Activities of Pernille WEISS related to 2023/0132(COD)
Reports (1)
REPORT on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
Amendments (196)
Amendment 24 #
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, and create an attractive environment for research, development and production of medicines in the Union while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, 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; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.
Amendment 34 #
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11 a) This Directive should be consistent with the Union’s objectives with regard to promotion of research, innovation and industrial competitiveness, including with regard to a globally competitive system of intellectual property (IP) incentives. The provisions of this Directive should be coordinated with the Union’s industrial and digital strategies as well as its trade policy to ensure that the Union is capable of competing with challenger regions, as highlighted by the resolution of the European Parliament of 24 November 2021 on a pharmaceutical strategy for Europe1a. Likewise, the conclusions of the Council of 23 March 2023 on competitiveness, single market and the economy have stressed the importance of strengthening incentives for investments in innovation. In that regard, it should be considered how the European life science sector, including the pharmaceutical industry, contributes as a whole to meeting those objectives and thus how this Directive should work to support it. _________________ 1a OJ C 224, 8.6.2022, p. 47.
Amendment 40 #
Proposal for a directive
Recital 12
Recital 12
(12) The definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products and to address potential regulatory gaps, without changing the overall scope or affecting national competences in this regard, such as for pricing and reimbursement procedures, due to scientific and technological developments, e.g. low- volume products, bedside-manufacturing or personalised medicinal products that do not involve an industrial manufacturing process.
Amendment 43 #
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17 a) Member States should take measures to promote the availability of medicinal products derived from substances of human origin and together with the Commission strengthen EU open strategic autonomy with regard to plasma for fractionation intended for plasma- derived medicinal products.
Amendment 45 #
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 49 #
Proposal for a directive
Recital 18 a (new)
Recital 18 a (new)
(18 a) The Agency should establish a programme with the objective to guide academic and other not-for-profit entities through the centralised marketing authorisation procedure. That programme should be able to draw on results of the European Medicines Agency (EMA) pilot programme for enhanced support to academic and non-profit developers of advanced therapy medicinal products, started in September 2022.
Amendment 51 #
Proposal for a directive
Recital 19
Recital 19
(19) This Directive should be without prejudice to the provisions of Council Directive 2013/59/Euratom41 , including with respect to justification and optimisation of protection of patients and other individuals subject to medical exposure to ionising radiation. In the case of radiopharmaceuticals used for therapy, marketing authorisations, posology and administration rules have to notably respect that Directive’s requirements that exposures of target volumes are to be individually planned, and their delivery appropriately verified taking into account that doses to non-target volumes and tissues are to be as low as reasonably achievable and consistent with the intended therapeutic purpose of the exposure.. _________________ 41 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
Amendment 52 #
Proposal for a directive
Recital 26
Recital 26
(26) In order to reward the compliance with all the measures included in the agreed paediatric investigation plan, for products covered by a supplementary protection certificate, if relevant information on the results of the studies conducted is included in the product information, a reward should be granted in the form of a six monthn extension of the supplementary protection certificate created by [Regulation (EC) No 469/2009 of the European Parliament and of the Council42 - OP please replace reference by new instrument when adopted]. _________________ 42 Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (OJ L 152, 16.6.2009, p. 10).
Amendment 59 #
Proposal for a directive
Recital 46 a (new)
Recital 46 a (new)
(46 a) Member States apply diverse procedures and measures in the pricing and reimbursement of medicinal products. Those procedures and measures significantly affect access to medicinal products, especially with regard to the speed at which access is achieved. Likewise, Member States apply specific procedures and measures pertaining to the promotion of competition from generic and biosimilar medicinal products. Having regard to the competence of the Member States, and recognising the disparities which can be observed in access to medicines across the Union, the exchange of best practice among national competent authorities in that area should be given greater priority. In that regard, the Commission should play a distinct role in facilitating the exchange of best practices.
Amendment 60 #
Proposal for a directive
Recital 47
Recital 47
(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection for market launch shall take place in the 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.
Amendment 63 #
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases.In the event of joint procurement of medicinal products as a medical countermeasure in cases of serious cross- border threats to health, the provisions of Regulation (EU) 2022/2371 of the European Parliament and of the Council49a apply. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 71 #
Proposal for a directive
Recital 50
Recital 50
(50) The establishment of a criteria- based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, 'quality of life', ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The Agency should also seek input from other relevant stakeholders. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.
Amendment 73 #
Proposal for a directive
Recital 50 a (new)
Recital 50 a (new)
(50 a) The development of medical products in underserved therapeutic areas can greatly increase the quality of life for patients. In that regard, elements such as acute or chronic side effects, in particular in relation to the toxicity of a product, as well as the ability of patients to perform regular life activities, the presence of pain and the management of co-morbidities should be considered in the assessment of improving quality of life. Improving quality of life can allow patients to return to job or education, which can not only bear a significant positive effect on the individual patient, but can also alleviate costs to society arising from productivity losses. Furthermore, novel medicinal products which have significant positive impacts on the quality of life of a patient can also alleviate the burden on family and carers, in particular as regards paediatric patients. This will in turn also have a societal impact in areas such as labour shortages and fiscal budgets.
Amendment 80 #
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.
Amendment 83 #
Proposal for a directive
Recital 53
Recital 53
(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not.
Amendment 87 #
Proposal for a directive
Recital 54
Recital 54
(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to marketsubmit an application for pricing and reimbursement for a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory data protection, and where a Member State has requested it.
Amendment 89 #
Proposal for a directive
Recital 55
Recital 55
(55) When applying the provisions on market launch incentives, mMarketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.
Amendment 90 #
Proposal for a directive
Recital 56
Recital 56
Amendment 94 #
Proposal for a directive
Recital 58
Recital 58
(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. Equally, to promote faster and wider access to medicines, it is critical that the timelines set out in that Directive are respected in negotiations between applicants and Member States, and that negotiations are conducted in good faith.
Amendment 96 #
Proposal for a directive
Recital 58 a (new)
Recital 58 a (new)
(58 a) Cross-border healthcare is an important pathway for patients to access medicinal products that might otherwise not be available to them. To support access to medicinal products, in particular in the case of small patient populations or where the administration of a medicine requires special competences or infrastructure, the full implementation of Directive 2011/24/EU of the European Parliament and of the Council1a should be supported. It is important to consider in that regard all alternative paths of making available medicinal products to patients and prescribing doctors, such as named patient supply, administering of medicine via a centre of excellence, early access or compassionate use programs, and other cross-border healthcare. Competent authorities of the Member States should therefore utilise the NCAPR to exchange and share best practice regarding the implementation of cross-border access agreements and negotiations. _________________ 1a Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 99 #
Proposal for a directive
Recital 59
Recital 59
Amendment 102 #
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 a 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 the crisis. For this reason, data and market protection should be suspended for the indication that is relevant to the public health emergency when a compulsory licence has been issued to tackle a 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 106 #
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 and only in the relevant Member States. A ‘suspension‘ of data and market protection in cases of 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 112 #
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 requirements necessary to obtain regulatory 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 considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and 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 confined to conduct studies and trials and other activities needed for the regulatory approval process, and health technology assessment and pricing reimbursement request, even though 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 process.
Amendment 120 #
Proposal for a directive
Recital 64
Recital 64
(64) It will allow, inter alia, to conduct studies to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.
Amendment 135 #
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. 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, it should be possible to refuse the marketing authorisation should be refused. The ERA should be updated when new data or knowledge about relevant risks become available.
Amendment 139 #
Proposal for a directive
Recital 72
Recital 72
(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless 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. At the date of adoption of this Directive, there is not a scientifically agreed method to set regulatory values for the contribution of manufacturing to antimicrobial resistance other than for antibiotic resistance. The Commission should therefore issue guidelines on how to conduct ERAs for AMR selection for microbials other than bacteria after consulting the EMA, the European Centre for Disease Prevention and Control (ECDC) and the European Environment Agency.
Amendment 149 #
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 and cell and gene therapies, 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 of a certification scheme also for additional master files, including 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, as well as for raw materials and starting materials used for manufacturing of cell therapy and gene therapy.
Amendment 158 #
Proposal for a directive
Recital 124
Recital 124
(124) Rules should be laid down as to how the labelling and package leaflets are to be presented. The package leaflet should be easily legible, clearly comprehensible and indelible by users, including especially the target patient groups. Patient leaflets are in the category of consultative reading which means that relevant information should be found without reading the whole leaflet. For readability and legibility, the package leaflet can benefit from a typographic hierarchy and a legible typeface. Design choices should serve function and readability, rather than aesthetics, and secondarily consider the environmental sustainability of the leaflet.
Amendment 167 #
Proposal for a directive
Recital 131
Recital 131
(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public 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 financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any public authority or public body of the Union to carry out any activities for the research and development of medicinal products.
Amendment 171 #
Proposal for a directive
Recital 12
Recital 12
(12) The definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products and to address potential regulatory gaps, without changing the overall scope or affecting national competences in this regard, such as for pricing and reimbursement procedures, due to scientific and technological developments, e.g. low- volume products, bedside-manufacturing or personalised medicinal products that do not involve an industrial manufacturing process.
Amendment 171 #
Proposal for a directive
Recital 149
Recital 149
(149) In order to supplement or amend certain non-essential elements of this Directive, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of specifying the procedure for examination of application of active substance master file certificate, the publication of such certificates, the procedure for changes to the active substance master file and its certificate, access to the active substance master file and its assessment report; specifying additional quality master files to provide information on a constituent of a medicinal product, the procedure for examination of application of a quality master file certificate or a platform technology master file certificate, the publication of such certificates, the procedure for changes to the quality master file and its certificate, and access to the quality master file and its assessment report; determining the situations in which post-authorisation efficacy studies may be required; specifying the categories of medicinal products to which a marketing authorisation subject to specific obligations could be granted and specifying the procedures and requirements for granting such a marketing authorisation and for its renewal; specifying exemptions to variation and the categories in which variations should be classified and establishing procedures for the examination of applications for variations to the terms of marketing authorisations as well as specifying conditions and procedures for cooperation with third countries and international organisations for examination of applications for such variations. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert 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-Making67 . 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. _________________ 67 OJ L 123, 12.5.2016, p. 1.
Amendment 179 #
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17 a) Member States should take measures to promote the availability of medicinal products derived from substances of human origin and together with the Commission strengthen EU open strategic autonomy with regard to plasma for fractionation intended for plasma- derived medicinal products.
Amendment 180 #
Proposal for a directive
Article 2 – paragraph 1 a (new)
Article 2 – paragraph 1 a (new)
1 a. 1a. For the purpose of this Article, ‘non-routine basis’ means an advanced therapy medicinal product prepared under hospital exemption on an incidental and exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product available,nor an ongoing relevant clinical trial or compassionate use programme for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union. The following measures shall be an indication that an activity occurs on a routine basis: (a) the manufacturing of a product using standardised or repetitive processes; or (b) the use of processes that involve planning in advance, beyond what is needed to address the immediate clinical needs of individual patients.
Amendment 181 #
Proposal for a directive
Article 2 – paragraph 2 – subparagraph 1
Article 2 – paragraph 2 – subparagraph 1
The manufacturing of an advanced therapy medicinal product prepared under hospital exemption shall require an approval by the competent authority of the Member State (‘hospital exemption approval’). Member States shall notify any such approval, as well as subsequent changes, to the Agency which shall publish such approval in the repository referred to in paragraph 6. The hospital exemption approval shall be valid for a period of 12 months.
Amendment 183 #
Proposal for a directive
Article 2 – paragraph 2 – subparagraph 2
Article 2 – paragraph 2 – subparagraph 2
The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. The application shall include evidence on quality, safety and efficacy of the advanced therapy medicinal products prepared under hospital exemption. Before a hospital exemption approval is granted, the competent authority of the Member State shall confirm that no advanced therapy medicinal product is authorised within the Union for the same therapeutic indication, and that the manufacturing of such medicinal product complies with the requirements for preparation on a non-routine basis as set out in paragraph 1.
Amendment 187 #
Proposal for a directive
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption, as well as any relevant data from patient follow-up, 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 3.
Amendment 191 #
Proposal for a directive
Article 2 – paragraph 5
Article 2 – paragraph 5
5. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.
Amendment 195 #
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, quality, 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 publicly accessible repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, which shall be updated regularly.
Amendment 198 #
Proposal for a directive
Article 2 – paragraph 7 – subparagraph 1 – point d
Article 2 – paragraph 7 – subparagraph 1 – point d
Amendment 204 #
Proposal for a directive
Article 2 – paragraph 8
Article 2 – paragraph 8
8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The report shall be made publicly available. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter.
Amendment 208 #
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
Amendment 211 #
Proposal for a directive
Article 4 – paragraph 1 – point 2 – point d
Article 4 – paragraph 1 – point 2 – point d
(d) chemical, e.g. elements, including radioactive isotopes thereof (radionuclides), naturally occurring chemical materials and chemical products obtained by chemical change or synthesis;
Amendment 212 #
Proposal for a directive
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
(4) ‘starting material’ means any material, including radioactive materials, from which an active substance is manufactured or extracted;
Amendment 213 #
Proposal for a directive
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4 a) ‘plasma for fractionation’ means the liquid part of human blood separated from whole blood or collected by apheresis and intended to be used as the starting material for manufacture of plasma-derived medicinal products;
Amendment 215 #
Proposal for a directive
Article 4 – paragraph 1 – point 18
Article 4 – paragraph 1 – point 18
(18) ‘radiopharmaceutical’ means any medicinal product that, when ready for use, contains one or morea radioactive component and that is intended to treat or diagnose a disease, including radionuclides ( radioactive isotopes) included for a medicinal purposepharmaceuticals and complex radiopharmaceuticals, not including radionuclides used only for radiolabelling purposes, medical devices and in-vitro diagnostic devices;
Amendment 216 #
Proposal for a directive
Article 4 – paragraph 1 – point 18 a (new)
Article 4 – paragraph 1 – point 18 a (new)
(18 a) 'radionuclide radiopharmaceuticals' means a radiopharmaceutical where the radionuclide or its salt is the active substance;
Amendment 217 #
Proposal for a directive
Article 4 – paragraph 1 – point 18 b (new)
Article 4 – paragraph 1 – point 18 b (new)
(18 b) 'complex radiopharmaceutical' means a radiopharmaceutical where the radionuclide is bound to or within a carrier molecule to achieve the targeted accumulation, including ready-to-use dosage forms and kits for radiopharmaceutical preparation;
Amendment 218 #
Proposal for a directive
Article 4 – paragraph 1 – point 19
Article 4 – paragraph 1 – point 19
(19) ‘radionuclide generator’ means any system incorporating a fixed parent radionuclide from which is produced a daughter radionuclide which is to be obtained by elution or by any other method and used in a radiopharmaceuticala daughter radionuclide is produced, where the daughter radionuclide is used either as a medicinal product or as a radionuclide for radiolabelling purposes;
Amendment 219 #
Proposal for a directive
Article 4 – paragraph 1 – point 20
Article 4 – paragraph 1 – point 20
(20) ‘kit’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration for radiopharmaceutical preparation’ means a pre-formulated medicinal product containing all ingredients required to directly prepare a radiopharmaceutical, with the exception of the radionuclide;
Amendment 220 #
Proposal for a directive
Article 4 – paragraph 1 – point 21
Article 4 – paragraph 1 – point 21
Amendment 222 #
Proposal for a directive
Article 4 – paragraph 1 – point 26
Article 4 – paragraph 1 – point 26
(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulations (EU) 2017/745 and (EU) 2017/746) and where the two are intended for use in the given combination in accordance with the summary of product characteristics;
Amendment 224 #
Proposal for a directive
Article 4 – paragraph 1 – point 28
Article 4 – paragraph 1 – point 28
(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response for prevention, including post exposure prophylaxis, and for treatment of diseases caused by an infectious agent;
Amendment 226 #
Proposal for a directive
Article 4 – paragraph 1 – point 30 a (new)
Article 4 – paragraph 1 – point 30 a (new)
(30 a) ‘platform technology’ means a technology or collection of technologies used in the manufacturing process, quality control, or testing of medicinal products or their components that rely on prior knowledge and are established under the same underlying scientific principles;
Amendment 227 #
Proposal for a directive
Article 4 – paragraph 1 – point 30 b (new)
Article 4 – paragraph 1 – point 30 b (new)
(30 b) ‘platform technology master file’ means a document, prepared by the owner of the platform technology, that contains data of a platform technology for which the underlying scientific principles, under which the platform technology is established, will apply regardless of components added to the platform as part of the manufacturing process for a medicinal product;
Amendment 228 #
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 potential risks to the environment, orincluding risks to public health arising from risks to the environment, posed by the release of the medicinal product in the environment from the use 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 237 #
Proposal for a directive
Article 4 – paragraph 1 – point 53
Article 4 – paragraph 1 – point 53
(53) ‘micro, small and medium-sized enterprises’ means micro, small and medium-sized enterprises as defined in Article 2 of Commission Recommendation 2003/361/EC72 ; and, from ... [18 months after the date of entry into force of this Directive], it means micro, small and medium-sized enterprises as defined in the delegated act referred to in Article 58a(1); _________________ 72 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 239 #
Proposal for a directive
Article 4 – paragraph 1 – point 70
Article 4 – paragraph 1 – point 70
(70) ‘public service obligation’ means to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very shortreasonable time over the whole of the area in question.
Amendment 242 #
Proposal for a directive
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. A marketing authorisation may be granted for a medicinal product on the basis of an active substance master file, an additional quality master file or a platform technology master file.
Amendment 252 #
Proposal for a directive
Article 15 – title
Article 15 – title
Fixed dose combination medicinal product, platform technologies and multi-medicinal product packages
Amendment 253 #
Proposal for a directive
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Where justified for preventative or therapeutic purposes, a marketing authorisation may be granted for a fixed dose combination medicinal product.
Amendment 255 #
Proposal for a directive
Article 15 – paragraph 2 – subparagraph 1
Article 15 – paragraph 2 – subparagraph 1
Where justified for preventative or therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted for a medicinal product comprised of a fixed component and a variable component that is pre- defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients (‘platform technology’).
Amendment 260 #
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. A marketing authorisation shall be required for radionuclide generators, kits, and radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1)pharmaceuticals.
Amendment 263 #
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. A marketing authorisation shall not be required for radionuclides or radionuclide generators solely used for radiolabelling purposes, or for a radiopharmaceutical prepared at the time of use by an authorised person or by an establishment authorised, according to national legislation, to use such radiopharmaceutical in an approved healthcare establishment exclusively from authorised radionuclide generators, kitsusing an authorised kit for radiopharmaceutical preparation in combination with a radionuclide or radionuclide precursgenerators in accordance with the manufacturer's instructionssummary of product characteristics of the kit ('kit-radiolabelling').
Amendment 274 #
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 65, or provide the 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 279 #
Proposal for a directive
Article 22 – paragraph 2 – introductory part
Article 22 – paragraph 2 – introductory part
2. The ERA shall indicate whether the medicinal product or any of its ingredients or other constituents is classified according to one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:
Amendment 284 #
Proposal for a directive
Article 22 – paragraph 2 – subparagraph 1
Article 22 – paragraph 2 – subparagraph 1
Amendment 289 #
Proposal for a directive
Article 22 – paragraph 3
Article 22 – paragraph 3
3. TWhere the ERA identifies a risk to the environment, 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. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.
Amendment 296 #
Proposal for a directive
Article 22 – paragraph 4 – subparagraph 1 (new)
Article 22 – paragraph 4 – subparagraph 1 (new)
By way of derogation from the first subparagraph, the obligation to conduct a risk assessment for antimicrobial resistance shall only cover the risk for antibiotic resistance. That derogation shall cease to apply by ... [3 years after the date of entry into force of this Directive].
Amendment 297 #
Proposal for a directive
Article 22 – paragraph 4 a (new)
Article 22 – paragraph 4 a (new)
4 a. By ... [18 months after the date of entry into force of this Directive], the Commission shall, after having consulted the Agency, the European Environmental Agency (EEA), and the ECDC, issue guidelines on how to conduct the ERA for antimicrobials other than antibiotics.
Amendment 299 #
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. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and, the European Environmental Agency (EEA), the ECDC and other relevant stakeholders, including those managing residues from medicinal products and their production in the environment, on the drafting of these scientific guidelines.
Amendment 303 #
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 leads to a change of the conclusions of the ERA. 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, and environmental exposure data.
Amendment 303 #
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 leads to a change of the conclusions of the ERA. 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, and environmental exposure data.
Amendment 305 #
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. The competent authority may also request the marketing authorisation holder to include in the ERA risk mitigation measures provided for in paragraph 3.
Amendment 305 #
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. The competent authority may also request the marketing authorisation holder to include in the ERA risk mitigation measures provided for in paragraph 3.
Amendment 311 #
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. The outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, shall be made publicly available by the Agency or, as appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.
Amendment 311 #
Proposal for a directive
Article 22 – paragraph 7 a (new)
Article 22 – paragraph 7 a (new)
7 a. The outcome of the assessment of the ERA, including the data submitted by the marketing authorisation holder, shall be made publicly available by the Agency or, as appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.
Amendment 315 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 30 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 harmfulposing an unacceptable risk to the environment in accordance with paragraph 2.
Amendment 315 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
By [OP please insert the date = 30 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 harmfulposing an unacceptable risk to the environment in accordance with paragraph 2.
Amendment 317 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
This programme shall not exceed 10 years and shall be made publicly available by the Agency.
Amendment 317 #
Proposal for a directive
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
This programme shall not exceed 10 years and shall be made publicly available by the Agency.
Amendment 318 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmfulposing an unacceptable risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information, and may consult with relevant stakeholders including actors managing residues from medicinal products and their production in the environment, in particular water.
Amendment 318 #
Proposal for a directive
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmfulposing an unacceptable risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information, and may consult with relevant stakeholders including actors managing residues from medicinal products and their production in the environment, in particular water.
Amendment 329 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and data requested.
Amendment 329 #
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The setting-up of the system of ERA monographs shall be based on a risk- based prioritisation of active substances and data requested.
Amendment 330 #
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 three years after entering into force of this Directive, while taking into account outcomes from relevant Union initiatives, such as with regard to animal testing.
Amendment 330 #
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 three years after entering into force of this Directive, while taking into account outcomes from relevant Union initiatives, such as with regard to animal testing.
Amendment 332 #
Proposal for a directive
Article 24 – paragraph 5 – point e a (new)
Article 24 – paragraph 5 – point e a (new)
(e a) the risk-based prioritisation of data requirements for active substances, including to avoid unnecessary animal testing.
Amendment 332 #
Proposal for a directive
Article 24 – paragraph 5 – point e a (new)
Article 24 – paragraph 5 – point e a (new)
(e a) the risk-based prioritisation of data requirements for active substances, including to avoid unnecessary animal testing.
Amendment 333 #
Proposal for a directive
Article 25 – paragraph 2 – subparagraph 3
Article 25 – paragraph 2 – subparagraph 3
The Agency shall establish a repository of active substance master files, their assessments reports and their certificates and ensure that personal data and commercially sensitive information is protected. The Agency shall ensure that the competent authorities of the Member State have access to this repository.
Amendment 333 #
Proposal for a directive
Article 25 – paragraph 2 – subparagraph 3
Article 25 – paragraph 2 – subparagraph 3
The Agency shall establish a repository of active substance master files, their assessments reports and their certificates and ensure that personal data and commercially sensitive information is protected. The Agency shall ensure that the competent authorities of the Member State have access to this repository.
Amendment 334 #
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 1
Article 26 – paragraph 1 – subparagraph 1
Marketing authorisation applicants may, instead of submitting the relevant data on an active substance other than a chemical active substance, or on other substances present or used in the manufacture of a medicinal product, including raw materials and starting materials used for the manufacturing of cell therapies and gene therapies, required in accordance with Annex II, rely on an additional quality master file, an additional quality master file certificate granted by the Agency in accordance with this Article (‘additional quality master file certificate’), or a certificate confirming that the quality of that substance is suitably controlled by the relevant monograph of the European Pharmacopeia.
Amendment 334 #
Proposal for a directive
Article 26 – paragraph 1 – subparagraph 1
Article 26 – paragraph 1 – subparagraph 1
Marketing authorisation applicants may, instead of submitting the relevant data on an active substance other than a chemical active substance, or on other substances present or used in the manufacture of a medicinal product, including raw materials and starting materials used for the manufacturing of cell therapies and gene therapies, required in accordance with Annex II, rely on an additional quality master file, an additional quality master file certificate granted by the Agency in accordance with this Article (‘additional quality master file certificate’), or a certificate confirming that the quality of that substance is suitably controlled by the relevant monograph of the European Pharmacopeia.
Amendment 339 #
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance present or used in the manufacture of a medicinal product, including cell therapies and gene therapies;
Amendment 339 #
Proposal for a directive
Article 26 – paragraph 3 – point b
Article 26 – paragraph 3 – point b
(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance present or used in the manufacture of a medicinal product, including cell therapies and gene therapies;
Amendment 346 #
Proposal for a directive
Article 26 a (new)
Article 26 a (new)
Article 26a Additional platform technology master files 1. Marketing authorisation applicants may, instead of submitting the relevant data on the quality, safety and efficacy of a medicinal product, required in accordance with Annex II, rely on an additional platform technology master file or an additional platform technology master file certificate granted by the Agency in accordance with this Article (‘additional platform technology master file certificate’). 2. Article 25(1) to (5), (7) and (8) shall also apply mutatis mutandis to additional platform technology master file certification. 3. The description of the platform technology master file shall represent the applicant's basis for relevant data on quality, safety and efficacy of the medicinal product as required in Annex II. To adequately describe the platform technology master file, appropriate information as laid down in scientific guidelines published by the Agency shall be provided. 4. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying: (a) the rules governing the content and format of the application for an additional platform technology master file certificate; (b) additional platform technology master files for which a certificate may be used in order to provide specific information on the platform technology on the basis of which a substance present or used in the manufacture of a medicinal product is manufactured; (c) the rules for the examination of applications for making publicly available of additional platform technology master file certificates; (d) the rules for introducing changes to the additional platform technology master file and the certificate; (e) the rules on access for competent authorities of the Member State to the additional platform technology master file and its assessment report; (f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on a additional platform technology master file certificate to the additional platform technology master file and to the assessment report. 5. The Agency shall develop and publish scientific guidelines on the requirements for an additional platform technology master file. 6. If requested by the Agency, the manufacturer of a substance present or used in the manufacturing of a medicinal product for which an application for an additional platform technology master file certificate has been submitted or the additional platform technology master file certificate holder shall undergo an inspection to verify the information contained in the application or the master file. If the holder of the additional platform technology master file refuses to undergo such an inspection, the Agency may suspend or terminate the application for the additional platform technology master file certificate.
Amendment 346 #
Proposal for a directive
Article 26 a (new)
Article 26 a (new)
Article 26a Additional platform technology master files 1. Marketing authorisation applicants may, instead of submitting the relevant data on the quality, safety and efficacy of a medicinal product, required in accordance with Annex II, rely on an additional platform technology master file or an additional platform technology master file certificate granted by the Agency in accordance with this Article (‘additional platform technology master file certificate’). 2. Article 25(1) to (5), (7) and (8) shall also apply mutatis mutandis to additional platform technology master file certification. 3. The description of the platform technology master file shall represent the applicant's basis for relevant data on quality, safety and efficacy of the medicinal product as required in Annex II. To adequately describe the platform technology master file, appropriate information as laid down in scientific guidelines published by the Agency shall be provided. 4. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying: (a) the rules governing the content and format of the application for an additional platform technology master file certificate; (b) additional platform technology master files for which a certificate may be used in order to provide specific information on the platform technology on the basis of which a substance present or used in the manufacture of a medicinal product is manufactured; (c) the rules for the examination of applications for making publicly available of additional platform technology master file certificates; (d) the rules for introducing changes to the additional platform technology master file and the certificate; (e) the rules on access for competent authorities of the Member State to the additional platform technology master file and its assessment report; (f) the rules on access for marketing authorisation applicants and marketing authorisation holders relying on a additional platform technology master file certificate to the additional platform technology master file and to the assessment report. 5. The Agency shall develop and publish scientific guidelines on the requirements for an additional platform technology master file. 6. If requested by the Agency, the manufacturer of a substance present or used in the manufacturing of a medicinal product for which an application for an additional platform technology master file certificate has been submitted or the additional platform technology master file certificate holder shall undergo an inspection to verify the information contained in the application or the master file. If the holder of the additional platform technology master file refuses to undergo such an inspection, the Agency may suspend or terminate the application for the additional platform technology master file certificate.
Amendment 376 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h
Article 44 – paragraph 1 – subparagraph 1 – point h
(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or, including public health, includingand in particular antimicrobial resistance need to be further investigated after the medicinal product has been marketed;
Amendment 376 #
Proposal for a directive
Article 44 – paragraph 1 – subparagraph 1 – point h
Article 44 – paragraph 1 – subparagraph 1 – point h
(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or, including public health, includingand in particular antimicrobial resistance need to be further investigated after the medicinal product has been marketed;
Amendment 378 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
Amendment 378 #
Proposal for a directive
Article 47 – paragraph 1 – point d
Article 47 – paragraph 1 – point d
Amendment 381 #
Proposal for a directive
Article 47 – paragraph 1 a (new)
Article 47 – paragraph 1 a (new)
1 a. The national marketing authorisation may furthermore be refused if, after verification of the particulars and documentations referred to in Article 6 and subject to the specific requirements laid down in Articles 9 to 14, the view is taken that 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 applicant and the competent authority deems that post- authorisation environmental risk assessment studies in accordance with Article 44(1), point (h), would be an insufficient measure to ensure environmental protection.
Amendment 381 #
Proposal for a directive
Article 47 – paragraph 1 a (new)
Article 47 – paragraph 1 a (new)
1 a. The national marketing authorisation may furthermore be refused if, after verification of the particulars and documentations referred to in Article 6 and subject to the specific requirements laid down in Articles 9 to 14, the view is taken that 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 applicant and the competent authority deems that post- authorisation environmental risk assessment studies in accordance with Article 44(1), point (h), would be an insufficient measure to ensure environmental protection.
Amendment 383 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial; orf systemic administration;
Amendment 383 #
Proposal for a directive
Article 51 – paragraph 1 – point e
Article 51 – paragraph 1 – point e
(e) is an antimicrobial; orf systemic administration;
Amendment 385 #
Proposal for a directive
Article 51 – paragraph 1 – point e a (new)
Article 51 – paragraph 1 – point e a (new)
(e a) is an antibiotic; or
Amendment 385 #
Proposal for a directive
Article 51 – paragraph 1 – point e a (new)
Article 51 – paragraph 1 – point e a (new)
(e a) is an antibiotic; or
Amendment 391 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Articles 166 and 167, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 391 #
Proposal for a directive
Article 56 – paragraph 3 – subparagraph 1
Article 56 – paragraph 3 – subparagraph 1
The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Articles 166 and 167, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.
Amendment 403 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the Union, 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 403 #
Proposal for a directive
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The marketing authorisation holder shall declare to the public any direct financial support received from any public authority or publicly funded body of the Union, 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 408 #
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 body of the Union that provided the financial support referred to in point (i);
Amendment 408 #
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 body of the Union that provided the financial support referred to in point (i);
Amendment 415 #
Proposal for a directive
Article 57 – paragraph 6 a (new)
Article 57 – paragraph 6 a (new)
6 a. The Agency shall provide a publicly accessible website to facilitate access to the electronic links communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicine and by Member State.
Amendment 415 #
Proposal for a directive
Article 57 – paragraph 6 a (new)
Article 57 – paragraph 6 a (new)
6 a. The Agency shall provide a publicly accessible website to facilitate access to the electronic links communicated to the Agency in accordance with paragraphs 2 and 3, sorted, where relevant, by medicine and by Member State.
Amendment 422 #
Proposal for a directive
Article 58 a (new)
Article 58 a (new)
Article58a Obligation to submit an application for pricing and reimbursement in all Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibilities an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b. 2. For the purposes of paragraph 1 of this Article, Member States shall make their request within two years of the granting of a marketing authorisation and notify this in the EU Access to Medicines Notification System provided for in Article 58b. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. Where a Member State has not complied with the time limits laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State. Without prejudice to the deadline and procedure set out in paragraph 1, Member States shall in the case of vaccines have included this product in their national immunisation programme, or shall have initiated the process for this, before making their request. 3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement in good faith and within the limits of its responsibility only in the Member States where the relevant patient population has been identified. 4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. A Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall be considered to be fulfilled in that Member State. 5. The Commission shall, after consultation with the Agency, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. The inclusion of a medicinal product in that list shall where relevant take into account circumstances related to regulatory and reimbursement procedures pertaining to particular products, or to the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder. 7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential disputes related to the process for submission of applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. In respect of national competences with regard to assessments on the added value of a medicinal product or subsequent decisions on pricing and reimbursement as well as on budgetary decisions and the allocation of financial resources in the area of protection and improvement of human health, the conciliation mechanism shall exclude opinions on these issues. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency. 8. The provisions of this Article shall not prevent a marketing authorisation holder from submitting an application for pricing and reimbursement and placing a medicinal product on the market of a Member State without a Member State having made a request in accordance with paragraph 1. 9. The Commission shall assess barriers to timely access to medicinal products in each Member State as well as on an aggregated Union level and publish a report with the results of its assessment. The report shall be drawn up for the first time by [OP: Please insert date of the end of the second year after the date of entry into force of this Directive] and every four years thereafter.
Amendment 422 #
Proposal for a directive
Article 58 a (new)
Article 58 a (new)
Article58a Obligation to submit an application for pricing and reimbursement in all Member States 1. The marketing authorisation holder shall, upon request by a Member State in which the marketing authorisation is valid, submit in good faith and within the limits of its responsibilities an application for pricing and reimbursement for the medicinal product no later than two years from the date when the Member State made its request, or within four years from that date for any of the following entities: (i) SMEs; (ii) entities not engaged in an economic activity (‘not-for-profit entity’); and (iii) undertakings that, by the time of granting the marketing authorisation, have received not more than seven centralised marketing authorisations for the undertaking concerned or, in the case of an undertaking belonging to a group, for the group of which it is part, since the establishment of the undertaking or the group, whichever is earliest. For the purposes of this Directive and [revised Regulation (EC) No 726/2004], the Commission shall by ... [18 months after the date of entry into force of this Directive] adopt delegated acts in accordance with Article 215 to supplement this Directive by laying down the criteria to qualify as a micro, small and medium-sized enterprise, taking into account the specificities of enterprises of this sector within the Union. The marketing authorisation holder shall notify that it fulfilled the obligations set out in the first subparagraph through the EU Access to Medicines Notification System provided for in Article 58b. 2. For the purposes of paragraph 1 of this Article, Member States shall make their request within two years of the granting of a marketing authorisation and notify this in the EU Access to Medicines Notification System provided for in Article 58b. Following the filing for pricing and reimbursement by the marketing authorisation holder, Directive 89/105/EEC shall apply. Where a Member State has not complied with the time limits laid down in Directive 89/105/EEC, the obligation on the marketing authorisation holder set out in this Article shall be considered to be fulfilled in that Member State. Without prejudice to the deadline and procedure set out in paragraph 1, Member States shall in the case of vaccines have included this product in their national immunisation programme, or shall have initiated the process for this, before making their request. 3. By way of derogation from paragraph 1, the marketing authorisation holder for a designated orphan medicinal product or for an advanced therapy medicinal product may choose instead: (a) to make a medicinal product available to patients and the prescribing doctors who requested it; or (b) to submit an application for pricing and reimbursement in good faith and within the limits of its responsibility only in the Member States where the relevant patient population has been identified. 4. Following agreement between a Member State and a marketing authorisation holder, timelines that are different from those set out in paragraphs 1 and 2 may apply. A Member State may choose, after making a request in accordance with paragraph 1, to issue a product-specific waiver after which the obligation to submit an application shall be considered to be fulfilled in that Member State. 5. The Commission shall, after consultation with the Agency, adopt by means of implementing acts a list of products to be exempted from the obligations set out in this Article. The inclusion of a medicinal product in that list shall where relevant take into account circumstances related to regulatory and reimbursement procedures pertaining to particular products, or to the administration of a medicinal product in most Member States being impracticable. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 6. Where a marketing authorisation is transferred to a different legal entity before the end of the period referred to in paragraph 1, the obligations shall be transferred to the new marketing authorisation holder. 7. The Commission shall by means of implementing acts establish a conciliation mechanism to facilitate discussions between applicants and Member States to resolve potential disputes related to the process for submission of applications for pricing and reimbursement and with respect to the timelines set out in Directive 89/105/EEC. In respect of national competences with regard to assessments on the added value of a medicinal product or subsequent decisions on pricing and reimbursement as well as on budgetary decisions and the allocation of financial resources in the area of protection and improvement of human health, the conciliation mechanism shall exclude opinions on these issues. In the event of continued disagreement between an applicant and a Member State regarding the fulfilment of the obligations set out in this Article, the Commission shall be empowered to issue a legally binding Commission decision following an opinion of the Agency. 8. The provisions of this Article shall not prevent a marketing authorisation holder from submitting an application for pricing and reimbursement and placing a medicinal product on the market of a Member State without a Member State having made a request in accordance with paragraph 1. 9. The Commission shall assess barriers to timely access to medicinal products in each Member State as well as on an aggregated Union level and publish a report with the results of its assessment. The report shall be drawn up for the first time by [OP: Please insert date of the end of the second year after the date of entry into force of this Directive] and every four years thereafter.
Amendment 425 #
Proposal for a directive
Article 58 b (new)
Article 58 b (new)
Article 58b EU Access to Medicines Notification System 1. The Commission shall, in collaboration with the Member States, set up and maintain an electronic notification system (the “EU Access to Medicines Notification System”) as a single-entry point for the notification of compliance with the obligations set out in Article 58a. The EU Access to Medicines Notification System shall be interoperable with the other Union-wide data repositories for medicinal products. 2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a. 3. By ... [3 years following the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements, including on security aspects and data governance, which are necessary for the practical implementation of the EU Access to Medicines Notification System. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 4. By ... [5 years after the date of entry into force of this Directive] and every 3 years thereafter, the Commission shall present a report to the European Parliament and the Council on the use and functioning of the EU Access to Medicines Notification System. 5. By ... [5 years after the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).
Amendment 425 #
Proposal for a directive
Article 58 b (new)
Article 58 b (new)
Article 58b EU Access to Medicines Notification System 1. The Commission shall, in collaboration with the Member States, set up and maintain an electronic notification system (the “EU Access to Medicines Notification System”) as a single-entry point for the notification of compliance with the obligations set out in Article 58a. The EU Access to Medicines Notification System shall be interoperable with the other Union-wide data repositories for medicinal products. 2. The marketing authorisation holder shall use the EU Access to Medicines Notification System to notify their compliance with the obligations set out in Article 58a. In the Member States where the marketing authorisation is valid, the national competent authority shall use the EU Access to Medicines Notification System to indicate that the marketing authorisation holder has fulfilled its obligations set out in Article 58a. 3. By ... [3 years following the date of entry into force of this Directive], the Commission shall adopt implementing acts to establish technical and organisational requirements, including on security aspects and data governance, which are necessary for the practical implementation of the EU Access to Medicines Notification System. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2). 4. By ... [5 years after the date of entry into force of this Directive] and every 3 years thereafter, the Commission shall present a report to the European Parliament and the Council on the use and functioning of the EU Access to Medicines Notification System. 5. By ... [5 years after the date of entry into force of this Directive], the Commission shall assess the feasibility of extending the EU Access to Medicines Notification System to other areas of the process for pricing of medicinal products as set out in Directive 89/105/EEC and, if appropriate, adopt implementing acts to establish this extended system. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).
Amendment 435 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available electronically, or both 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 includedshall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the 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 patients as well as written and designed in a clear and understandable way.
Amendment 435 #
Proposal for a directive
Article 63 – paragraph 3
Article 63 – paragraph 3
3. Member States may decide that the package leaflet shall be made available electronically, or both 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 includedshall be made available electronically and be included in paper format in the packaging of a medicinal product. If the package leaflet is only made available electronically, the 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 patients as well as written and designed in a clear and understandable way.
Amendment 438 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet. If the package leaflet is only to be made available electronically, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.
Amendment 438 #
Proposal for a directive
Article 63 – paragraph 3 a (new)
Article 63 – paragraph 3 a (new)
3 a. If a Member State has decided that the package leaflet is only to be made available electronically, patients shall be made aware of their right to a printed copy of the package leaflet. If the package leaflet is only to be made available electronically, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.
Amendment 444 #
Proposal for a directive
Article 63 – paragraph 4 a (new)
Article 63 – paragraph 4 a (new)
4 a. Where the medicinal product is not intended to be delivered directly to and administered by the patient, the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 of this Article by making only the electronic version of the package leaflet mandatory in this specific context. In such a case, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.
Amendment 444 #
Proposal for a directive
Article 63 – paragraph 4 a (new)
Article 63 – paragraph 4 a (new)
4 a. Where the medicinal product is not intended to be delivered directly to and administered by the patient, the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 3 of this Article by making only the electronic version of the package leaflet mandatory in this specific context. In such a case, a package leaflet in paper format may still be provided on a voluntary basis by the marketing authorisation holder in addition to the electronic package leaflet.
Amendment 447 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
Amendment 447 #
Proposal for a directive
Article 63 – paragraph 5
Article 63 – paragraph 5
Amendment 455 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. TBy ... [12 months after the date of entry into force of this Directive], 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.
Amendment 455 #
Proposal for a directive
Article 63 – paragraph 6
Article 63 – paragraph 6
6. TBy ... [12 months after the date of entry into force of this Directive], 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.
Amendment 466 #
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Wheren accessing 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 according to relevant Union legislation, and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including advertising and marketing activities.
Amendment 466 #
Proposal for a directive
Article 63 – paragraph 7
Article 63 – paragraph 7
7. Wheren accessing 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 according to relevant Union legislation, and shall not allow the identification, profiling or tracking of individuals, nor shall it be used for commercial purposes including advertising and marketing activities.
Amendment 470 #
Proposal for a directive
Article 63 – paragraph 7 a (new)
Article 63 – paragraph 7 a (new)
7 a. The Agency shall develop a system providing public access to the electronic version of package leaflets. By ... [12 months after the date of entry into force of this Directive], the system shall be accessible in all Member States.
Amendment 470 #
Proposal for a directive
Article 63 – paragraph 7 a (new)
Article 63 – paragraph 7 a (new)
7 a. The Agency shall develop a system providing public access to the electronic version of package leaflets. By ... [12 months after the date of entry into force of this Directive], the system shall be accessible in all Member States.
Amendment 473 #
Proposal for a directive
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The package leaflet shall reflect the results ofFollowing a consultations with target patient groups to ensure that it is legible, clear and easy to useand other relevant stakeholders, the Commission shall adopt guidelines to ensure that the package leaflet is legible, clear and easy to use as well as on the need for and modalities of further user testing.
Amendment 473 #
Proposal for a directive
Article 64 – paragraph 3
Article 64 – paragraph 3
3. The package leaflet shall reflect the results ofFollowing a consultations with target patient groups to ensure that it is legible, clear and easy to useand other relevant stakeholders, the Commission shall adopt guidelines to ensure that the package leaflet is legible, clear and easy to use as well as on the need for and modalities of further user testing.
Amendment 479 #
Proposal for a directive
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
Amendment 479 #
Proposal for a directive
Article 67 – paragraph 1 – subparagraph 2
Article 67 – paragraph 1 – subparagraph 2
Medicinal products not subject to prescription shall not bear the safety features referred to in Annex IV, unless, by way of exception, they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b), or where the marketing authorisation holder chooses to do so voluntarily.
Amendment 479 #
Proposal for a directive
Article 67 – paragraph 1 – subparagraph 2
Article 67 – paragraph 1 – subparagraph 2
Medicinal products not subject to prescription shall not bear the safety features referred to in Annex IV, unless, by way of exception, they have been listed in accordance with the procedure referred to in paragraph 2, second subparagraph, point (b), or where the marketing authorisation holder chooses to do so voluntarily.
Amendment 484 #
Proposal for a directive
Article 67 – paragraph 7 a (new)
Article 67 – paragraph 7 a (new)
7 a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.
Amendment 484 #
Proposal for a directive
Article 67 – paragraph 7 a (new)
Article 67 – paragraph 7 a (new)
7 a. For the purpose of patient safety, Member States may decide that medicinal products imported or distributed in parallel shall be repackaged in new outer packaging.
Amendment 486 #
Proposal for a directive
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4 a) ‘plasma for fractionation’ means the liquid part of human blood separated from whole blood or collected by apheresis and intended to be used as the starting material for manufacture of plasma-derived medicinal products;
Amendment 486 #
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 paper format or both in paper format and 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 486 #
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 paper format or both in paper format and 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 493 #
Proposal for a directive
Article 74 – paragraph 4 a (new)
Article 74 – paragraph 4 a (new)
4 a. Where a competent authority grants a full or partial exemption to the language requirements in accordance with paragraph 4, patients' right to a copy of the document in the official language of the Member State shall be guaranteed upon request and free of charge.
Amendment 493 #
Proposal for a directive
Article 74 – paragraph 4 a (new)
Article 74 – paragraph 4 a (new)
4 a. Where a competent authority grants a full or partial exemption to the language requirements in accordance with paragraph 4, patients' right to a copy of the document in the official language of the Member State shall be guaranteed upon request and free of charge.
Amendment 503 #
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 a public health emergency, the data and market protection shall be suspended for the indication that is relevant to the public health emergency with regard to that party insofar as the compulsory licence requires, in the relevant Member States and during the duration period of the compulsory licence.
Amendment 503 #
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 a public health emergency, the data and market protection shall be suspended for the indication that is relevant to the public health emergency with regard to that party insofar as the compulsory licence requires, in the relevant Member States and during the duration period of the compulsory licence.
Amendment 504 #
Proposal for a directive
Article 80 – paragraph 4 a (new)
Article 80 – paragraph 4 a (new)
4 a. The marketing authorisation holder for the medicinal product for which a compulsory licence has been granted shall be informed of the decision without delay.
Amendment 504 #
Proposal for a directive
Article 80 – paragraph 4 a (new)
Article 80 – paragraph 4 a (new)
4 a. The marketing authorisation holder for the medicinal product for which a compulsory licence has been granted shall be informed of the decision without delay.
Amendment 506 #
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixnine 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 506 #
Proposal for a directive
Article 81 – paragraph 1
Article 81 – paragraph 1
1. The regulatory data protection period shall be sixnine 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 511 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
Article 81 – paragraph 2 – subparagraph 1 – point a
Amendment 511 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point a
Article 81 – paragraph 2 – subparagraph 1 – point a
Amendment 524 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b
Article 81 – paragraph 2 – subparagraph 1 – point b
(b) six12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;
Amendment 524 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point b
Article 81 – paragraph 2 – subparagraph 1 – point b
(b) six12 months, where the marketing authorisation applicant demonstrates at the time of the initial marketing authorisation application that the medicinal product addresses an unmet medical need as referred to in Article 83;
Amendment 530 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
Article 81 – paragraph 2 – subparagraph 1 – point c
(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;
Amendment 530 #
Proposal for a directive
Article 81 – paragraph 2 – subparagraph 1 – point c
Article 81 – paragraph 2 – subparagraph 1 – point c
(c) six months, for medicinal products containing a new active substance, where the clinical trials supporting the initial marketing authorisation application use a relevant and evidence-based comparator in accordance with scientific advice provided by the Agency;
Amendment 546 #
Proposal for a directive
Article 82
Article 82
Amendment 546 #
Proposal for a directive
Article 82
Article 82
Amendment 576 #
Proposal for a directive
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or severely debilitating disease and the following conditions are met:
Amendment 576 #
Proposal for a directive
Article 83 – paragraph 1 – introductory part
Article 83 – paragraph 1 – introductory part
1. A medicinal product shall be considered as addressing an unmet medical need if at least one of its therapeutic indications relates to a progressive, life threatening or severely debilitating disease and the following conditions are met:
Amendment 581 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality, high mortality or significant negative impact on quality of life;
Amendment 581 #
Proposal for a directive
Article 83 – paragraph 1 – point a
Article 83 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such disease, or, where despite medicinal products being authorised for such disease in the Union, the disease is associated with a remaining high morbidity or mortality, high mortality or significant negative impact on quality of life;
Amendment 585 #
Proposal for a directive
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) the use of the medicinal product results in: (i) a meaningful reduction in disease morbidity or, mortality for the relevant patient population, severity or long term side effects for the relevant patient population; or (ii) a meaningful positive impact on quality of life; or (iii) a meaningful delay of the onset of the disease or its complications.
Amendment 585 #
Proposal for a directive
Article 83 – paragraph 1 – point b
Article 83 – paragraph 1 – point b
(b) the use of the medicinal product results in: (i) a meaningful reduction in disease morbidity or, mortality for the relevant patient population, severity or long term side effects for the relevant patient population; or (ii) a meaningful positive impact on quality of life; or (iii) a meaningful delay of the onset of the disease or its complications.
Amendment 600 #
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], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.
Amendment 600 #
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], representatives of patients’ organisations in the relevant disease areas, healthcare professionals, representatives of pharmaceutical industry and other relevant stakeholders.
Amendment 627 #
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 necessary activities conducted to generate data for an application, for:
Amendment 627 #
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 necessary activities conducted to generate data for an application, for:
Amendment 631 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 631 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) a marketing authorisation of generic, biosimilar, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 642 #
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
Amendment 662 #
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), may cover the submission of the application for a marketing authorisation and the offer, manufacture, sale, supply, storage, import, use and purchase of patented medicinal products or processes, including by third party suppliers and service providers.
Amendment 673 #
Proposal for a directive
Article 86 – paragraph 1 – subparagraph 1
Article 86 – paragraph 1 – subparagraph 1
Where an application for marketing authorisation, includes the results of all studies conducted in compliance with an agreed paediatric investigation plan, the holder of the patent or supplementary protection certificate shall be entitled to a six-month extension of the period referred to in Article 13, paragraphs 1 and 2 of [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted]. Where the agreed paediatric investigation plan is conducted in relation to a disease that is different from the one for which the medicinal product is intended in the adult population, the holder of the patent or supplementary protection certificate shall be entitled to a 12-month extension of the period.
Amendment 681 #
Proposal for a directive
Article 94 – paragraph 1
Article 94 – paragraph 1
1. On the basis of relevant paediatric clinical studies received in accordance with Article 45(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council76 , the competent authorities of the Member States may, following a consultation of the marketing authorisation holder, vary the marketing authorisation of the medicinal product concerned accordingly and update the summary of product characteristics and package leaflet of the medicinal product concerned. The competent authorities shall exchange information regarding the studies submitted and, as appropriate, their implications for any marketing authorisations concerned. _________________ 76 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1).
Amendment 685 #
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 696 #
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) use an appropriate wastewater treatment system.
Amendment 706 #
Proposal for a directive
Article 163 – paragraph 1
Article 163 – paragraph 1
1. The competent authority of the Member State concerned shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to an authorisation to engage in activity as a wholesaler in medicinal products (“wholesale distribution authorisation”). The wholesale distribution authorisation shall indicate the premises, the categories of medicinal products and the wholesale distribution operations for which it is valid.
Amendment 710 #
Proposal for a directive
Article 166 – paragraph 1 – point l
Article 166 – paragraph 1 – point l
Amendment 711 #
Proposal for a directive
Article 166 – paragraph 1 – point m
Article 166 – paragraph 1 – point m
(m) cooperate with all relevant stakeholders, including marketing authorisation holders and competent authorities of the Member States on the security of supply.
Amendment 712 #
Proposal for a directive
Article 166 – paragraph 1 a (new)
Article 166 – paragraph 1 a (new)
1 a. Member States shall designate wholesale distribution authorisation holders who shall continuously guarantee the appropriate and continued supply of an adequate range of medicinal products to meet the requirements of a specific geographical area, and deliver the supplies requested over the whole of the area in question, within a reasonable timeframe, which shall be defined in national legislation.
Amendment 725 #
Proposal for a directive
Article 177 – paragraph 4
Article 177 – paragraph 4
4. The prohibition contained in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.
Amendment 726 #
Proposal for a directive
Article 185 – paragraph 1 – point b
Article 185 – paragraph 1 – point b
(b) any supply of samples shall be in response to a written or electronic request, signed and dated, from the persons qualified to prescribe or supply medicinal products;
Amendment 730 #
Proposal for a directive
Article 188 – paragraph 15 a (new)
Article 188 – paragraph 15 a (new)
15 a. The Agency shall draw up guidelines on the use of the Union database.
Amendment 732 #
Proposal for a directive
Article 195 – paragraph 2
Article 195 – paragraph 2
2. The competent authorities of the Member States or, in the case of centralised marketing authorisation, the Commission may suspend, revoke or vary a marketing authorisation if a serious risk to the environment or, including public health, has been identified and not sufficiently addressed by the marketing authorisation holder. The competent authorities of the Member States or, in the case of a centralised marketing authorisation, the Commission may revoke a marketing authorisation in such cases only if it deems that those risks clearly outweigh the loss of positive therapeutic effects of the medicinal product for the concerned patient population and the risks cannot be mitigated following a decision of suspension or modification.
Amendment 744 #
Proposal for a directive
Article 206 – paragraph 2 – point e a (new)
Article 206 – paragraph 2 – point e a (new)
(e a) non-compliance with the obligations laid down in Article 58a shall be subject to the imposition of effective, proportionate and dissuasive financial penalties.
Amendment 746 #
Proposal for a directive
Article 207 – title
Article 207 – title
Collection and management of unused or expired medicinal products
Amendment 749 #
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 752 #
Proposal for a directive
Article 207 – paragraph 1 a (new)
Article 207 – paragraph 1 a (new)
1a. 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 754 #
Proposal for a directive
Article 207 – paragraph 1 b (new)
Article 207 – paragraph 1 b (new)
The national plans shall be submitted to the Commission.
Amendment 755 #
Proposal for a directive
Article 207 – paragraph 1 c (new)
Article 207 – paragraph 1 c (new)
From ... [five years after the date of entry into force of this Directive], the Commission is empowered to adopt delegated acts in accordance with Article 215 to amend paragraph 1a of this Article by supplementing or modifying the measures provided for in that paragraph if it is necessary to minimise the environmental risks posed by incorrect disposal of unused or expired medicinal products.
Amendment 759 #
Proposal for a directive
Article 215 – paragraph 2 – subparagraph 1
Article 215 – paragraph 2 – subparagraph 1
The power to adopt delegated acts referred to in Articles 4(2), 24(5), 25(9), 26(3), 28, paragraphs 2 and 3, 27(36a(4), 27(3), 28(2) and (3), 58a(1), 63(54a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 shall be conferred on the Commission for a period of five years from [OP please insert the date of the entry into force of this Directive]. 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 760 #
Proposal for a directive
Article 215 – paragraph 3
Article 215 – paragraph 3
3. The delegation of power referred to in Articles 4(2), 24(5), 25(9), 26(3), 27(3), 28, paragraphs 2 and 36a(4), 27(3), 28(2) and (3), 58a(1), 63(54a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 761 #
Proposal for a directive
Article 215 – paragraph 6
Article 215 – paragraph 6
6. A delegated act adopted pursuant to Articles 6(2), 26(3), 24(5), 28, paragraphs 2 and 3, 27(36a(4), 27(3), 28(2) and (3), 58a(1), 63(54a), 65(2), 67(2), 88(1), 92(4), 126(1), 150(3), 153(4), 161, 207(1c), 210(4) and 213 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two 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 two months at the initiative of the European Parliament or of the Council.
Amendment 763 #
Proposal for a directive
Annex IV – paragraph 1 – point a
Annex IV – paragraph 1 – point a
(a) the name of the medicinal product, including in Braille, followed by its strength and pharmaceutical form, and, if appropriate, whether it is intended for babies, children or adults; where the medicinal product contains up to three active substances, the international non- proprietary name (INN) shall be included, unless it is already part of the name of the medicinal product, or, if one does not exist, the common name;
Amendment 764 #
Proposal for a directive
Annex VI – paragraph 1 – point 2 a (new)
Annex VI – paragraph 1 – point 2 a (new)
(2 a) a key information section reflecting the results of consultations with patients’ organisations to ensure that the leaflet is legible, clear and easy to use;