43 Amendments of Andreas GLÜCK related to 2023/0131(COD)
Amendment 71 #
Proposal for a regulation
Recital 71 a (new)
Recital 71 a (new)
(71 a) Phased reviews have been a success during the COVID-19 Pandemic and led to a rapid authorisation of the urgently needed vaccines. An application in times outside of public health emergencies is therefore appropriate and the precedure should be extended to orphan medicinal products and medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition. Moreover, the Commission shall evaluate the performance of the phased reviews with the aim to further expand the category of medicinal products for which this procedure may apply.
Amendment 134 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders and the information available in the European Medicines Verifications System (EMVS). The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 168 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For orphan medicinal products and medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 209 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
The granting of a marketing authorisation as well as the granting of a temporary emergency marketing authorisation shall not affect the civil or criminal liability of the manufacturer or of the marketing authorisation holder pursuant to the applicable national law in Member States.
Amendment 259 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point a
Article 40 – paragraph 4 – subparagraph 1 – point a
(a) demonstrate capacity and ensure to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;
Amendment 316 #
Proposal for a regulation
Recital 71 a (new)
Recital 71 a (new)
(71 a) Phased reviews have been a success during the COVID-19 pandemic and led to a rapid authorisation of the urgently needed vaccines. An application in times outside of public health emergencies is therefore appropriate and the procedure should be extended to orphan medicinal products and medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition. Moreover, the Commission should evaluate the performance of the phased reviews with the aim to further expand the category of medicinal products for which this procedure may apply.
Amendment 349 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineten years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 350 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
Amendment 374 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 429 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the stimmediately as soon as they become awarte of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of suchwhich may include substantial concerns about the possibility of a temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 436 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the markeUnion critical medicinal products list. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 439 #
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products through IT surveillance systems or data bases including the European Medicines Verifications System (EMVS).
Amendment 470 #
Proposal for a regulation
Article 124 – paragraph 2 a (new)
Article 124 – paragraph 2 a (new)
2 a. The Agency shall assess actual critical shortages of medicinal products and provide recommendations to healthcare professionals and patients
Amendment 472 #
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and inlcude reference to alternative treatment options or products and appropriate communication that counteracts the hoarding of medicines as a result of the publication.
Amendment 486 #
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders and the information available in the European Medicines Verifications System (EMVS). The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 488 #
Proposal for a regulation
Recital 138 a (new)
Recital 138 a (new)
(138 a)In addition to existing and planned policy, legislative and regulatory measures, the Union need a strategic and coordinated industrial approach to ensure the security of supply of the most critical medicines. The Critical Medicines Alliance and the future Critical Medicines Act could allow national authorities, industry, civil society representatives, the Commission and the EU agencies to develop together coordinated actions at Union level against the shortages of medicines, in compliance with the competition rules and the Union’s international commitments. The future Critical Medicines Act could support the European green, digital manufacturing of critical medicines, APIs and intermediate ingredients, diversify the EU pharmaceutical supply chains and secure the strategic autonomy of critical medicines.
Amendment 491 #
Proposal for a regulation
Recital 138 c (new)
Recital 138 c (new)
(138 c) To complement this Regulation and as a first step to a more structural, long term approach to reduce Union dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries, the Commission should propose by (OP: 24 months after the date of entry into force of this Regulation) a legislative initiative for an EU Critical Medicines Act for supporting the European green, digital manufacturing of key medicines, active pharmaceutical ingredients, and intermediate pharmaceutical ingredients for which the Union is dependent on one country or a limited number of manufacturers.
Amendment 501 #
Proposal for a regulation
Article 134 – paragraph 2
Article 134 – paragraph 2
2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt an implementing act to improve security of supply. The implementing act may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant centities.ral bodies that take on the requirements themselves and only forward them to other relevant entities if needed
Amendment 602 #
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
For orphan medicinal products and medicinal products that are likely to offer an exceptional therapeutic advancement in the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Union, the Agency may, following the advice of the Committee for Medicinal Products for Human Use regarding the maturity of the data related to the development, offer to the applicant a phased review of complete data packages for individual modules of particulars and documentation as referred to in paragraph 1.
Amendment 616 #
Proposal for a regulation
Article 6 – paragraph 7 – subparagraph 2
Article 6 – paragraph 7 – subparagraph 2
If the Committee for Medicinal Products for Human Use accepts the request, the time-limit laid down in Article 6(6), first subparagraph, shall be reduced to 1520 days.
Amendment 621 #
Proposal for a regulation
Article 6 a (new)
Article 6 a (new)
Article6a Parallel application for one or more new indications (1) During the scientific assessment of an initial marketing authorisation application of a medicinal product by the Agency, the applicant may submit to the Agency a separate parallel application for one or more new indications concerning the same medicinal product. (2) The parallel application shall be assessed by the Agency as a marketing authorisation application in accordance with this Regulation, subject to the following: (a) To the extent the Committee for Medicinal Products for Human Use can assess the parallel application within the timeframe applicable to the initial marketing authorisation application, leading to the same outcome for both applications it shall group the applications and issue a single opinion. (b) To the extent the said Committee cannot issue an opinion on the parallel application within the timeframe applicable to the initial marketing authorisation application the parallel application shall be converted to a Type II variation application in accordance with Commission Regulation (EC) No 1234/2008. (c) If the initial marketing authorisation application is withdrawn or receives a negative opinion from the Committee for Medicinal Products for Human Use, the Committee will pursue the assessment of the parallel application as a standalone marketing authorisation application.
Amendment 668 #
Proposal for a regulation
Article 15 – paragraph 1 – point d
Article 15 – paragraph 1 – point d
(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments;
Amendment 741 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
The granting of a marketing authorisation as well as the granting of a temporary emergency marketing authorisation shall not affect the civil or criminal liability of the manufacturer or of the marketing authorisation holder pursuant to the applicable national law in Member States.
Amendment 766 #
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 2
Article 26 – paragraph 4 – subparagraph 2
In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data.
Amendment 872 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point a
Article 40 – paragraph 4 – subparagraph 1 – point a
(a) demonstrate capacity and ensure to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;
Amendment 1125 #
Proposal for a regulation
Article 70
Article 70
Amendment 1171 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineten years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1174 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
Amendment 1222 #
Proposal for a regulation
Article 72 – paragraph 1
Article 72 – paragraph 1
Amendment 1231 #
Proposal for a regulation
Article 72 – paragraph 1 – subparagraph 1
Article 72 – paragraph 1 – subparagraph 1
Amendment 1474 #
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than six months before the stimmediately as soon as they become awarte of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of suchwhich may include substantial concerns about the possibility of a temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 1498 #
Proposal for a regulation
Article 117 – paragraph 1
Article 117 – paragraph 1
1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the markeUnion critical medicinal products list. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.
Amendment 1509 #
Proposal for a regulation
Article 118 – paragraph 1 – subparagraph 1
Article 118 – paragraph 1 – subparagraph 1
Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products through IT surveillance systems or data bases including the European Medicines Verifications System (EMVS).
Amendment 1533 #
Proposal for a regulation
Article 120 – paragraph 2
Article 120 – paragraph 2
2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1543 #
Proposal for a regulation
Article 121 – paragraph 1 – point b a (new)
Article 121 – paragraph 1 – point b a (new)
(b a) establish an accessible and easily understandable system for patients and patient organisations to report shortages of medicinal products;
Amendment 1552 #
Proposal for a regulation
Article 121 – paragraph 1 – point c a (new)
Article 121 – paragraph 1 – point c a (new)
(c a) address recommandations to health professionals and patients on the alternative medicinal products to use to pursue treatments;
Amendment 1597 #
Proposal for a regulation
Article 123 – paragraph 2 – subparagraph 1 (new)
Article 123 – paragraph 2 – subparagraph 1 (new)
After adopting the list of critical shortages of medicinal products, the MSSG may analyse the vulnerabilities in the supply chain of those medicines.
Amendment 1606 #
Proposal for a regulation
Article 123 – paragraph 4 – subparagraph 1 (new)
Article 123 – paragraph 4 – subparagraph 1 (new)
Member States, within the MSSG, may decide to activate the “Voluntary Solidarity Mechanism for medicines” to (a) notify a critical shortage of a medicinal product at national level to other Member States and the Commisison, (b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States, (c) organise, with the support of the Agency, meetings with the issuing Member States, the donating part and other relevant parties to discuss operational requirements, (d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicines.
Amendment 1613 #
Proposal for a regulation
Article 124 – paragraph 2 a (new)
Article 124 – paragraph 2 a (new)
2 a. The Agency shall assess actual critical shortages of medicinal products and provide recommendations to healthcare professionals and patients
Amendment 1617 #
Proposal for a regulation
Article 124 – paragraph 3
Article 124 – paragraph 3
3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and inlcude reference to alternative treatment options or products and appropriate communication that counteracts the hoarding of medicines as a result of the publication.
Amendment 1647 #
Proposal for a regulation
Article 129 – paragraph 1
Article 129 – paragraph 1
For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner. Commercially sensitive information shall only be available to the relevant authorities.
Amendment 1670 #
Proposal for a regulation
Article 130 – paragraph 6 a (new)
Article 130 – paragraph 6 a (new)
Amendment 1705 #
Proposal for a regulation
Article 134 – paragraph 1 a (new)
Article 134 – paragraph 1 a (new)
1 a. The Commission shall also work with the European Centre for Disease prevention and Control on building reliable forecasts of potentiel threats and potential shortages.