Sittings · Document

Draft report (COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)) 2023-11-21

Laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

Committee on the Environment, Public Health and Food Safety

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AM_Com_LegReport

Amendment 1707

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

2. Within two years of the entry into force of this Regulation, the Commission shall adopt an implementing act to improve security of supply. Based on the Union list of critical medicinal products established by Article 131, the implementing act shall set up, along the lines of the RescEU mechanism, a European stockpile of medicinal products of health and strategic importance (MISSs) that are at high risk of shortage or other relevant measures required to improve security of supply.

Or. fr

Amendment 1708

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against medicine shortages, in respect of the commitments taken in the framework of the “Voluntary Solidarity Mechanism for medicines”. The implementing act may impose minimum safety 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 entities. The implementing act may allow regulatory flexibilities to facilitate the authorisation and roll-out of alternatives, the upscalling of production or approval of alternative suppliers of raw materials or finished products and temporary extending shelf-life.

Or. en

Amendment 1709

Tomislav Sokol

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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, to be developed in consultation with marketing authorisation holders, patients’ organisations and other relevant stakeholders, may impose as a last resort solution, contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant justified and proportionate measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities, accounting for their respective responsibility in addressing the identified, underlying root causes of the supply security risk and patient impact.

Or. en

Amendment 1710

Fulvio Martusciello

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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, to be developed in consultation with marketing authorisation holders and other relevant stakeholders act, may impose, as a last resort solution, contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant justified and proportionate measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities, accounting for their respective responsibility in addressing the identified, underlying root causes of the supply security risk and patient impact.

Or. en

Amendment 1711

Margarita de la Pisa Carrión

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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, in consultancy with marketing authorisation holder, national agencys, and other relevant actors, may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant well balance measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities responding for their responsabilities facing root causes of suply risk .

Or. en

Amendment 1712

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt, after consultation with marketing authorisation holders and other stakeholders where relevant, 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 justified and proportionate measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

Or. en

Amendment 1713

Andreas Glück

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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 central bodies that take on the requirements themselves and only forward them to other relevant entities if needed.

Or. en

Justification

For example, expanding stock levels in hospital pharmacies and hospital supply pharmacies beyond the existing requirements is not suitable. Creating the additional space required involves considerable expenses. Multiple larger and decentralized reserve stocks can create significantly leaner, more efficient and more easily controllable processes that are also manageable in the event of a crisis. These bodies may also delegate tasks to smaller entities if deemed necessary.

Amendment 1714

Maria Angela Danzì

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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 other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

Or. it

Justification

If such emergency stocks are introduced, there is no need for the European Commission to impose contingency stock requirements in an implementing act

Amendment 1715

Andrey Slabakov

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

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 establish strategic reserves of active pharmaceutical ingredient or finished dosage forms, or impose other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

Or. en

Amendment 1716

Tilly Metz

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

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 entities.

2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt a delegated act to improve security of supply. The delegated 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 entities.

Or. en

Amendment 1717

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. In the event of critical shortages, the Commission may launch a joint procurement procedure in line with Article 12 of Regulation (EU) 2022/2371 on serious cross-border threats to health and repealing Decision No 1082/2013/EU1 d.

_________________

1 d 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.

Or. fr

Amendment 1718

Tilly Metz

Proposal for a regulation

Article 134 – paragraph 3

Text proposed by the Commission

Amendment

3. The implementing act referred to in paragraph 2 shall be adopted in accordance with the examination procedure referred to in Article 173(2).

3. The delegated act referred to in paragraph 2 shall be adopted in accordance with the procedure referred to in Article 175.

Or. en

Amendment 1719

Kateřina Konečná

Proposal for a regulation

Article 134 a (new)

Text proposed by the Commission

Amendment

Article 134a

Penalties for non-compliance with the prevention and mitigation of shortages

The competent authorities of the Member States and the Commission shall lay down dissuasive penalties for non-compliance by marketing authorisation holders with the specific obligations laid down in Chapter X. The European Commission shall lay down criteria for establishing the penalties, taking into account the highest penalties laid down amongst Member States before the application of this Regulation.

Or. en

Amendment 1720

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall provide the Member States and the institutions of the Union with the best possible scientific opinion on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human use, veterinary medicinal products, which is referred to it in accordance with the Union legal acts relating to medicinal products for human use or veterinary medicinal products.

The Agency shall provide the Member States and the institutions of the Union with the best possible scientific opinion on any question relating to the evaluation of the quality, safety, efficacy and environmental risk of medicinal products for human use, veterinary medicinal products, which is referred to it in accordance with the Union legal acts relating to medicinal products for human use or veterinary medicinal products.

Or. en

Amendment 1721

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – introductory part

Text proposed by the Commission

Amendment

The Agency, acting particularly through its Committees, shall carry out the following tasks:

The Agency, acting particularly through its Committees and working groups, shall carry out the following tasks:

Or. en

Amendment 1722

Margarita de la Pisa Carrión

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures;

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures; the Agency, may consult with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 and the health technology coordination group established by Article 3 of Regulation (EU) 2021/2282, to set out principles for the design of scientific studies;

Or. en

Amendment 1723

Fulvio Martusciello

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures;

Or. en

Amendment 1724

Andrey Slabakov

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures;

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures; the Agency, after consulting with relevant national authorities can support clinical trial sponsors with advice on methodological aspects relating to their trials and the use of affected clinical trial results for regulatory purposes;

Or. en

Amendment 1725

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) coordinating the scientific evaluation of the quality, safety and efficacy of medicinal products for human use, which are subject to Union marketing authorisation procedures;

(a) coordinating the scientific evaluation of the quality, safety, efficacy and environmental risk of medicinal products for human use, which are subject to Union marketing authorisation procedures;

Or. en

Amendment 1726

Tomislav Sokol

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the Agency, may consult with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 and the health technology coordination group established by Article 3 of Regulation (EU) 2021/2282, to set out principles for the design of scientific studies;

Or. en

Amendment 1727

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point b

Text proposed by the Commission

Amendment

(b) coordinating the scientific evaluation of the quality, safety and efficacy of veterinary medicinal products, which are subject to Union marketing authorisation procedures in accordance with Regulation (EU) 2019/6 and the performance of other tasks set out in Regulation (EU) 2019/6 and Regulation (EC) 470/2009;

(b) coordinating the scientific evaluation of the quality, safety, efficacy and environmental risk of veterinary medicinal products, which are subject to Union marketing authorisation procedures in accordance with Regulation (EU) 2019/6 and the performance of other tasks set out in Regulation (EU) 2019/6 and Regulation (EC) 470/2009;

Or. en

Amendment 1728

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point c

Text proposed by the Commission

Amendment

(c) transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets for the medicinal products for human use;

(c) transmitting on request and making publicly available assessment reports, summaries of product characteristics, periodic safety update reports, labels, package leaflets and AMR awareness cards, where applicable, for the medicinal products for human use;

Or. en

Amendment 1729

Kateřina Konečná

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point n

Text proposed by the Commission

Amendment

(n) creating a database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

(n) creating a database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets and for information on the medicinal products that have been placed on the market in each Member State; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

Or. en

Amendment 1730

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point n

Text proposed by the Commission

Amendment

(n) creating a database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leaflets and other important documents; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner;

Or. en

Amendment 1731

Sunčana Glavak, Tomislav Sokol

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point za a (new)

Text proposed by the Commission

Amendment

(za a) providing scientific and regulatory mechanisms to efficiently reduce the time lag from adult to pediatric marketing authorization of medicinal products that failed timely completion of PIP, such as guidelines for extrapolation, and for prospective real-world evidence cohorts (for example on pediatric patients receiving drugs “of label”), the aim of which is to obtain necessary evidence on the safety and efficacy of medicinal products already licensed for adult use;

Or. en

Amendment 1732

Sunčana Glavak, Tomislav Sokol

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point za b (new)

Text proposed by the Commission

Amendment

(za b) facilitating joint clinical studies and the efficient use of paediatric patients’ data to avoid duplication and to diminish the participation of children in numerous clinical trials by means such as stated in Article 95, paragraph 2 a (new)

Or. en

Amendment 1733

Fulvio Martusciello

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zb

Text proposed by the Commission

Amendment

(zb) coordinating assessment of and certifying quality master files for medicinal products for human use as well as, where necessary, coordinating inspections of manufacturers applying for or holding a certificate for a quality master file;

(zb) coordinating assessment of and certifying master files for medicinal products for human use as well as, where necessary, coordinating inspections of manufacturers applying for or holding a certificate for a master file;

Or. en

Amendment 1734

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zc

Text proposed by the Commission

Amendment

(zc) establishing a mechanism of consultation of authorities or bodies active along the life cycle of medicinal products for human use for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency, notably with the SoHO Coordination Board, Medical Devices Coordination Group, Coordination Group on the Health Technology Assessment and national pricing and reimbursement authorities;

Or. en

Amendment 1735

Tiemo Wölken

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point ze

Text proposed by the Commission

Amendment

(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, taking into account the specificities of the assessment of medicinal products;

(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, and where possible prioritizing replacement strategies such for example as non-animal in vitro and silico approaches, taking into account the specificities of the assessment of medicinal products;

Or. en

Amendment 1736

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point ze

Text proposed by the Commission

Amendment

(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, prioritising replacement strategies (e.g., non-animal in vitro and in silico approaches) of animal testing, taking into account the specificities of the assessment of medicinal products;

Or. en

Amendment 1737

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point ze

Text proposed by the Commission

Amendment

(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law and ensuring implementation of the One Health Approach, notably with the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, taking into account the specificities of the assessment of medicinal products;

Or. en

Amendment 1738

Stelios Kympouropoulos

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zi

Text proposed by the Commission

Amendment

(zi) providing regulatory support and scientific advice for, and facilitate the development, validation and regulatory uptake of new-approach methodologies that replace the use of animals in testing;

(zi) providing regulatory support and scientific advice for, and facilitate the development, validation and regulatory uptake of new-approach methodologies, and in silico methods, such as but not limited to computational modelling and simulation, that reduce, refine, or replace the use of animals in testing;

Or. en

Amendment 1739

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zi

Text proposed by the Commission

Amendment

(zi) providing regulatory support and scientific advice for, and facilitate the development, validation and regulatory uptake of new-approach methodologies that replace the use of animals in testing;

(zi) providing regulatory support and scientific advice for, and facilitate the development, validation, qualification and/or standardisation, and regulatory uptake of new-approach methodologies that replace the use of animals in testing;

Or. en

Amendment 1740

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 1 – subparagraph 2 – point zi

Text proposed by the Commission

Amendment

(zi) providing regulatory support and scientific advice for, and facilitate the development, validation and regulatory uptake of new-approach methodologies that replace the use of animals in testing;

(zi) providing regulatory support and scientific advice for, and facilitate the development, validation and regulatory uptake of new-approach methodologies (NAMs) that replace the use of animals in testing;

Or. en

Amendment 1741

Tilly Metz

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, the package leaflet and the information shown on the labelling. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to Article 40(4), point (b), and Article 57 of [revised Directive 2001/83/EC].

The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, product assessment reports, periodic safety update reports, where applicable documentation related to received scientific advice, environmental risk assessment reports, the package leaflet, the information shown on the labelling, awareness cards in case of antimicrobials, post-marketing obligations related to the medicinal product, dates of expiry of IP and regulatory data and market protection periods, shortage prevention and, where relevant, mitigation plans, and information in which Member States is the product placed on the market. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to Article 57 and 57a of [revised Directive 2001/83/EC].

Or. en

Amendment 1742

Kateřina Konečná

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, the package leaflet and the information shown on the labelling. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to Article 40(4), point (b), and Article 57 of [revised Directive 2001/83/EC].

The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, the package leaflet and the information shown on the labelling. For each medicinal product, it should be reported in which Member State(s) it is placed on the market. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to Article 57 of [revised Directive 2001/83/EC].

Or. en

Amendment 1743

Tiemo Wölken

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) marketing authorisation holder shall electronically submit to the agency information on which Member States the medical products for human use authorised in the Union have been placed.

Or. en

Amendment 1744

Kateřina Konečná

Proposal for a regulation

Article 138 – paragraph 2 – subparagraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) marketing authorisation holders shall report to the Agency in which Member State(s) the authorised medicinal products have been placed on the market.

Or. en

Amendment 1745

Tomislav Sokol

Proposal for a regulation

Article 139 – title

Text proposed by the Commission

Amendment

Coherence of scientific opinions with other Union bodies

Coherence of scientific opinions with other bodies

Or. en

Amendment 1746

Tomislav Sokol

Proposal for a regulation

Article 139 – paragraph 1

Text proposed by the Commission

Amendment

1. The Agency shall take the necessary and appropriate measures to monitor and identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other Union bodies and agencies carrying out similar tasks in relation to issues of common concern.

1. The Agency shall take the necessary and appropriate measures to monitor and identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies and agencies carrying out similar tasks in relation to issues of common concern.

Or. en

Amendment 1747

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 139 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a substantive divergence over scientific or technical issues is identified and the body concerned is a Union Agency or a scientific committee, the Agency and the body concerned shall cooperate to resolve the divergence, and inform the Commission without undue delay.

3. Where a substantive divergence over scientific or technical issues is identified, the Agency will use best efforts to cooperate with the body concerned to resolve the divergence, and inform the Commission without undue delay.

Or. en

Amendment 1748

Sunčana Glavak

Proposal for a regulation

Article 142 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) the Committee for Paediatric and Orphan Medicinal Products (CPOMP)

Or. en

Amendment 1749

Maria Angela Danzì

Proposal for a regulation

Article 142 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(fa) The paediatric working group should provide scientific support and expertise to all Agency bodies on all matters relating to the development and use of paediatric medicines;

Or. it

Justification

The extensive expertise acquired within the PDCO must not go to waste. Therefore, a paediatric working group could assist the Agency in addressing issues related to the development of paediatric medicines. A working group would be a less bureaucratic way of doing this, as a smaller body practising high scientific standards.

Amendment 1750

Tilly Metz

Proposal for a regulation

Article 142 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) the Environmental Risk Assessment working party;

Or. en

Amendment 1751

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 142 – paragraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) an ad hoc working group on Advanced Therapy Medicinal Products;

Or. en

Amendment 1752

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Article 142 – paragraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) an ad hoc working group on Advanced Therapy Medicinal Products;

Or. en

Amendment 1753

Tomislav Sokol

Proposal for a regulation

Article 142 – paragraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) an ad hoc working group on Advanced Therapy Medicinal Products;

Or. en

Amendment 1754

Susana Solís Pérez

Proposal for a regulation

Article 142 – paragraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) an ad hoc working group on Advanced Therapy Medicinal Products;

Or. en

Amendment 1755

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 142 – paragraph 1 – point j b (new)

Text proposed by the Commission

Amendment

(j b) an ad hoc working group on Orphan Medicinal Products

Or. en

Amendment 1756

Frédérique Ries, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 142 – paragraph 1 – point j b (new)

Text proposed by the Commission

Amendment

(j b) an ad hoc working group on Orphan Medicinal Products;

Or. en

Amendment 1757

Susana Solís Pérez

Proposal for a regulation

Article 142 – paragraph 1 – point j b (new)

Text proposed by the Commission

Amendment

(j b) an ad hoc working group on Orphan Medicinal Products;

Or. en

Amendment 1758

Tomislav Sokol

Proposal for a regulation

Article 142 – paragraph 1 – point j b (new)

Text proposed by the Commission

Amendment

(j b) an ad hoc working group on Orphan Medicinal Products;

Or. en

Amendment 1759

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 142 – paragraph 1 – point j c (new)

Text proposed by the Commission

Amendment

(j c) an ad hoc working group on Paediatric Products;

Or. en

Amendment 1760

Susana Solís Pérez, Ondřej Knotek

Proposal for a regulation

Article 142 – paragraph 1 – point j c (new)

Text proposed by the Commission

Amendment

(j c) an ad hoc working group on Paediatric Products;

Or. en

Amendment 1761

Tomislav Sokol

Proposal for a regulation

Article 142 – paragraph 1 – point j c (new)

Text proposed by the Commission

Amendment

(j c) an ad hoc working group on Paediatric Committee;

Or. en

Amendment 1762

Susana Solís Pérez, Ondřej Knotek

Proposal for a regulation

Article 142 – paragraph 1 – point k a (new)

Text proposed by the Commission

Amendment

(k a) a reservoir of specialists drawn from Member States and key interested parties to serve on ad hoc working groups; members will be chosen for their pertinent expertise corresponding to the varied ad hoc working groups' needs, enabling them to contribute to regulatory support and scientific advisory processes, while ensuring they are not subject to any conflicts of interest.

Or. en

Amendment 1763

Tomislav Sokol

Proposal for a regulation

Article 142 – paragraph 1 – point k a (new)

Text proposed by the Commission

Amendment

(k a) a pool of experts from Member States and relevant stakeholders to work in the ad hoc working groups; the members shall be selected based on relevant experience in relation to the different ad hoc working groups, so they can contribute to the regulatory support and scientific advice procedures, and they shall be free of any conflicts of interest.

Or. en

Amendment 1764

Sunčana Glavak

Proposal for a regulation

Article 142 – paragraph 1 – point k a (new)

Text proposed by the Commission

Amendment

(k a) a pool of pediatric experts from Member States and other relevant stakeholders, with relevant experience to work in ad hoc working groups

Or. en

Amendment 1765

Tilly Metz

Proposal for a regulation

Article 142 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) a Secretariat, which shall provide technical, scientific and administrative support to all bodies of the Agency and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group referred to in Article 37 of [revised Directive 2001/83/EC] and ensure appropriate coordination between it and the Committees. It shall also undertake the work required of the Agency under the procedures for the assessment and preparations of decisions for paediatric investigation plans, waivers, deferrals or orphan designations.

(l) a Secretariat, which shall provide technical, scientific and administrative support to all bodies of the Agency and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group referred to in Article 37 of [revised Directive 2001/83/EC] and ensure appropriate coordination between it and the Committees. It shall also ensure implementation of all transparency commitments and undertake the work required of the Agency under the procedures for the assessment and preparations of decisions for paediatric investigation plans, waivers, deferrals or orphan designations.

Or. en

Amendment 1766

István Ujhelyi

Proposal for a regulation

Article 142 – paragraph 1 – point l a (new)

Text proposed by the Commission

Amendment

(l a) the Standing Working Party for Advanced Therapy Medicinal Products set up pursuant to Article 150 (7).

Or. en

Amendment 1767

Dolors Montserrat

Proposal for a regulation

Article 143 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Management Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights.

1. The Management Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights. In addition, two representatives of patient organisations, one representative of doctors’ organisations and one representative of veterinarians’ organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible and within three months of notification, the European Parliament may submit its views to the Council, which shall appoint these representatives to the Management Board. The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union.

Or. es

Justification

La propuesta limita la presencia de profesionales sanitarios en el Consejo de Administración a los médicos y veterinarios, respectivos prescriptores de los medicamentos de uso humano y veterinario, pero no incorpora al profesional farmacéutico, profesional sanitario experto en el medicamento y, en la mayoría de los Estados miembros, único profesional habilitado para su dispensación al público (la Directiva de cualificaciones profesionales de la UE, se refiere a estos profesionales como “especialistas en el sector de los medicamentos” y exige para su formación un conocimiento adecuado de los medicamentos y de las sustancias empleadas en su fabricación)..Por ello, entendemos indispensable permitir que un representante de la organización de un profesional de la salud como es el farmacéutico, experto en el ámbito del medicamento, amplíe aún más el alcance de los aportes y la información que estos profesionales pueden aportar a las discusiones en la Junta Directiva de la EMA, siendo esencial que no solo se encuentre presente el punto de vista de los profesionales prescriptores, sino también de los dispensadores.

Amendment 1768

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 143 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

In addition, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

In addition, two representatives of patients' organisations, one representative of doctors' organisations, one representative of pharmacists' organisations for their expertise on medicinal products and its responsibility for their management, and one representative of veterinarians' organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

Or. en

Amendment 1769

Margarita de la Pisa Carrión

Proposal for a regulation

Article 143 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

In addition, two representatives of patients' organisations, one representative of doctors' organisations and one representative of veterinarians' organisations, and a representative of pharmaceutical organisations all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

Or. en

Amendment 1770

Tiemo Wölken

Proposal for a regulation

Article 143 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

In addition, two representatives of patients' organisations, one representative of doctors' organisations , one representative of pharmacists’ organisations and one representative of veterinarians' organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

Or. en

Amendment 1771

Tilly Metz

Proposal for a regulation

Article 143 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union.

The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise, absence of direct or indirect conflict of interest, and the broadest possible geographic spread within the European Union.

Or. en

Amendment 1772

Tilly Metz

Proposal for a regulation

Article 143 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a balanced representation between men and women on the Management Board.

All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a gender balanced representation on the Management Board.

Or. en

Amendment 1773

Tilly Metz

Proposal for a regulation

Article 143 – paragraph 4

Text proposed by the Commission

Amendment

4. The term of office for members and their alternates shall be four years. That term shall be extendable.

4. The term of office for members and their alternates shall be four years. That term shall be extendable once consecutively.

Or. en

Amendment 1774

Maria Angela Danzì

Proposal for a regulation

Article 144 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) appoint the Executive Director, and where relevant extend their term of office or remove them from office, in accordance with Article 145;

(d) extend the term of office of the Executive Director or remove them from office in accordance with Article 145;

Or. it

Amendment 1775

Maria Angela Danzì

Proposal for a regulation

Article 145 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Executive Director shall be appointed by the Management Board from a list of candidates proposed by the Commission following an open and transparent selection procedure.

The European Parliament and the Council should appoint the Executive Director by common accord; the Council shall act by simple majority.

The director shall be appointed from a list of candidates proposed by the Commission, following an open and transparent selection procedure.

The procedure shall begin with a general call for applications published in the Official Journal of the European Union, following which a selection board of independent experts appointed by the Commission shall draw up a shortlist of three candidates who have the necessary qualifications and practical experience and are able to submit every guarantee of independence and integrity to the European Parliament and the Council.

Or. it

Amendment 1776

Maria Angela Danzì

Proposal for a regulation

Article 145 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Before appointment, the candidate nominated by the Management Board shall be immediately invited to make a statement to the European Parliament and to answer any questions put by its Members.

Before appointment, the candidates selected by the Commission shall be invited to appear before the competent committee of the European Parliament and to answer questions put by its Members.

Or. it

Amendment 1777

Maria Angela Danzì

Proposal for a regulation

Article 145 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 3, may extend the term of office of the Executive Director once, for no more than five years.

The Management Board, acting on a proposal from the Commission that takes into account the assessment referred to in paragraph 3 and, after hearing the opinion of Parliament, may extend the term of office of the Executive Director once, for no more than five years.

Or. it

Amendment 1778

Maria Angela Danzì

Proposal for a regulation

Article 145 – paragraph 5

Text proposed by the Commission

Amendment

5. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission.

5. The Executive Director may be removed from office only upon a decision of the Management Board acting on a proposal from the Commission and after hearing the opinion of the European Parliament

Or. it

Amendment 1779

Maria Angela Danzì

Proposal for a regulation

Article 145 – paragraph 6

Text proposed by the Commission

Amendment

6. The Management Board shall reach decisions on appointment, extension of the term of office or removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.

6. The Management Board shall reach decisions on extension of the term of office and removal from office of the Executive Director on the basis of a two-thirds majority of its members with voting rights.

Or. it

Amendment 1780

Maria Angela Danzì

Proposal for a regulation

Article 145 – paragraph 10 – point k a (new)

Text proposed by the Commission

Amendment

(ka) preparing draft internal rules for the prevention and management of conflict of interest in respect of the members of the Management Board and committees and presenting them to the Management Board for adoption;

Or. it

Amendment 1781

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 146 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Representatives from patients' organizations serving as members or alternate members on scientific committees shall receive remuneration from the Agency's budget, following the financial regulations that apply to the Agency.

Or. en

Amendment 1782

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher

Proposal for a regulation

Article 146 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Patient organisations representatives appointed as members and/or alternate members on scientific committees shall be compensated through the Agency’s budget, in accordance with the financial rules applicable to the Agency.

Or. en

Amendment 1783

Kateřina Konečná

Proposal for a regulation

Article 146 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Patients’ organisations representatives appointed as members and/or alternate members on scientific committees shall be remunerated through the Agency’s budget, in accordance with the financial rules applicable to the Agency.

Or. en

Amendment 1784

Maria Angela Danzì

Proposal for a regulation

Article 146 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

The scientific committees and any working parties and scientific advisory groups established in accordance with this Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use, in particular patient and consumer organisations and healthcare professionals’ associations. For that purpose working groups of patient and consumer organisations and healthcare professionals’ associations shall be established by the Agency. They shall ensure a fair representation of healthcare professionals, patients and consumers covering a wide range of experience and disease areas, including orphan, paediatric and geriatric diseases and advanced therapy medicinal products, and a broad geographical range.

The scientific committees and any working parties and scientific advisory groups established in accordance with this Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use, in particular patient and consumer organisations and healthcare professionals’ associations. For that purpose working groups of organisations of patients – including paediatric patients and representatives of young people – and healthcare professionals' associations shall be established by the Agency. They shall ensure a fair representation of healthcare professionals, patients and consumers covering a wide range of experience and disease areas, including orphan, paediatric and geriatric diseases and advanced therapy medicinal products, and a broad geographical range.

Or. it

Justification

According to the Agency's most recent communications, (the EMA's Principles on the involvement of young patients/consumers within EMA activities EMA/494077/2016), paediatric patients and youth representatives should be consulted and involved in its activities and their input should be sought.

Amendment 1785

Margarita de la Pisa Carrión

Proposal for a regulation

Article 146 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

The scientific committees and any working parties and scientific advisory groups established in accordance with this Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use, in particular patient and consumer organisations and healthcare professionals’ associations. For that purpose working groups of patient and consumer organisations and healthcare professionals’ associations shall be established by the Agency. They shall ensure a fair representation of healthcare professionals, patients (including diseases and pediatrics) and consumers covering a wide range of experience and disease areas, including orphan, paediatric and geriatric diseases and advanced therapy medicinal products, and a broad geographical range.

Or. en

Amendment 1786

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 146 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

The scientific committees and any working parties and scientific advisory groups established in accordance with this Article shall in general matters establish contacts, on an advisory basis, with parties concerned with the use of medicinal products for human use, in particular patient and consumer organisations, including paediatric patients, and healthcare professionals’ associations. For that purpose working groups of patient and consumer organisations and healthcare professionals’ associations shall be established by the Agency. They shall ensure a fair representation of healthcare professionals, patients and consumers covering a wide range of experience and disease areas, including orphan, paediatric and geriatric diseases and advanced therapy medicinal products, and a broad geographical range.

Or. en

Amendment 1787

Peter Liese

Proposal for a regulation

Article 146 – paragraph 8 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall report on the financial sources of patient organisations and their respective independence to ensure that patient organisations are as independent as possible from individual pharmaceutical companies. The Commission shall, if appropriate, propose measures to increase the independent financing of these organisations.

Or. en

Justification

"Patient organisations may often not be independent from pharmaceutical enterprises, weakening their ability to represent patient interests.

Amendment 1788

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 146 – paragraph 8 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

The Agency shall establish a procedure ensuring the remuneration through the Agency's budget, in accordance with the financial rules applicable to the Agency, of patients’ organisations representatives appointed as members or alternate members on scientific committees.

Or. en

Amendment 1789

Tomislav Sokol

Proposal for a regulation

Article 146 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. Patients’ organisations representatives appointed as members and/or alternate members on scientific committees shall be remunerated through the Agency’s budget, in accordance with the financial rules applicable to the Agency.

Or. en

Amendment 1790

Tilly Metz

Proposal for a regulation

Article 147 – title

Text proposed by the Commission

Amendment

Conflict of interest

Transparency and conflict of interest

Or. en

Amendment 1791

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 147 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.

Members of the Management Board, members of the committees, rapporteurs and experts shall not have financial or other interests in the pharmaceutical industry which could affect their impartiality and their independence. They shall undertake to act in the public interest and in an independent and transparent manner, and shall make an annual declaration of their financial interests and update them annually and whenever necessary. All indirect interests which could relate to this industry shall be entered in a register held by the Agency which is accessible to the public, on request, at the Agency's offices.

Or. en

Amendment 1792

Tilly Metz

Proposal for a regulation

Article 147 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Members of the Management Board, members of the committees, working parties and advisory committees, rapporteurs and experts, Executive Director, Deputy Executive Director and staff shall not have any direct or indirect financial or other interests in the pharmaceutical industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests which shall be made publicly available on the Agency’s website.

Or. en

Amendment 1793

Tilly Metz

Proposal for a regulation

Article 147 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts.

The Agency's code of conduct shall provide for the implementation of this Article.

Or. en

Amendment 1794

Maria Angela Danzì

Proposal for a regulation

Article 147 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts.

The Agency's code of conduct shall provide for the implementation of this Article with particular reference to the acceptance of gifts and similar perquisites.

Or. it

Amendment 1795

Maria Angela Danzì

Proposal for a regulation

Article 147 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Executive Director, the Deputy Executive Director, the members of the Management Board and the members of the Committees may not, for two years following the end of their term of office, hold any office or accept any assignment, or engage in any activity, whether remunerated or not, either on their own behalf or on behalf of any person over whom they have exercised regulatory, negotiating or authorising power, in a manner liable to influence the formulation or implementation of pharmaceutical policy or legislation or the decision-making processes of the Agency and the other European institutions.

Or. it

Amendment 1796

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 147 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where the Commission decides that a representative’s declared interest constitutes a conflict of interest, that representative shall not take part in any discussions or decisions, nor shall that representative obtain any information concerning that item of the agenda. Such declarations of representatives and the decision of the Commission shall be recorded in the summary minutes of the meeting.

Or. en

Amendment 1797

Tilly Metz

Proposal for a regulation

Article 147 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Agency shall make available the rules of procedure, agendas, minutes and members of the Management Board, committees, working parties and advisory committees on its website.

Or. en

Amendment 1798

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 147 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. The multidisciplinarity of experts may constitute a guarantee of the independence and impartiality of their work, and should be ensured to the best extent.

Or. en

Amendment 1799

Maria Angela Danzì

Proposal for a regulation

Article 148 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) four members and one alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

(b) four full members and one alternate member appointed by the Commission, so as to represent health professionals and patients, on the basis of a public call for expressions of interest and selected under a merit-based, transparent selection procedure implemented by independent experts, after consulting the European Parliament, in order to represent healthcare professionals;

Or. it

Amendment 1800

Maria Angela Danzì

Proposal for a regulation

Article 148 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) four members and four alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.

(c) four members and four alternate members appointed by the Commission, so as to represent patients' organisations, on the basis of a public call for expressions of interest, and selected under a merit-based, transparent selection procedure implemented by independent experts, after consulting the European Parliament, in order to represent patient organisations.

Or. it

Amendment 1801

Stanislav Polčák

Proposal for a regulation

Article 149 – paragraph 1

Text proposed by the Commission

Amendment

1. The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.

1. The mandate of the Pharmacovigilance Risk Assessment Committee shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions and the risk of negative environmental impacts, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.

Or. cs

Amendment 1802

Maria Angela Danzì

Proposal for a regulation

Article 149 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) six members appointed by the Commission, with a view to ensuring that the relevant expertise is available within the Committee, including clinical pharmacology and pharmacoepidemiology, on the basis of a public call for expressions of interest;

Or. it

Amendment 1803

Maria Angela Danzì

Proposal for a regulation

Article 149 – paragraph 2 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) two members and two alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

(c) two full members and two alternate members appointed by the Commission, so as to represent health professionals, on the basis of a public call for expressions of interest and selected under a merit-based, transparent selection procedure implemented by independent experts, after consulting the European Parliament, in order to represent healthcare professionals;

Or. it

Amendment 1804

Maria Angela Danzì

Proposal for a regulation

Article 149 – paragraph 2 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) two members and two alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.

(d) two members and two alternate members appointed by the Commission, so as to represent patients' organisations, on the basis of a public call for expressions of interest and selected under a merit-based, transparent selection procedure implemented by independent experts, after consulting the European Parliament, in order to represent patient organisations.

Or. it

Amendment 1805

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations, rare diseases and paediatric medicines, with the mandatory involvement of patients representatives and patient experts and their caregivers.

Or. en

Amendment 1806

Tomislav Sokol

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations, rare diseases and paediatric medicines with mandatory involvement of patients representatives and patient experts.

Or. en

Amendment 1807

Kateřina Konečná

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical, clinical evaluations, rare diseases and paediatric medicines with mandatory involvement of patients representatives and patient experts.

Or. en

Amendment 1808

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical, clinical evaluations, rare diseases and pediatric medicines, mandating the participation of patient representatives and patient experts.

Or. en

Amendment 1809

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations, rare diseases and pediatric medicines with the involvement of health professionals and patients representatives.

Or. en

Amendment 1810

Andrey Slabakov

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical, clinical evaluations, rare diseases and paediatric medicines with mandatory involvement of patients representatives and patient experts.

Or. en

Amendment 1811

Maria Angela Danzì

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations of rare diseases and paediatric medicines, with the involvement of experts and patients' representatives.

Or. it

Amendment 1812

Stelios Kympouropoulos

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical, clinical evaluations, orphan and paediatric medicines with patients representatives' and experts' mandatory involvement.

Or. en

Amendment 1813

Margarita de la Pisa Carrión

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations. taking into account patient representatives, especially on rare or pediatric diseases

Or. en

Amendment 1814

Tilly Metz

Proposal for a regulation

Article 150 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The Committee may establish an Environmental Risk Assessment working party and other scientific working parties, as necessary.

The Committee shall establish an Environmental Risk Assessment working party and other scientific working parties, as necessary.

Or. en

Amendment 1815

Andrey Slabakov

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) a high level of scientific expertise;

(a) a high level of scientific expertise, or being representative of patients and healthcare professionals;

Or. en

Amendment 1816

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) a high level of scientific expertise;

(a) a high level of scientific expertise or being representative of patients and healthcare professionals;

Or. en

Amendment 1817

Kateřina Konečná

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) a high level of scientific expertise;

(a) a high level of scientific expertise or being representative of patients and healthcare professionals;

Or. en

Amendment 1818

Tomislav Sokol

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) a high level of scientific expertise;

(a) a high level of scientific expertise or being representative of patients and healthcare professionals;

Or. en

Amendment 1819

Maria Angela Danzì

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(ba) the absence of conflicts of interest;

Or. it

Amendment 1820

Tilly Metz

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) absence of conflict of interest.

Or. en

Amendment 1821

Ondřej Knotek, Catherine Amalric, Billy Kelleher

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.

The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. Representatives of patients, caregivers, clinicians and academia shall be included as members of the working parties. Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.

Or. en

Amendment 1822

Stelios Kympouropoulos

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. Patients, caregivers, healthcare professionals, academia shall also be included as members of the working parties. Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.

Or. en

Amendment 1823

Kateřina Konečná

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States and patient representatives. Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.

Or. en

Amendment 1824

Tomislav Sokol

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1825

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 150 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1826

István Ujhelyi

Proposal for a regulation

Article 150 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. For advanced therapy medicinal products, the Committee for Human Medicinal Products shall establish a Standing Working Party for Advanced Therapy Medicinal Products. The members shall be selected based on their specific expertise that is relevant for advanced therapy medicinal products, including gene therapy, cell therapy, tissue engineering, medical devices, biotechnology, risk management and ethics. The working party will have the following tasks:

(a) to formulate a draft opinion on specific aspects of the quality, safety and efficacy of an advanced therapy medicinal product that is under review by the Committee for Medicinal Products for Human Use and to advise the latter on any data generated in the development of such a product;

(b) to provide advice, in the context of Article 61(1), on whether a product falls within the definition of an advanced therapy medicinal product;

(c) at the request of the Committee for Medicinal Products for Human Use, to advise on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in one of the scientific areas for which the working party has specific expertise;

(d) to provide advice on any question related to advanced therapy medicinal products, at the request of the Executive Director of the Agency or the Commission;

(e) to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of Regulation (EC) No 1394/2007;

(f) at the Commission’s request, to provide scientific expertise and advice for any Union initiative related to the development of innovative medicines and therapies which requires expertise in one of the scientific areas for which the working party has specific expertise;

(g) to contribute to the regulatory support and scientific advice procedures referred to in Article 138 (1) (p) and (za) of this Regulation and in Article 16 of Regulation (EC) No 1394/2007.

The working party will adopt its own rules of procedure and work in close collaboration with the Committee for Human Medicinal Products and representatives can attend all meetings of the committee where issues related to advanced therapy medicinal products are discussed.

Or. en

Amendment 1827

Maria Angela Danzì

Proposal for a regulation

Article 151 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall transmit to the Agency the names of national experts with proven experience in the evaluation of medicinal products for human use and veterinary medicinal products who, taking into account conflicts of interest pursuant to Article 147, would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 142, together with an indication of their qualifications and specific areas of expertise.

2. Member States shall transmit to the Agency the names of national experts, selected by an independent committee, with proven experience in the evaluation of medicinal products for human use and veterinary medicinal products who, after verifying the absence of conflicts of interest pursuant to Article 147, would be available to serve on working parties or scientific advisory groups of any of the committees referred to in Article 142, together with an indication of their qualifications and specific areas of expertise.

Or. it

Amendment 1828

Maria Angela Danzì

Proposal for a regulation

Article 151 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Where necessary, for the nomination of other experts the Agency may publish a call for expression of interest after endorsement by the Management Board of the necessary criteria and fields of expertise, in particular to ensure a high level of public health and animal protection.

Where necessary, for the nomination of other experts the Agency shall publish a call for expression of interest after endorsement by the Management Board of the necessary criteria and fields of expertise, in particular to ensure a high level of public health and animal protection. The selection procedure shall be carried out under rigorous criteria of transparency and independence.

Or. it

Amendment 1829

Kateřina Konečná

Proposal for a regulation

Article 152 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Where, in accordance with this Regulation, any of the Committees referred to in Article 142 is required to evaluate a medicinal product for human use, it shall appoint one of its members to act as rapporteur, taking into account existing expertise in the Member State. The Committee concerned may appoint a second member to act as co-rapporteur.

Or. en

Amendment 1830

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 152 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1831

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 152 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1832

Andrey Slabakov

Proposal for a regulation

Article 152 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1833

Stelios Kympouropoulos

Proposal for a regulation

Article 152 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1834

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 152 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1835

Tilly Metz

Proposal for a regulation

Article 152 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The person concerned, or their employer, shall be remunerated in accordance with [a scale of fees to be included in the financial arrangements established by the Management Board/mechanism under the new fee legislation].

The person concerned, or their employer, shall be remunerated in accordance with [a scale of fees to be included in the financial arrangements established by the EMA fees Regulation]

Or. en

Amendment 1836

Tomislav Sokol

Proposal for a regulation

Article 153 – paragraph 1

Text proposed by the Commission

Amendment

At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. The Agency shall, in collaboration with patients’ organisations and healthcare professionals, draw up guidelines for the determination of added therapeutic value.

Or. en

Amendment 1837

Tiemo Wölken

Proposal for a regulation

Article 153 – paragraph 1

Text proposed by the Commission

Amendment

At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. Guidelines for the determination of added therapeutic value shall be drawn up in collaboration with patient organisations and healthcare professionals.

Or. en

Amendment 1838

Kateřina Konečná

Proposal for a regulation

Article 153 – paragraph 1

Text proposed by the Commission

Amendment

At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. The Agency shall, in collaboration with patients’ organisations, draw up guidelines for the determination of added therapeutic value.

Or. en

Amendment 1839

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 153 – paragraph 1

Text proposed by the Commission

Amendment

At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. The Agency shall, in collaboration with patient organisations, draw up guidelines for the determination of added therapeutic value.

Or. en

Amendment 1840

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 153 – paragraph 1

Text proposed by the Commission

Amendment

At the request of the Commission, the Agency shall, in respect of authorised medicinal products for human use, collect any available information on methods that Member States' competent authorities use to determine the added therapeutic value that any new medicinal product for human use provides. The Agency shall jointly develop guidelines for assessing added therapeutic value with patient organizations.

Or. en

Amendment 1841

Tilly Metz

Proposal for a regulation

Article 154 – paragraph 4

Text proposed by the Commission

Amendment

4. Activities relating to the assessment of marketing authorisation applications, subsequent variations, pharmacovigilance, to the operation of communications networks and to market surveillance shall be under the permanent control of the Management Board in order to guarantee the independence of the Agency. This shall not preclude the Agency from charging fees to marketing authorisation holders for performing these activities by the Agency on the condition that its independence is strictly guaranteed.

Or. en

Amendment 1842

Tilly Metz

Proposal for a regulation

Article 158 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

The Agency shall provide detailed information in its annual report on the number of requests processed, pending and denied as well as an average time spent in the queuing system and its evolution over time.

The Agency shall allocate sufficient financial and human resources to respond to the access to documents requests within timelines outlined in Regulation (EC) No 1049/2001.

Or. en

Amendment 1843

István Ujhelyi

Proposal for a regulation

Article 162 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The consultation process shall include bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement.

The consultation process shall include bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement, while preserving the separation of their respective remits from the remit of the Agency.

Or. en

Amendment 1844

Tomislav Sokol

Proposal for a regulation

Article 162 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The consultation process shall include bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement.

The consultation process shall include bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 and national bodies responsible for pricing and reimbursement, taking into consideration their respective competences.

Or. en

Amendment 1845

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other relevant stakeholders. It may do so through the creation of a Regulatory Stakeholder Network that streamlines the consultation process.

Or. en

Amendment 1846

Tomislav Sokol

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other relevant stakeholders, as relevant. The Agency may establish a Regulatory Stakeholder Network to facilitate the consultation process.

Or. en

Amendment 1847

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other relevant stakeholders. The Agency may establish a Regulatory Stakeholder Network to facilitate the consultation process.

Or. en

Amendment 1848

Ondřej Knotek, Catherine Amalric, Billy Kelleher

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients and their caregivers, medicine developers, healthcare professionals, academia, industries or other stakeholders, as relevant.

Or. en

Amendment 1849

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, international organisations, industries or other stakeholders, as relevant.

Or. en

Amendment 1850

Frédérique Ries, Susana Solís Pérez, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, consumers, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

Or. en

Amendment 1851

Kateřina Konečná

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, consumers, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

Or. en

Amendment 1852

Tilly Metz

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall, where relevant, extend the consultation process to patients, consumers, medicine developers, healthcare professionals, industries or other stakeholders.

Or. en

Amendment 1853

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

Or. en

Amendment 1854

Jessica Polfjärd

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other relevant stakeholders.

Or. en

Justification

It is important that stakeholders subject for this regulation participate in identifying unmet medical needs from various and different perspectives. This is to ensure an established understanding of unmet medical needs relevant for this regulation. Representatives from diverse patient groups should be involved in these collaborations as well as industry and stakeholder engaged within health care in general.

Amendment 1855

István Ujhelyi

Proposal for a regulation

Article 162 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders, as relevant.

2. The Agency shall extend the consultation process to patients, medicine developers, healthcare professionals, industries or other stakeholders.

Or. en

Amendment 1856

Tilly Metz

Proposal for a regulation

Article 163 – paragraph 1

Text proposed by the Commission

Amendment

The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the healthcare professions. These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

The Management Board shall, in agreement with the Commission, develop appropriate contacts between the Agency and the representatives of the industry, consumers and patients and the healthcare professions, including through the Patients Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP). These contacts may include the participation of observers in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

Or. en

Amendment 1857

Cyrus Engerer

Proposal for a regulation

Article 164 – paragraph 1

Text proposed by the Commission

Amendment

1. The Agency shall ensure that micro, small and medium-sized enterprises (‘SMEs’) and not-for-profit entities are offered a support scheme.

1. The Agency shall ensure that micro, small and medium-sized enterprises (‘SMEs’), research institutes, academic institutions, and not-for-profit entities are offered a support scheme.

Or. en

Amendment 1858

Tilly Metz

Proposal for a regulation

Article 164 – paragraph 5

Text proposed by the Commission

Amendment

5. For not-for-profit entities, the Commission shall adopt specific provisions clarifying the definitions, establishing waivers, reductions or deferrals of fees, as appropriate, in accordance with the procedure referred to in Article 10 and Article 12 of [revised Regulation (EC) No 297/95].

Or. en

Amendment 1859

Tilly Metz

Proposal for a regulation

Article 165 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

Sufficient budget shall be allocated to the Agency to ensure appropriate implementation of its transparency obligations and commitments.

Or. en

Amendment 1860

Tiemo Wölken

Proposal for a regulation

Article 166 – paragraph 1

Text proposed by the Commission

Amendment

1. To support its public health tasks and in particular the evaluation and monitoring medicinal products or the preparation of regulatory decisions and scientific opinions, the Agency may process personal health data, from sources other than clinical trials, for the purpose of improving the robustness of its scientific assessment or verifying claims of the applicant or marketing authorisation holder in the context of the evaluation or supervision of medicinal product. The Agency must put in place sufficient, effective and specific technical and organisational measures to safeguard the fundamental rights and interests of data subjects in line with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725, including but not limited to clear and targeted data retention and deletion policies, state-of-the-art anonymisation and pseudonymisation requirements and techniques, confidentiality and data security measures, and access control mechanisms.

Or. en

Amendment 1861

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen, Andreas Glück

Proposal for a regulation

Article 166 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1862

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 166 – paragraph 1

Text proposed by the Commission

Amendment

1. To support its public health tasks and in particular the evaluation and monitoring of medicinal products or the preparation of regulatory decisions and scientific opinions, the Agency may process personal health data, from sources other than clinical trials, for the purpose of improving the robustness of its scientific assessment or verifying claims of the applicant or marketing authorisation holder in the context of the evaluation or supervision of medicinal product.

Or. en

Amendment 1863

Margarita de la Pisa Carrión

Proposal for a regulation

Article 166 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1864

Margarita de la Pisa Carrión

Proposal for a regulation

Article 166 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder. On that basis, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product.

deleted

Or. en

Amendment 1865

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 166 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder.

Upon evaluation of the totality of evidence, including the data submitted by the marketing authorisation applicant or marketing authorisation holder, if the Agency considers that a change to the summary of product characteristics may be appropriate due to the impact of such evidence on the benefit-risk balance of the medicinal product, the Agency shall share its proposal with the applicant or marketing authorisation holder without delay.

The applicant or marketing authorisation holder shall be provided with all the additional evidence including any relevant study documentation upon which the Agency proposal is based, and in compliance with applicable requirements set forth under Regulation (EU) 2016/679.

The applicant or marketing authorisation holder shall be invited to submit to the Agency their position on the evidence provided and, if necessary, shall be offered the opportunity of an explanation to discuss any proposed update to the summary of product characteristics as may be appropriate.

The Agency shall without undue delay inform the applicant or the marketing authorisation holder of its opinion.

Where the applicant or marketing authorisation holder disagrees with the Agency’s opinion, the applicant or marketing authorisation holder may request by written notice to the Agency a re-examination of the opinion. In that case, the applicant or marketing authorisation holder shall provide the Agency with the detailed grounds for the request within 30 days after receipt of the opinion.

Within 30 days following receipt of the grounds for the request, the Agency shall re-examine its opinion and shall issue a final opinion.

The reasons for the conclusion reached shall be annexed to the final opinion.

Where the final opinion of the Agency confirms the need for a change to the summary of product characteristics, the summary of product characteristics shall be updated.

Or. en

Amendment 1866

Tomislav Sokol

Proposal for a regulation

Article 166 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency may consider and decide upon additional evidence available, independently from the data submitted by the marketing authorisation applicant or marketing authorisation holder. On that basis, following consultation of the marketing authorisation holder or applicant, the summary of product characteristics shall be updated if the additional evidence has an impact on the benefit-risk balance of a medicinal product.

Or. en

Amendment 1867

Tomislav Sokol

Proposal for a regulation

Article 166 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. With relevance to paediatric medicinal products, the Agency may consider and decide upon additional evidence available from the real-world evidence cohorts, established following the guidelines of the Agency, independently from the data submitted by the marketing authorization applicant or marketing authorization holder.

Or. en

Amendment 1868

Sunčana Glavak

Proposal for a regulation

Article 166 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1869

Tilly Metz

Proposal for a regulation

Article 168 – paragraph 1

Text proposed by the Commission

Amendment

1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 and Directive (EU) 2019/1937 of the European Parliament and of the Council85 , and existing national provisions and practices in the Member States on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council86 , including intellectual property rights.

1. Unless otherwise provided for in this Regulation and without prejudice to Regulation (EC) No 1049/2001 and Directive (EU) 2019/1937 of the European Parliament and of the Council85 , and existing national provisions on confidentiality, all parties involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons in accordance with Directive (EU) 2016/943 of the European Parliament and of the Council86 , including intellectual property rights.

_________________

85 Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17).

86 Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).

Or. en

Justification

Since exiting national provisions, which should be compliant with EU law, shall condition confidentiality rules, any practices at national level have, by definition, to be compliant with national provisions. The reference to 'practices' is unnecessary and would risk validating problematic uncontrolled practices.

Amendment 1870

Tilly Metz

Proposal for a regulation

Article 168 – paragraph 4

Text proposed by the Commission

Amendment

4. Paragraphs 1, 2 and 3 do not affect the rights and obligations of the Commission, the Agency, Member States or other actors identified in this Regulation with regard to the exchange of information and the dissemination of warnings, nor do they affect the obligations of the persons concerned to provide information under criminal law.

Or. en

Amendment 1871

Tilly Metz

Proposal for a regulation

Article 170 – paragraph 3

Text proposed by the Commission

Amendment

3. On the occasion of every second evaluation, there shall be an assessment of the results achieved by the Agency having regard to its objectives, mandate, governance and tasks, including an assessment of whether the continuation of the Agency is still justified with regard to these objectives, mandate, governance and tasks. This assessment shall also include the experience acquired as a result of the operation of the procedures laid down in this Regulation and in Chapter III, Sections 4 and 5 of [revised Directive 2001/83/EC] on the basis of input from Member States and the Coordination group referred to in Article 37 of [revised Directive 2001/83/EC].

3. On the occasion of every evaluation, there shall be an assessment of the results achieved by the Agency having regard to its objectives, mandate, governance and tasks, including an assessment of whether the continuation of the Agency is still justified with regard to these objectives, mandate, governance and tasks. This assessment shall also include the experience acquired as a result of the operation of the procedures laid down in this Regulation and in Chapter III, Sections 4 and 5 of [revised Directive 2001/83/EC] on the basis of input from Member States and the Coordination group referred to in Article 37 of [revised Directive 2001/83/EC].

Or. en

Amendment 1872

Andrey Slabakov

Proposal for a regulation

Article 171 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate, differentiating between intentional and unintentional infringements, and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Or. en

Amendment 1873

Tilly Metz

Proposal for a regulation

Article 171 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When deciding on the amount of the penalty in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of persons affected and the level of damage suffered by them;

(b) whether penalties have been already applied by other competent authorities to the same infringing party;

(d) the intentional or negligent character of the infringement;

(e) any action taken by the infringing party to mitigate the damage of the infringement;

(f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement;

(g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement;

(i) the risk to public health presented by the falsification of medicinal products.

Or. en

Amendment 1874

Tilly Metz

Proposal for a regulation

Article 171 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. The non-compliance of an entity with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to competent authorities, shall be subject to penalties of up to 20 000 000 EUR, or in the case of an undertaking, up to 5% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case of ongoing non-compliance, the competent authority may fine the entity with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the competent authority pursuant to criteria laid down in paragraph 1a.

Or. en

Amendment 1875

Frédérique Ries, Susana Solís Pérez, Billy Kelleher

Proposal for a regulation

Article 172 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission may impose financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations.

1. The Commission shall impose financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations.

Or. en

Amendment 1876

Marian-Jean Marinescu

Proposal for a regulation

Article 172 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission may impose financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down under this Regulation and in Annex II in connection with the marketing authorisations.

Or. en

Justification

improving the strength of all the obligations laid down under this Regulation

Amendment 1877

Andrey Slabakov

Proposal for a regulation

Article 172 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission may impose appropriate and adequate financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down in Annex II in connection with the marketing authorisations.

Or. en

Amendment 1878

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission may impose financial penalties in the form of fines or periodic penalty payments on the marketing authorisations holder granted under this Regulation if they fail to comply with any of the obligations laid down in this Regulation and Annex II in connection with the marketing authorisations.

Or. en

Amendment 1879

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Commission shall impose financial penalties in the form of annual fines on the marketing authorisation holders, other than SMEs and entities not engaged in economic activity, for the absence of sufficient investment in antimicrobial R&D. These penalty payments shall be directly allocated to the European Antimicrobial Innovation Fund, established under Regulation (EU) 2021/522.

Or. en

Amendment 1880

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of persons affected and the level of damage suffered by them;

Or. en

Amendment 1881

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a b (new)

Text proposed by the Commission

Amendment

(a b) whether penalties have been already applied by other competent authorities to the same infringing party;

Or. en

Amendment 1882

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a c (new)

Text proposed by the Commission

Amendment

(a c) the size and market share of the entity committing the infringement;

Or. en

Amendment 1883

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a d (new)

Text proposed by the Commission

Amendment

(a d) the intentional or negligent character of the infringement;

Or. en

Amendment 1884

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a e (new)

Text proposed by the Commission

Amendment

(a e) any action taken by the infringing party to mitigate the damage of the infringement;

Or. en

Amendment 1885

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a f (new)

Text proposed by the Commission

Amendment

(a f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement;

Or. en

Amendment 1886

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a g (new)

Text proposed by the Commission

Amendment

(a g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

Or. en

Amendment 1887

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a h (new)

Text proposed by the Commission

Amendment

(a h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement;

Or. en

Amendment 1888

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 5 – point a i (new)

Text proposed by the Commission

Amendment

(a i) the risk to public health presented by the falsification of medicinal products.

Or. en

Amendment 1889

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 6 – subparagraph 1

Text proposed by the Commission

Amendment

Where the Commission finds that the marketing authorisation holder has failed, intentionally or negligently, to comply with its obligations, as referred to in paragraph 1, it may adopt a decision imposing a fine not exceeding 5 % of the marketing authorisation holder’s Union turnover in the business year preceding the date of that decision.

Where the Commission finds that the marketing authorisation holder has failed, intentionally or negligently, to comply with its obligations, as referred to in paragraph 1, it may adopt a decision imposing a fine not exceeding 20 000 000 EUR or 5 % of the marketing authorisation holder’s Union turnover in the business year preceding the date of that decision, whichever is higher.

Or. en

Amendment 1890

Tilly Metz

Proposal for a regulation

Article 172 – paragraph 10 – point a a (new)

Text proposed by the Commission

Amendment

(a a) levels of financial penalties in relation to paragraph 1a, including setting of eligibility criteria of what constitutes a sufficient investment in antimicrobial R&D;

Or. en

Amendment 1891

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 175 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt delegated acts referred to in Articles 3(5), 19(8), 21, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4) and 172(10) shall be conferred on the Commission for a period of five years from [date of entry into force]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

2. The power to adopt delegated acts referred to in Articles 3(5), 19(8), 21, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4), 133a and 172(10) shall be conferred on the Commission for a period of five years from [date of entry into force]. 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.

Or. fr

Amendment 1892

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 175 – paragraph 3

Text proposed by the Commission

Amendment

3. The delegation of power referred to in Articles 3(5), 19(8), 21, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4) and 172(10) 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.

3. The delegation of power referred to in Articles 3(5), 19(8), 21, 47(4), 49(2), 63(2), 67(4), 75(3), 81(4), 133a and 172(10) 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.

Or. fr

Amendment 1893

Tilly Metz

Proposal for a regulation

Article 176 a (new)

Regulation (EC) 851/2004

Article 11a, 11b, 11c, 17a, 19

Text proposed by the Commission

Amendment

Article176a

Amendments to Regulation (EC) No 851/2004

Regulation (EC) No 851/2004 is amended as follows:

(1) the following Article 11a is inserted:

"Article 11a

European Health Emergency Preparedness and Response Authority

1. The Health Emergency Preparedness and Response Authority (HERA) is hereby established as a separate structure under the legal personality of the European Centre for Disease Prevention and Control (ECDC), established under Regulation (EU) No 851/2004.

2. The Authority shall be responsible for creating, coordinating and implementing of the long-term European portfolio of biomedical research and development agenda for medical countermeasures against current and emerging public health threats as well as the, production, procurement, stockpiling and distribution capacity of medical countermeasures and other priority medical products in the EU.

3. The Authority is represented by the Executive Director of the European Centre for Disease Prevention and Control."

(2) the following Article 11b is inserted:

"Article 11b

Objectives and tasks of the Authority

1. The Authority shall provide the Member States and the institutions of the Union with strategic direction, resources to develop a robust biomedical R&D capacity to address major public health issues. The Authority shall carry out the following tasks: (a) setting out a long-term European portfolio or research and development projects in line with public health priorities set by the Commission in consultation with the World Health Organisation;

(b) setting and supporting biomedical R&D projects addressing at least the following areas: (i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account any equivalent list of priority pathogens adopted at Union level; (ii) the development of critical medicinal products pursuant to Article 6 of Regulation (EU) 123/2022;

(c) setting up and management of collaboration with third-party research centres at national and European level, non-for profit entities, academia and industry;

(d) providing strategic advice on the allocation of the EU Antimicrobial Innovation Fund;

(e) proving strategic advice to the Commission on the allocation of relevant EU grants for biomedical R&D, including under Horizon Europe, EU4Health Programme, Recovery and Resilience Facility and the Emergency Support Instrument;

(f) detecting biological and other health threats soon after they emerge, evaluating their impacts and identify potential counter measures;

(g) assessing and addressing vulnerabilities in global supply chains and strategic dependencies within the Union related to availability of critical medicines in coordination with the Medicine Shortages Steering Group and Medical Device Shortages Steering Group, established under Regulation (EU) 2022/123;

(h) identifying and ensuring the availability of production sites for priority products in the EU;.

(i) facilitating joint procurement and the roll-out of medical products in Member States;

(j) monitoring compliance with funding and procurement agreements;

(k) establishing a mechanism of consultation and cooperation, in line with the one health approach, internally within the European Centre of Disease Prevention and Control and with other EU bodies and agencies, in particular the European Medicines Agency, European Food Safety Authority and European Environment Agency.

2. The Commission is empowered to adopt delegated acts under Article 25 to set provisions related to paragraph 1 points (a) and (b);

3. The Commission is empowered to adopt delegated acts under Article 25 to expand the priority research agenda set in paragraph 1 point (b), in order to address other areas of unmet medical need."

(3) the following Article 11c is inserted:

"Article 11c

Development of priority antimicrobials

1. The Authority shall have at its disposal a comprehensive set of tools and incentives for the development of priority antimicrobials as referred to in Article 11a(b)(i). Financial resources shall be allocated from the EU AMR Fund, as established in Article 11d. Other tools may include:

(a) market entry rewards;

(b) advance purchase agreements;

(d) subscription payments.

2. Allocation of financial and other incentives shall be subject to the following principles and conditions:

(a) open science;

(b) affordability and EU-wide availability of developed products;

(d) full transparency of all received funding and purchase agreements;

(e) gradient incentive scheme that rewards according to the innovation level1a;

(f) development of a stewardship and access plan.

(4) in Article 13 the following point is added:

(ba) HERA Board;

(5) in Article 16, the following point is added:

(da) ensuring the provision of appropriate scientific, technical and administrative support for the HERA Board;"

(6) the following Article 17a is inserted:

"Article 17a

HERA Board

1. The HERA Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights.

2. In addition, two public health experts shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the HERA Board.

3. The members of the HERA Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise, absence of direct or indirect conflict of interest.

4. The term of office for members and their alternates shall be four years. That term may be extendable once consecutively.

5. ECDC Director, a representative of the Health Security Committee and a representative of the European Medicines Agency shall attend the meetings of the HERA Board, as permanent observer. Other relevant EU bodies and agencies may be invited to attend as observers, where relevant.

6. The HERA Board may invite relevant stakeholders to attend the HERA Board meetings as observers. Observers shall declare their interest ahead of each meeting. 7. The HERA Board shall adopt its rules of procedure, including regarding election of a Chair and voting procedures.

8. List of members and alternates, rules of procedure, agendas and minutes shall be made available on the Authority’s website."

(7) the following Article 17b is inserted:

"Article 17a

Tasks of the HERA Board

The HERA Board shall:

(a) adopt the multiannual strategic planning for the Health Emergency Preparedness and Response Authority;

(b) adopt strategic decisions concerning HERA on research and innovation and industrial strategy in the area of antimicrobials and medical countermeasures;

(c) adopt a long-term European portfolio or research and development projects in line with public health priorities set by the Commission in consultation with the World Health Organisation;

(d) ensure scientific and technical management of HERA;

(e) assess the performance of the tasks entrusted to HERA;

(f) contribute to the coherence of Union’s crisis preparedness and response management;

(g) contribute to the coordinated action by the Commission and the Member States for the implementation of the cross-border health threats regulation;

(h) contribute to the implementation of the EU’s Global Health Strategy, in particular in relations of addressing current and emerging health threats;

(i) adopt of opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health, including antimicrobial resistance."

(8) Article 19 is replaced by the following:

"Article 19

Transparency and Conflict of Interest

1. Members of the Management Board, Members of the HERA Board, members of the scientific panels, members of the Advisory Committee, Executive Director and staff shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests which shall be made publicly available on the Agency’s website. They shall not have any direct or indirect financial or other interests in the pharmaceutical or other medical industry which could affect their impartiality.

2. The Centre's and Authority’s code of conducts shall provide for the implementation of this Article.

3. The Centre and the Authority shall make available the rules of procedure, agendas, minutes and members of the structures referred to in paragraph 1 and their declarations of interest on their website.

4. Stakeholders invited to meetings at the Centre and the Authority shall declare their direct and indirect interest ahead of the meeting."

_________________

1a Even if the Commission stated that a new incentives should only reward the highest level of innovation, the actual criteria that was outlined in the voucher art. 40 was written in a way that would allow the Voucher to be awarded to more incremental type of innovation (such as betalactamase inhibitors). While such follow-on innovation on existing classes of antibiotics (e.g., overcoming a particular resistance mechanism in one type of bacteria, or development of a specific patient formulation (pediatrics for example), or dose-optimisation or reducing side effects) can of course have clinical benefit, if they meet a particular urgent need, and therefore should be supported. But it is important that it is on a much smaller scale. To get the truly new antibiotics we need new incentive schemes that are big but also have very high innovation threshold. Otherwise, we will end up overpaying for incremental innovation and developers will not go for the far more difficult to develop antibiotics we urgently need.

Or. en

Justification

ECDC is the closest in terms of mandate to include a new structure that would deal with addressing health threats and particularly AMR. In its enhanced mandate, the EP also pushed through a review clause that the mandate could be enlarged to NCDs one day. Such option ensured lower administrative and financial burden than establishing a completely new agency. This options is consistent with the wish of the EP to have HERA independent from the Commission as well as with the priority to have a stronger ECDC. The proposal is built on multiple studies and materials including from the Commission and STOA.

Amendment 1894

Tilly Metz

Proposal for a regulation

Article -176 (new)

Regulation (EU) 2021/522

Article 8a

Text proposed by the Commission

Amendment

Article-176

Amendments to Regulation (EU) 2021/522

Regulation (EU) 2021/522 is amended as follows:

(1) the following Article 8a is inserted:

"Article 8a

The EU Antimicrobial Innovation Fund

1. The EU Antimicrobial Innovation Fund is hereby established.

2. The Fund invests in the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account any equivalent list of priority pathogens adopted at Union level.

3. The Fund shall also support the development and finance procurement and of rapid diagnostic tools to ensure prudent use of existing antimicrobials.

4. The Fund shall generate and invest at least 1 billion EUR per year, from the following sources:

(a) EU4Health Programme, including through allocated financial penalties to pharmaceutical industry for the absence of antimicrobial R&D as established in Article 172 of [Revised Regulation 726/2004] allocated to the programme;

(b) external assigned revenue, including:

(i) allocations from Horizon Europe Programme;

(ii) voluntary contribution from philanthropic funds and other international funding schemes.

(iii) voluntary contributions from Member States.

5. Investments shall prioritise areas that can reduce the costs of R&D for new antimicrobials, including the establishment of global clinical trials networks and clinical trials conducted through non-for-profit organisations.

6. All allocation of resources from the fund shall be transparent and subject to affordability and availability conditions and the principle of open science."

Or. en

Justification

EU4Health already foresees:

Annex I: Supporting actions to encourage the development of innovative medicinal products and vaccines to meet rising healthcare challenges and patients’ needs, and of less commercially profitable products such as antimicrobials;

Amendment 1895

Tomislav Sokol

Proposal for a regulation

Article 176 – paragraph 1 – point 2 a (new)

Text proposed by the Commission

Amendment

(2 a) The following Article is inserted under Chapter 2:

"Article 8a

Regulatory sandboxes

1.Where a regulatory sandbox is established by the Commission in accordance with Article 113(6) of [revised Regulation (EC) 726/2004] for developing or testing a product that may be regulated as an advanced therapy medicinal product, Articles 113 to 115 of [revised Regulation (EC) 726/2004] shall apply.

2. In accordance with Article 115(3) of [revised Regulation (EC) 726/2004], the modalities and the conditions of the operation of such regulatory sandboxes, including the eligibility criteria and the procedure for application, selection, participation and exiting from the sandbox, and the rights and obligations of the participants shall be set out in implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 5 of Regulation (EU) No 182/2011."

Or. en

Amendment 1896

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 177 – paragraph 1 – point 1

Regulation (EU) 536/2014

Article 5a – paragraph 3

Text proposed by the Commission

Amendment

3. Articles 6 to 11 of Directive 2001/18/EC shall not apply to investigational medicinal products for human use containing or consisting of genetically modified organisms.

3. The paragraph 3 is amended as follows:

"Articles 6 to 11 of Directive 2001/18/EC shall not apply to investigational medicinal products for human use containing or consisting of genetically modified organisms.

By derogation from paragraphs 1 and 2, where the sponsor can demonstrate the absence or low environmental risks from the investigational medicinal products for human use containing or consisting of GMOs, the sponsor shall not be required to conduct the assessment prior to commencement of clinical trials. For this purpose, the criteria and Annex established by delegated act referred to in paragraph 9 shall apply."

Or. en

Justification

harmonization

Amendment 1897

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 177 – paragraph 1 – point 1

Regulation (EU) 536/2014

Article 5a

Text proposed by the Commission

Amendment

The following subparagraph 4 a (new) is inserted in Article 5 a - paragraph 8:

"The delegated act referred to in the first subparagraph shall establish the specific criteria the purpose of paragraph 3 of this Article. The delegated act referred to in the first subparagraph shall include an annex laying down a list of well-characterised investigational medicinal products containing or consisting of GMOs that do not survive in the environment for the purpose of paragraph 3 of this Article."

Or. en

Justification

harmonization

Amendment 1898

Tomislav Sokol

Proposal for a regulation

Article 177 – paragraph 1 – point 8 a (new)

Text proposed by the Commission

Amendment

(8 a) the following Article 90a is inserted:

"Article 90a

Regulatory sandboxes

1.Where a regulatory sandbox is established by the Commission in accordance with Article 113(6) of [revised Regulation (EC) 726/2004] for developing or testing a product that may be regulated as a medicinal product, Articles 113 to 115 of [revised Regulation (EC) 726/2004] shall apply.

Or. en

Amendment 1899

Tomislav Sokol

Proposal for a regulation

Article 177 – paragraph 1 – point 9 a (new)

Text proposed by the Commission

Amendment

(9 a) In Annex II, Section A, the following paragraph (1a) is inserted:

"Where an application for authorisation of a substantial modification of a clinical trial is already under review by the Member States concerned, sponsors can submit a new application for authorisation of another substantial modification for that same trial before the previous application is authorised, and the new application can be validated, assessed and processed in parallel to the assessment of the first application. The cover letter of the second application shall include a reference to other open procedure application(s) under review."

Or. en

Amendment 1900

Tomislav Sokol

Proposal for a regulation

Article 177 – paragraph 1 – point 9 b (new)

Text proposed by the Commission

Amendment

(9 b) The following Article 3a is inserted:

"Article 3a

Medicinal products containing, consisting of or derived from substances of human origin

"When Substance of Human Origins (SoHO) as defined in [SoHO Regulation] are used to manufacture investigational medicinal products and advanced therapy medicinal products containing, consisting of or derived from SoHOs, regulated by this Regulation, relevant provisions of [SoHO Regulation] shall apply to SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients."

Or. en

Amendment 1901

Tomislav Sokol

Proposal for a regulation

Article 178 a (new)

Text proposed by the Commission

Amendment

Article178a

Article 178a Amendments to Regulation (EU) No 2017/745

Regulation (EU) No 2017/745 is amended as follows:

The following Article 4a is inserted:

“Article 4a

Regulatory sandboxes

1. Where a regulatory sandbox is established by the Commission in accordance with Article 113(6) of [revised Regulation (EC) 726/2004] for developing or testing a product that may be regulated as a medical device, Articles 113 and 115 of [revised Regulation (EC) 726/2004] shall apply.

3. Following consultations with the Member States, the Agency, and other Union competent authorities and bodies, the Commission shall be empowered to adopt delegated acts in accordance with Article 115 to lay down specific rules (including derogations from the requirements set out in this Regulation) which may apply to medical devices which were developed as part of a regulatory sandbox.”

Or. en

Amendment 1902

Tomislav Sokol

Proposal for a regulation

Article 178 b (new)

Text proposed by the Commission

Amendment

Article178b

Article 178b Amendments to Regulation (EU) No 2017/746

Regulation (EU) No 2017/746 is amended as follows:

The following Article 3a is inserted:

“Article 3a

Regulatory sandboxes

1. Where a regulatory sandbox is established by the Commission in accordance with Article 113(6) of [revised Regulation (EC) 726/2004] for developing or testing a product that may be regulated as an in-vitro diagnostic medical device, Articles 113 and 115 of [revised Regulation (EC) 726/2004] shall apply.

3. Following consultations with the Member States, the Agency, and other Union competent authorities and bodies, the Commission shall be empowered to adopt delegated acts in accordance with Article 108 to lay down specific rules (including derogations from the requirements set out in this Regulation) which may apply to in-vitro diagnostic medical devices which were developed as part of a regulatory sandbox.”

Or. en

Amendment 1903

Tilly Metz

Proposal for a regulation

Article 180 – paragraph 13

Text proposed by the Commission

Amendment

13. By way of derogation from Article [Duration of application of Chapter III] vouchers granted until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with Chapter III, whichever date is the earliest, shall continue to be valid according to the conditions set out in Chapter III.

deleted

Or. en

Amendment 1904

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 180 – paragraph 13

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1905

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 180 – paragraph 13

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1906

Fulvio Martusciello

Proposal for a regulation

Article 180 – paragraph 13 a (new)

Text proposed by the Commission

Amendment

13 a. Sectoral Annexes on Pharmaceutical Good Manufacturing Practices (GMP) in Agreements on Mutual Recognition between the Union and third countries shall continue to apply unless and until repealed.

Or. en

Amendment 1907

Tomislav Sokol

Proposal for a regulation

Article 181 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The provisions in Chapter III shall apply from the entry into force of this Regulation.

Or. en

Amendment 1908

Pernille Weiss

Proposal for a regulation

Annex I – point 3

Text proposed by the Commission

Amendment

3. Medicinal products for human use containing an active substance which on 20 May 2004 was not authorised in the Union, excluding allergen products or herbal medicinal products, which shall in any case not be authorised by the Union.

3. Medicinal products for human use containing an active substance which on 20 May 2004 was not authorised in the Union, excluding herbal medicinal products, which shall in any case not be authorised by the Union.

Or. en

Amendment 1909

Edina Tóth

Proposal for a regulation

Annex II – point 8 a (new)

Text proposed by the Commission

Amendment

(8 a) The obligation to make the product available as laid out in the availability plan set out in the marketing authorization.

Or. en

Justification

In order to ensure that centrally authorized medicinal products are made available in every member states it is important that the marketing authorization provides for the necessary modalities. The establishment of such modalities can take several forms in order the best accommodate the needs of the specific member states. For example the marketing authorization holder can undertake to place the product physically on the market, submit a pricing and reimbursement application or commit itself that in case individual request the product is made available to the patient without any delay that would risk the success of the therapy. The availability plan should be assessed by the Committee for Medicinal Products for Human Use and if needed adapted Such obligation should be enforced via Union penalties referred to in Article 172.

Amendment 1910

Tilly Metz

Proposal for a regulation

Annex II – point 16

Text proposed by the Commission

Amendment

(16) the obligation to conduct post-marketing studies, including post-authorisation safety studies and post-authorisation efficacy studies, and to submit them for review, as provided for in Article 20;

(16) the obligation to conduct post-marketing studies, including post-authorisation safety studies, post-authorisation efficacy studies and post-authorisation environmental risk assessment studies, and to submit them for review, as provided for in Article 20;

Or. en

Amendment 1911

Maria Angela Danzì

Proposal for a regulation

Annex II – point 25 a (new)

Text proposed by the Commission

Amendment

(25a) the obligation to notify the competent authority of the Member State and, where relevant, the Agency about cessation, withdrawal or temporary suspension for the durations set out in Article 116;

Or. it

Justification

The Regulation should impose penalties for non-compliance with the most important measures concerning shortages of medicines and security of supply.

Amendment 1912

Tilly Metz

Proposal for a regulation

Annex II – point 25 a (new)

Text proposed by the Commission

Amendment

(25 a) the supply obligations related to the availability and security of supply as laid down in Chapter X of this Regulation.

Or. en

Amendment 1913

Tilly Metz

Proposal for a regulation

Annex II – point 25 b (new)

Text proposed by the Commission

Amendment

(25 b) the obligations to report on public financial support and research and development costs as laid down in Article 57 and 57a of [revised Directive 2001/83/EC]

Or. en

Justification

Generally, Annex II should be amended after political deal reached on obligations for MAH in the operative text of the Regulation and Directive

Amendment 1914

Maria Angela Danzì

Proposal for a regulation

Annex II – point 25 b (new)

Text proposed by the Commission

Amendment

(25b) the obligation to have in place and keep up to date a shortage prevention plan as provided for in Article 117;

Or. it

Justification

The Regulation should impose penalties for non-compliance with the most important measures concerning shortages of medicines and security of supply.

Amendment 1915

Maria Angela Danzì

Proposal for a regulation

Annex II – point 25 c (new)

Text proposed by the Commission

Amendment

(25c) the obligation to comply with the recommendations and measures taken in case of a serious shortage as provided for in Article 125;

Or. it

Justification

the obligation to comply with the recommendations and measures taken in case of a serious shortage as provided for in Article 125;

Amendment 1916

Maria Angela Danzì

Proposal for a regulation

Annex II – point 25 d (new)

Text proposed by the Commission

Amendment

(25 d) the obligation to comply with the recommendations and measures taken in relation to critical medicinal products as provided for in Article 133.

Or. it

Justification

The Regulation should impose penalties for non-compliance with the most important measures concerning shortages of medicines and security of supply.

Amendment 1917

Tilly Metz

Proposal for a regulation

Annex II – point 25 d (new)

Text proposed by the Commission

Amendment

(25 d) the obligations related to penalty payments to the EU Antimicrobial Innovation Fund.

Or. en

Amendment 1918

Andrey Slabakov

Proposal for a regulation

Annex IV – Part I – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

For the purpose of the notification in accordance with Article 116(1), points (a), (b) and (c), the marketing authorisation holder shall notify the following minimum set of information:

For the purpose of the notification in accordance with Article 116(1), points (a), (b) and (c), the marketing authorisation holder shall notify the following minimum set of information, reusing where possible prepopulated information from previous regulatory processes and from other existing IT systems:

Or. en

Amendment 1919

Tilly Metz

Proposal for a regulation

Annex IV – Part I – paragraph 1 – point 1 – point l a (new)

Text proposed by the Commission

Amendment

(l a) information on available alternatives, where available.

Or. en

Amendment 1920

Andrey Slabakov

Proposal for a regulation

Annex IV – Part II – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

For the purpose of the request made by the competent authority concerned in accordance with Article 118(2), the marketing authorisation holder shall notify at least the following information:

For the purpose of the request made by the competent authority concerned in accordance with Article 118(2), the marketing authorisation holder shall notify at least the following information, reusing where possible prepopulated information from previous regulatory processes and from other existing IT systems:

Or. en

Amendment 1921

Andrey Slabakov

Proposal for a regulation

Annex IV – Part III – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

For the purpose of the notification in accordance with Article 116(1), point (d) the marketing authorisation holder shall notify the following information:

For the purpose of the notification in accordance with Article 116(1), point (d) the marketing authorisation holder shall notify the following information, reusing where possible prepopulated information from previous regulatory processes and from other existing IT systems:

Or. en

Amendment 1922

Tiemo Wölken

Proposal for a regulation

Annex IV – Part III – paragraph 1 – point 2 – point e

Text proposed by the Commission

Amendment

(e) Reason for shortage;

(e) Reason for shortage including information on;

(i) raw material disruption, due to…

(ii ) API disruption, due to…

(iii) excipient disruption, due to…

(iv) production problem, due to..

(v) quality problem, due to…

(vi) production capacity, due to…

(vii) logistics problem, due to…

(viii) distribution problem, due to…

(ix) inventory and storage practices

(x) increase in demand

(xi) commercial reasons

Or. en

Amendment 1923

Cyrus Engerer

Proposal for a regulation

Annex IV – Part III – paragraph 1 – point 2 – point e

Text proposed by the Commission

Amendment

(e) Reason for shortage;

• raw material disruption, due to…

• API disruption, due to…

• excipient disruption, due to…

• production problem, due to..

• quality problem, due to…

• production capacity, due to…

• logistics problem, due to…

• distribution problem, due to…

• inventory and storage practices

• increase in demand

• commercial reasons

Or. en

Amendment 1924

Tilly Metz

Proposal for a regulation

Annex IV – Part IV – paragraph 1 – point 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) methodology for establishing a demand forecast;

Or. en

Amendment 1925

Cyrus Engerer

Proposal for a regulation

Annex IV – Part V – paragraph 1 – point 1 – point k a (new)

Text proposed by the Commission

Amendment

(k a) quantities delivered each year per Member State in previous 5 years

Or. en

Amendment 1926

Tilly Metz

Proposal for a regulation

Annex IV – Part V – paragraph 1 – point 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) methodology for establishing a demand forecast.

Or. en

Amendment 1927

Kateřina Konečná

Proposal for a regulation

Annex IV – Part V – paragraph 1 – point 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) process for establishing the demand forecast.

Or. en