissions, due to a lack of additionality, permanence, ambitious and dynamic crediting baselines that depart from business as usual, and accurate accounting. These factors result in offsetcarbon credits of low environmental integrity and credibility that mislead consumers when they are relied upon in explicit environmental claims. Offsetting can deter consumers from more sustainable products and traders and can also deter traders from emissions reductions in their own operations and value chains. In order to adequately contribute to global climate change mitigation targets, traders should prioritiseimplement effective reductions of nearly all emissions across their own operations and value chains, instead of relying on offsetsting. Any resulting residual emissions will vary by sector-specific pathway in line with the global climate targets and will have to be addressed through removals enhancements. When offsets are used nonetheless, it is deemed appropriate to address climate- related claims, including claims on future environmental performance, based on offsets in a transparent manner. Therefore, the substantiation of climate- related claims should consider any greenhouse gas emissions offsets used by the traders separately from the trader’s or the product’s greenhouse gas emissions. In addition, this information should also specify the share of total emissions that are addressed through offsetting, whether these offsets relate to emission reductions or removals enhancement, and the methodology applied. The climate-related claims that include the use of offsets have to be substantiated by methodologies that ensure the integrity and correct accounting of these offsets and thus reflect coherently and transparently the resulting impact on the climateon a global level through carbon removals enhancements. Therefore, the substantiation of climate- related claims should not be based on greenhouse gas emissions offsets.
Amendment 106 #
2023/0085(COD)
Proposal for a directive
Recital 26 a (new)
Recital 26 a (new)
(26 a) Widely recognised scientific evidence indicates that the assessment of a claim should be based on methodologies, approaches or studies that have been developed in line with best practices in terms of transparency and independently peer reviewed by the scientific community, published in scientific journals.
Amendment 119 #
2023/0085(COD)
Proposal for a directive
Recital 31
Recital 31
(31) In order to meet both the needs of traders regarding dynamic marketing strategies and the needs of consumers regarding more detailed, and more accurate, environmental information, the Commission may adopt delegated acts to supplement the provisions on substantiation of explicit environmental claims by further specifying the criteria for such substantiation with regard to certain claims (e.g. climate-related claims, including claims about offsets, “climate neutrality”the transition in line with climate or other environmental goals, or similar, recyclability and recycled content). The Commission should be empowered to further establish rules for measuring and calculating the environmental impacts, environmental aspects and environmental performance, by determining which activities, processes, materials, emissions or use of a product or trader contribute significantly or cannot contribute to the relevant environmental impacts and environmental aspects; by determining for which environmental aspects and environmental impacts primary information should be used; and by determining the criteria to assess the accuracy of primary and secondary information. While in most cases the Commission would consider the need for adopting these rules only after having the results of the monitoring of the evolution of environmental claims on the Union market, for some types of claims it may be necessary for the Commission to adopt supplementary rules before the results of this monitoring are available. For example, in case of climate-related claims it may be necessary to adopt such supplementary acts in order to operationalise the provisions on substantiation of claims based on offsets.
Amendment 123 #
2023/0085(COD)
Proposal for a directive
Recital 32
Recital 32
(32) The Commission Recommendation (EU) 2021/2279 contains guidance on how to measure the life cycle environmental performance of specific products or organisations and how to develop Product Environmental Footprint Category Rules (PEFCRs) and Organisation Environmental Footprint Sectorial Rules (OEFSRs) that allow comparison of products to a benchmark. Such category rules for specific products or traders can be used to support the substantiation of claims in line with the requirements of this Directive. Therefore, the Commission should be empowered to adopt delegated acts to establish product group or sector specific rules where this may have added value. However, in case the Product Environmental Footprint method does not yet cover an impact category, which is relevant for a product group, the adoption of PEFCR may take place only once these new relevant environmental impact categories have been added. For example, as regards marine fisheries, the PEFCR should for example reflect the fisheries- specific environmental impact categories, in particular the sustainability of the targeted stock. Concerning space, the PEFCR should reflect defence and space- specific environmental impact categories, including the orbital space use. As regards food and agricultural products, biodiversity and naturIn order to include the new Green Claims Forum, the Commission should revise the Recommendation (EU) 2021/2279 to enable the Forum to contribute to PEFCR and OEFCR. The revision should specify minimum timelines for the provision of comments by the Green Claims Forum, and minimum rules for the publication of opinions to ensure a transparent process. In case the pProtection, as well as farming practices, including positive externalities of extensive farming and animal welfare, should, for example, also be integrated before the adoption of PEFCR could be considered. As regards textiles, the PEFCR should for exampleduct Environmental Footprint method does not yet cover an impact category, which is relevant for a product group, the adoption of PEFCR may take place only once these new reflect the microplastics release, before the adoption of PEFCR could be considervant environmental impact categories have been added.
Amendment 134 #
2023/0085(COD)
Proposal for a directive
Recital 35
Recital 35
(35) In order to facilitate consumers’ choices of more sustainable products and to incentivise efforts of traders to lower their environmental impacts, when the claim communicated relates to future environmental performance, it should as a priority be based on improvements, for example deep internal decarbonisation, inside a trader’s own operations and value chains rather than relying on the offsetting of greenhouse hgas emissions or other environmental impacts.
Amendment 140 #
2023/0085(COD)
Proposal for a directive
Recital 40 a (new)
Recital 40 a (new)
(40 a) In cases where a trader or trader's product is awarded an environmental label by a verified and certified environmental labelling scheme, the trader can use the verified environmental label in commercial communications based on the certificate of conformity obtained by the certification scheme. The trader can also make environmental claims based on the environmental aspects, impacts and performance of products certified by the verified label without having to apply for further verification. In that case, the information to be displayed should be that of the environmental labelling scheme, including the certificate of conformity.
Amendment 153 #
2023/0085(COD)
Proposal for a directive
Recital 47 a (new)
Recital 47 a (new)
(47 a) Regular revisions of environmental labelling schemes are of fundamental importance in order to ensure their continuous improvement. In line with its objective of increasing the level of environmental protection and contributing to accelerating the green transition towards a circular, clean and climate neutral economy in the Union, this Directive ensures that the verification and certification of the substantiation and communication of environmental labelling schemes ensure their continuous improvement.
Amendment 161 #
2023/0085(COD)
Proposal for a directive
Recital 52
Recital 52
(52) In order to provide traders with legal certainty across the internal market as regards compliance of the explicit environmental claims with the requirements of this Directive, the certificate of conformity should be recognised by the competent authorities across the Union. Microenterprises should be allowed to request suchThe certificate iof they wish to certify their claims in line with the requirements of this Directive and benefit from the certificate’s recognition across the Union. The certificate of conformity should however not prejudgeconformity should however not prejudge, is not relevant for, and shall not be relied upon for the assessment of the environmental claim by the public authorities or courts, which enforce Directive 2005/29/EC. This Directive requires that the substantiation of explicit environmental claims shall be based on an assessment that meets selected minimum criteria to help prevent such claims from being misleading.
Amendment 163 #
2023/0085(COD)
Proposal for a directive
Recital 53
Recital 53
(53) In order to ensure uniform conditions for the provisions on verification of explicit environmental claims and environmental labelling schemes and to facilitate the enforcement of the provisions on verification of this Directive, implementing powers should be conferred on the Commission to adopt a common form for certificates of conformity and the technical means for issuing such certificates. This common form should facilitate the recognition of certificates of conformity by the competent authorities across the Union. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council86 . _________________ 86 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 168 #
2023/0085(COD)
Proposal for a directive
Recital 54
Recital 54
(54) SMicro, small and medium-sized enterprises (SMEs) should be able to benefit from the opportunities provided by the market for more sustainable products but they could face proportionately higher costs and difficulties with some of the requirements on substantiation and verification of explicit environmental claims. The Member States shouldand the Commission should, in their respective areas of responsibility, provide adequate information and raise awareness of the ways to comply with the requirements of this Directive, ensure targeted and specialised training, and provide specific assistance and support, including financial, to micro enterprises and SMEs wishing to make explicit environmental claims on their products or as regards their activities. Member States actions should be taken in respectshould develop a tool that facilitates the substantiation of apexplicable State aid ruleit environmental claims.
Amendment 194 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 2 – introductory part
Article 1 – paragraph 2 – introductory part
2. This Directive does not apply to environmental labelling schemes or, to explicit environmental claims regulated by or substantiated and verified by rules established in :
Amendment 221 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 2 – point p
Article 1 – paragraph 2 – point p
Amendment 226 #
2023/0085(COD)
Proposal for a directive
Article 1 – paragraph 2 a (new)
Article 1 – paragraph 2 a (new)
2 a. By way of derogation from the second paragraph of this article, this Directive continues to apply if the legislation listed in points (a) to (o) of paragraph 2 does not provide an equivalent level of protection with respect to the substantiation, communication, verification and enforcement of this Directive. Within one year after entry into force of this Directive the Commission shall adopt a Delegated Act including the list of all environmental claims which are either fully excluded from the scope or for which only specific articles will apply.
Amendment 256 #
2023/0085(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8
Article 2 – paragraph 1 – point 8
(8) ‘environmental label’ means a sustainability label covering only or predominantlany environmental aspects of a product, a process or a trader;
Amendment 277 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
1. Member States shall ensure that traders carry out an assessment to substantiate explicit environmental claims in the form in which they will be displayed. This assessment shall:
Amendment 281 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) specify if the claim is related to the whole product, part of a product or certain aspects or part of the life cycle of a product, part or to all activities of a trader or a certain part or aspect of these activities, as relevant to the claim;
Amendment 290 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) rely on robust, independent, verifiable and widely recognised scientific evidence, use accurate information and which takes into account relevant international standarupdated scientific findings and methods;.
Amendment 299 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point c
Article 3 – paragraph 1 – point c
(c) demonstrate that environmental impacts, environmental aspects or environmental performance that are subject to the claim are significant from a life- cycle perspective; and market perspective and, for claims about traders, from an entire business perspective, including with respect to environmental aspects or impacts which are not addressed, or only to a limited extent, by life cycle assessment methods.
Amendment 311 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point d
Article 3 – paragraph 1 – point d
(d) where a claim is made on environmental performance, take into account all environmental aspects or environmental impacts that are subject to the claim, which are significant to assessing the environmental performance;.
Amendment 336 #
2023/0085(COD)
(g) identify whether improving environmental impacts, environmental aspects or environmental performance subject to the claim leads to significant harm in relation to environmental impacts on climate change, resource consumption and circularity, sustainable use and protection of water and marine resources, pollution, biodiversity, animal welfare and ecosystems;
Amendment 341 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point h
Article 3 – paragraph 1 – point h
(h) separate any greenhouse gas emissions offsets used from greenhouse gas emissions as additional environmental information, specify whether those offsets relate to emission reductions or removals, and describe how the offsets relied upon are of high integrity and accounted for correctly to reflect the claimed impact on climateprovide information demonstrating that no greenhouse gas emissions offsets are used for the claim;
Amendment 356 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) iInclude primary information available to the trader for environmental impacts, environmental aspects or environmental performance, which are subject to the claim;. Primary information shall be included for environmental aspects which contribute significantly to the environmental performance of the product or trader, in particular, product composition, processes, materials and energy used in the production, emissions from the processes, impacts on biotic resources, the use of the product, its durability, and reparability, and end of life aspects.
Amendment 360 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 1 – point j
Article 3 – paragraph 1 – point j
(j) include relevaas a supplement secondary information for environmental impacts, environmental aspects, or environmental performance which is representative of the specific value chain of the product or the trader on which a claim is made, in cases where no primary information is available. Where secondary information is used, a justification must be given demonstrating why primary information is not available to the trader.
Amendment 376 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2 a. Within 12 months from the entry into force of this Directive, the European Commission shall publish and regularly update the list of methodologies that are compliant with Article 3. This shall include also methodologies verified in line with Article 10, paragraph 2, point b.
Amendment 379 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 3
Article 3 – paragraph 3
Amendment 399 #
2023/0085(COD)
4 a. By ... [1 year from the date of entry into force of this Directive], the Commission shall identify the most common explicit environmental claims made on the Union market and publish a list of claims that the Commission intends to supplement with the delegated act referred to in paragraph 4. That list shall be updated every 3 years.
Amendment 411 #
2023/0085(COD)
Proposal for a directive
Article 3 – paragraph 5 a (new)
Article 3 – paragraph 5 a (new)
5 a. Within one year after entry into force of this Directive, the Commission will present a work plan with a prioritisation of specific claims for which the absence of clear requirements for their substantiation and communication might lead to misleading claims and necessitates the development of further requirements through delegated acts, in accordance with Article 18 and with consultation of stakeholders through the Green Claims Consultation Forum. This work plan will be regularly revised and updated to take account of the regular monitoring of environmental claims referred to in Article 20.
Amendment 438 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Member States shall ensure that a trader, including online marketplaces, is required to communicate an explicit environmental claim in accordance with the requirements set out in this Article.
Amendment 442 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Explicit environmental claims may only cover environmental impacts, environmental aspects or environmental performance that are substantiated in accordance with the requirements laid down in Articles 3, 4 and 5 and that are identified as significant for the product or trader concerned in accordance with Article 3 paragraph (1) point (c) or (d). This does not apply to explicit environmental claims based on specific requirements from an environmental labelling scheme, which have been verified and obtained a certificate of conformity according to Article 10(2). Such claims can be communicated without needing to be subject to additional verification in accordance with Article 10(1).
Amendment 448 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Where the explicit environmental claim is related to future environmental performance of a product or trader it shall include a time-bound, science based and measurable commitment for improvements inside own operations and value chains, set out in a publicly available detailed and realistic implementation plan, including comprehensive information on concrete and verifiable interim targets accompanied with monitoring and reporting plans. The plans shall be regularly verified by an independent third-party expert, whose findings shall be made publicly available.
Amendment 456 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4 a. Explicit environmental claims shall be prohibited for products containing substances or preparations/mixtures meeting the criteria for classification as toxic, hazardous to the environment, carcinogenic, mutagenic or toxic for reproduction (CMR), causing endocrine disruption to human health or the environment, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), or very persistent, very mobile (vPvM) properties in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, nor to goods containing substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, except when their use is considered essential for society.
Amendment 457 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 4 b (new)
Article 5 – paragraph 4 b (new)
4 b. Explicit environmental claims based on greenhouse gas emissions offsetting which claim that a product has a neutral, reduced or positive impact on the environment in terms of greenhouse gas emissions, shall be prohibited.
Amendment 465 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 1
Article 5 – paragraph 6 – subparagraph 1
Information on the product or the trader that is the subject of the explicit environmental claim and on the substantiation shall be made available together with the claim in a physical form or in the form of a weblink, QR code or equivalent. For claims based on an environmental labelling scheme which have obtained a certificate of conformity, following verification in accordance with Article 10(2), the label itself is sufficient information.
Amendment 483 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point c
Article 5 – paragraph 6 – subparagraph 2 – point c
(c) the underlying studies, including the assessment referred to in Article 3, or calculations used to assess, measure and monitor the environmental impacts, environmental aspects or environmental performance covered by the claim, without omitting the results of such studies or calculations and, explanations of their scope, assumptions and limitations, unless the information is a trade secret in line with Article 2 paragraph 1 of Directive (EU) 2016/943112 ; _________________ 112 Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
Amendment 492 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point f
Article 5 – paragraph 6 – subparagraph 2 – point f
(f) for climate-related explicit environmental claims that rely on greenhouse gas emission offsets, informaate to carbon credits or other contributions to which extent they rely on offsets andenvironmental projects whether these relate to emissions reductions or removals of emissions or other environmental impacts;
Amendment 499 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 6 – subparagraph 2 – point g a (new)
Article 5 – paragraph 6 – subparagraph 2 – point g a (new)
(g a) when a sustainability label is based on different levels of performance, the existing classes must be clearly provided in the same visual representation together with the level that the product, process or business has been assigned to. Further information on the definition of classes must be provided.
Amendment 544 #
2023/0085(COD)
Proposal for a directive
Article 8 – paragraph 2 – point f a (new)
Article 8 – paragraph 2 – point f a (new)
(f a) the environmental labelling scheme regularly reviews its objectives, its strategies, and the performance of its tools and system, based on the latest best practices, scientific data and evidence. When the review finds improvements are possible, the scheme updates its underlying requirements in order to reflect technical developments and raise the ambition.
Amendment 595 #
2023/0085(COD)
Proposal for a directive
Article 8 – paragraph 7
Article 8 – paragraph 7
7. The Commission shall publish and keep-up-to date a list of officially recognised environmental labels that are environmental labelling schemes that comply with this Directive and are allowed to be used on the Union market after [OP: Please insert the date = the date of transposition of this Directive] pursuant to paragraphs 3, 4 and 5.
Amendment 625 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 3 a (new)
Article 10 – paragraph 3 a (new)
Amendment 636 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The verification shall be undertaken and completed within a reasonable timeframe, as defined in delegated acts referred to in Article 8(8), by a verifier fulfilling the requirements set out in Article 11, in accordance with the procedures referred to in paragraphs 1 and 2, before the environmental claim is made public or the environmental label is displayed by a trader.
Amendment 651 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 7
Article 10 – paragraph 7
7. The certificate of conformity shall be recognised by the competent authorities responsible for the application and enforcement of this Directive. Member States shall notify the list of certificates of conformity via the Internal Market Information System established by Regulation (EU) No 1024/2012. All certificates of conformity shall be made available on a searchable public database clearly identifying the key information including the name of the trader, the type of claim, the assessment methodology and the sector.
Amendment 657 #
2023/0085(COD)
Proposal for a directive
Article 10 – paragraph 8
Article 10 – paragraph 8
8. The certificate of conformity shall not prejudge, is irrelevant to and shall not be relied upon for the assessment of the environmental claim by national authorities or courts in accordance with Directive 2005/29/EC.
Amendment 677 #
2023/0085(COD)
Proposal for a directive
Article 11 – paragraph 3 – point b
Article 11 – paragraph 3 – point b
(b) the verifier, its top-level management and the personnel responsible for carrying out the verification tasks shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to the verification activities, such as providing other services to the relevant trader(s);
Amendment 693 #
2023/0085(COD)
Proposal for a directive
Article 11 – paragraph 3 a (new)
Article 11 – paragraph 3 a (new)
3 a. Accredited verifiers established in one Member State in accordance with Regulation (EC) No 765/2008 may perform verification activities in any other Member State under the same conditions as accredited verifiers established in that Member State.
Amendment 699 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – introductory part
Article 12 – paragraph 1 – introductory part
Member States shall take appropriate measures to help micro, small and medium sized enterprises apply the requirements set out in this Directive. Those measures shall at least include guidelines or similar mechanisms to raise awareness of ways to comply with the requirements on explicit environmental claims. In addition, wWithout prejudice to applicable state aid rules, such measures may shall include:
Amendment 701 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – point a
Article 12 – paragraph 1 – point a
(a) financial supportguidelines or similar mechanisms to raise awareness of ways to comply with the requirements on explicit environmental claims;
Amendment 703 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) access to financefinancial support;
Amendment 704 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – point c
Article 12 – paragraph 1 – point c
(c) specialised management and staff trainingaccess to finance;
Amendment 705 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – point d
Article 12 – paragraph 1 – point d
(d) organisational and technical assistancespecialised management and staff training.
Amendment 707 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 – point d a (new)
Article 12 – paragraph 1 – point d a (new)
(d a) organisational and technical assistance.
Amendment 710 #
2023/0085(COD)
Proposal for a directive
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
Member States shall designate single points of contact for microenterprises and SMEs from where they can request information on complying with the requirements on explicit environmental claims and on the available support referred to in the previous subparagraph.
Amendment 718 #
2023/0085(COD)
Proposal for a directive
Article 13 – paragraph 2
Article 13 – paragraph 2
2. For the purpose of the enforcement of Articles 5 and 6, Member States may designate the national authorities or courts responsible for the enforcement of Directive 2005/29/EC. In that case, Member States may derogate fromshall also apply the enforcement rules adopted in accordance with Articles 141 to 173 of this Directive and apply the enforcement rules adopted2005/29/EC. Member states shall ensure that consumers harmed by non- compliance with this Directive have access to proportionate and effective remedies in accordance with Articles 11 to 13a of Directive 2005/29/EC.
Amendment 735 #
2023/0085(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. Natural or legal persons or organisations regarded under Union or national law as having a legitimate interest shall be entitled to submit substantiated complaints to competent authorities when they deem, on the basis of objective circumstances, that a tradthat one or more traders or verifiers is failing to comply with the provisions of this Directive.
Amendment 737 #
2023/0085(COD)
Proposal for a directive
Article 16 – paragraph 3
Article 16 – paragraph 3
3. Competent authorities shall, without undue delay, diligently and impartially assess the substantiated complaint referred to in paragraph 1 and, where necessary, take the necessary steps, including inspections and hearings of the person or organisation, with a view totraders and verifiers concerned, with a view to detecting potential breaches of the provisions of this Directive verify those complaints. If confirmed, the competent authorities shall take the necessary actions in accordance with Article 15.
Amendment 742 #
2023/0085(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Competent authorities shall, as soon as possible and in any case in accordance with the relevant provisions ofwithin 30 days of receiving a substantiated concern, if not otherwise stated in national law, inform the person or organisation referred to in paragraph 1 that submitted the complaint of its decision to accede to or refuse the request for action put forward in the complaint and shall provide the reasons for it, and a description of the further steps and measures it will take. Competent authorities may allow for additional information to be provided by the person who has submitted the concern.
Amendment 778 #
2023/0085(COD)
Proposal for a directive
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1 a. ‘Green Claims Forum’ is the expert group which the European Commission will establish to ensure a balanced participation of Member States’ representatives and all interested parties implicated in secondary legislation for green claims in question, such as industry, including SMEs and craft industry, trade unions, traders, retailers, importers, environmental labelling schemes, environmental protection groups and consumer organisations. The Commission shall consult the Green Claims Forum in the process of evaluating and updating requirements for the substantiation of environmental claims. The Green Claims Forum shall provide opinion on whether existing rules and methods are fit for the purpose of substantiating specific environmental claims, and provide recommendations on the revision or the development of new delegated acts. The Green Claims Forum shall contribute in particular to preparing Delegated Acts with respect to Article 3 (4) and provide recommendations on how to communicate environmental aspects and impacts to consumers.
Amendment 819 #
2023/0085(COD)
Proposal for a directive
Article 25 – paragraph 1 a (new)
Article 25 – paragraph 1 a (new)
1 a. Environmental labelling schemes existing on the market prior to the date of application of this Directive, can continue to operate while the verification process in accordance with Article 8(5) is concluded.