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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Amendment 632

Margarita de la Pisa Carrión

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The applicant shall submit an environmental risk assessment referred to in Article 7(1) to the Agency.

The applicant shall submit an environmental risk assessment referred to in Article 7(1) to the Agency and will be answer in a limit time of period.

Or. en

Amendment 633

Tilly Metz

Proposal for a regulation

Article 9 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Committee for Medicinal Products for Human Use shall assess the environmental risk assessment.

The Committee for Medicinal Products for Human Use shall establish an Environmental Risk Assessment Working Party and assess the environmental risk assessment.

Or. en

Amendment 634

Edina Tóth

Proposal for a regulation

Article 9 a (new)

Text proposed by the Commission

Amendment

Article9a

Availability plan

1. The The applicant shall submit an availability plan to the Agency. The availability plan shall describe the modalities by which the authorised medicinal product is made available during the period of regulatory data protection or patent, in a Member States where the medicinal product is needed. applicant shall submit an availability plan to the Agency. The availability plan shall describe the modalities by which the authorised medicinal product is made available during the period of regulatory data protection or patent, in a Member States where the medicinal product is needed.

2. The Committee for Medicinal Products for Human Use shall assess the availalibility plan and request modification thereto, if it comes to the conclusion that the foreseen modalities do not guarantee timely access to patients. In case of such a request the applicant shall adjust the availability plan.

Or. en

Amendment 635

Andrey Slabakov

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

2. Where within 90 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as withdrawn.

Or. en

Amendment 636

Susana Solís Pérez

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

2. Where within 90 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a reasonable time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as refused.

Or. en

Amendment 637

Tomislav Sokol

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

2. Where within 60 days of the validation of the marketing authorisation application and during the assessment the Committee for Medicinal Products for Human Use considers that the submitted data are not of sufficient quality or maturity to complete the assessment, the assessment can be terminated. The Committee for Medicinal Products for Human Use shall summarise the deficiencies in writing. On this basis, the Agency shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the Agency, the application shall be considered as withdrawn.

Or. en

Amendment 638

Stelios Kympouropoulos

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Justification

The proposed amendment aims to the alignment with FDA timeline and to a more efficient use of the Agency resources.

Amendment 639

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 640

Kateřina Konečná

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 641

Tiemo Wölken

Proposal for a regulation

Article 10 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 642

Alessandra Moretti

Proposal for a regulation

Article 12 – paragraph 4 – point h

Text proposed by the Commission

Amendment

(h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies to improve the safe and effective use of the medicinal product;

(h) where appropriate, details of any recommended obligation to conduct post-authorisation treatment optimisation studies to improve the safe and effective use of the medicinal product; Such an obligation to conduct such studies shall take into account the scientific guidance referred to in Article 123 of [revised Directive 2001/83/EC];

Or. en

Amendment 643

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

Proposal for a regulation

Article 12 – paragraph 4 – point h

Text proposed by the Commission

Amendment

(h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies to improve the safe and effective use of the medicinal product;

(h) where appropriate, details of any recommended obligation to conduct any other post-authorisation studies, including post-authorisation treatment optimisation studies, to improve the safe and effective use of the medicinal product;

Or. en

Amendment 644

Kateřina Konečná

Proposal for a regulation

Article 12 – paragraph 4 – point i

Text proposed by the Commission

Amendment

(i) in case of medicinal products for which there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, a post-authorisation obligation to substantiate the clinical benefit;

(i) in case of medicinal products for which, on duly justified grounds described in the assessment report, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, with particular attention to new active substances and therapeutic indications, a post-authorisation obligation to substantiate the clinical benefit;

Or. en

Amendment 645

Tilly Metz

Proposal for a regulation

Article 12 – paragraph 4 – point i

Text proposed by the Commission

Amendment

(i) in case of medicinal products for which, on duly justified ground submitted to the Agency, there is uncertainty as to the surrogate endpoint relation to the expected health outcome, where appropriate and relevant for the benefit-risk balance, a post-authorisation obligation to substantiate the clinical benefit;

Or. en

Justification

Approving products based on surrogate endpoints is far from ideal as there is no evidence as to the added clinical benefit, however, in certain cases it might be the only option. Nevertheless, it should not be regarded as a norm but rather as an exception and it should always be justified why more solid evidence were not provided EUNet HTA guidelines further stress that ‘only a few surrogate outcomes have shown to be true measures of tangible clinical benefit and they have rarely established in a rigorous manner’

Amendment 646

Frédérique Ries

Proposal for a regulation

Article 12 – paragraph 4 – point i

Text proposed by the Commission

Amendment

(i) in case of medicinal products for which there is substantial uncertainty as to the surrogate endpoint relation to the expected health outcome, where patient-centered, hard or validated surrogate trial endpoints - including survival and quality of life - that are well defined in the study protocol and can be measured objectively are not possible, and where appropriate and relevant for the benefit-risk balance, a post-authorisation obligation to substantiate the clinical benefit;

Or. en

Amendment 647

Tilly Metz

Proposal for a regulation

Article 12 – paragraph 4 – point i a (new)

Text proposed by the Commission

Amendment

(i a) justification in case marketing authorisation was granted where no comparative data with a standard-of-care active comparator were submitted;

Or. en

Amendment 648

Tilly Metz

Proposal for a regulation

Article 12 – paragraph 4 – point j a (new)

Text proposed by the Commission

Amendment

(j a) where appropriate any justified reasoning for granting marketing authorisation pursuant to Article 18, 19 and 30 of this Regulation;

Or. en

Amendment 649

Tilly Metz

Proposal for a regulation

Article 12 – paragraph 4 – point m

Text proposed by the Commission

Amendment

(m) where appropriate, to carry out medicinal product-specific validation studies to replace animal-based control methods with non-animal-based control methods.

(m) to carry out medicinal product-specific validation studies to replace animal-based control methods with non-animal-based control methods.

Or. en

Amendment 650

Tilly Metz

Proposal for a regulation

Article 12 – paragraph 4 – point m a (new)

Text proposed by the Commission

Amendment

(m a) for antimicrobials, the stewardship plan referred to in Article 17 and information materials referred to in Article 69 of [revised Directive 2001/83/EC] as well as any related obligations imposed on the marketing authorisation holder.

Or. en

Amendment 651

Andrey Slabakov

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Within 12 days of receipt of the opinion of the Committee for Medicinal products for Human Use the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 173(1) a draft of the decision on the application.

Or. en

Amendment 652

Tomislav Sokol

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Within 6 days of receipt of the opinion of the Committee for Medicinal products for Human Use the Commission shall submit to the Standing Committee on Medicinal Products for Human Use referred to in Article 173(1) a draft of the decision on the application.

Or. en

Amendment 653

Margarita de la Pisa Carrión

Proposal for a regulation

Article 13 – paragraph 1 – subparagraph 6 a (new)

Text proposed by the Commission

Amendment

The Standing Committee on Medicinal Products for Human Use shall give its opinion in writing. Member States shall forward their written observations on the draft decision to the Commission within 10 days.

Or. en

Amendment 654

Tomislav Sokol

Proposal for a regulation

Article 13 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, take a final decision within 12 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173, paragraphs 2 and 3.

2. The Commission shall, by means of implementing acts, take a final decision within 6 days after obtaining the opinion of the Standing Committee on Medicinal Products for Human Use. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 173, paragraphs 2 and 3.

Or. en

Amendment 655

Margarita de la Pisa Carrión

Proposal for a regulation

Article 13 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Commission decision-making phase shall not exceed 30 days from the date of CHMP opinion.

Or. en

Justification

The Commission decision making procedure should be reduced toa maximum of 30 days for new products and be removed from variation procedures to increase efficiency. The Commission proposal of a maximum of 46 days for the Commission decision-making phase is commensurate with current times in practice. This decision-making phase is a significant contributor tothe average time lag of 6 months between EU and US for example. Furthermore, for 11 recently authorised oncolog yproducts, over 7,000 years of potential life lost could have beens aved with a reduction from 46 to 30 days2.Reg recital 49 and Dir recital 146 will also need to be amended asstates ‘…the final decision on the application for a marketing authorisation should in principle be no longer than 46 days.’ and‘… the final decision on any Commission Decision concerning national marketing authoristions, in particular for referrals, shouldbe reduced to, in principle, 46 days.’ Respectively.’

Amendment 656

Stanislav Polčák

Proposal for a regulation

Article 14 – paragraph 1

Text proposed by the Commission

Amendment

If an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly available and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature.

If an applicant withdraws an application for a marketing authorisation submitted to the Agency before an opinion has been given on the application by the Committee for Medicinal Products for Human Use, the applicant shall communicate its reasons for doing so to the Agency. The Agency shall make this information publicly available and shall publish the assessment report, if available, after deletion of all information of a commercially confidential nature.

Or. cs

Amendment 657

Tilly Metz

Proposal for a regulation

Article 14 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, based on the opinion of the Agency, withdraw marketing authorisation of medicinal product where emerging scientific evidence concludes any serious associated risk to human or public health, where the marketing authorisation holder fails to fulfill the obligations regarding post authorisation studies referred to in paragraph 1 of Article 20 or where the unmet need status is no longer justified.

Or. en

Amendment 658

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 659

Tomislav Sokol

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 660

Marian-Jean Marinescu

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Introducing the possibility to refuse a marketing authorisation based on environmental grounds would negatively impact patient’s access to medicines. Increase of administrative burden as environment protection obligations for companies are already established in other various EU legislation

Amendment 661

Pernille Weiss

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

See amendment to Article 15 – paragraph 1 a (new).

Amendment 662

Margarita de la Pisa Carrión

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 663

Andrey Slabakov

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the environmental risk assessment is incomplete;

Or. en

Amendment 664

Fulvio Martusciello

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the content or timelines of post-authorisation studies to further clarify environmental risk assessment, as required in article 20(c), cannot be agreed.

Or. en

Amendment 665

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) there is no agreement on the content or timing of post-authorisation studies to further explain environmental risk assessment, as stated by article 20(c).

Or. en

Amendment 666

Stanislav Polčák

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment are not being sufficiently addressed by the applicant;

Or. cs

Amendment 667

Erik Poulsen

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant in cases where the medicinal product does not qualify for conditional marketing authorization or the Temporary Emergency Marketing Authorization;

Or. en

Amendment 668

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

Proposal for a regulation

Article 15 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant, with the exception of medicinal products authorised before 30 october 2005 to avoid restricting patients’ access to existing treatments;

Or. en

Amendment 669

Tomislav Sokol

Proposal for a regulation

Article 15 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the content or timelines of post-authorisation studies to further clarify environmental risk assessment, as required in Article 20(c), cannot be agreed.

Or. en

Amendment 670

Margarita de la Pisa Carrión

Proposal for a regulation

Article 15 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the content or timelines of post-authorisation studies to further clarify environmental risk assessment, as required in article 20(c), cannot be agreed.

Or. en

Justification

Initial marketing authorisation refusal based on environmental risk assessment science which can in some cases only be refined using data collected post marketing, where the scientific consensus has not been developed yet (e.g. antimicrobial resistance) or where highly conservative assumptions are used, is not appropriate. It would strengthen the collection of data and advancement of environmental risk assessment science to promote high quality post-approval commitments which are binding and time constrained.Furthermore, for expedited submissions (e.g. PRIME) or where late indication changes alter the patient population, data on environmental risks may not be available and should not restrict access to patients.

Amendment 671

Sirpa Pietikäinen

Proposal for a regulation

Article 15 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) there is an equivalent product on the market with less negative environmental impacts.

Or. en

Amendment 672

Pernille Weiss

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The marketing authorisation may furthermore be refused if, after verification of the particulars and documentation submitted in accordance with Article 6, the view is taken that the environmental risk assessment is incomplete or insufficiently substantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant.

Or. en

Justification

See amendment to Article 15 – paragraph 1 – point d.

Amendment 673

Alessandra Moretti

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, including information of a commercially confidential nature if their disclosure is in the public interest or relevant for public health reasons.

Or. en

Amendment 674

Tomislav Sokol

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature. Before the publishment of the assessment report, the Agency shall firstly notify patients´ organisations about the outcomes of the report.

Or. en

Amendment 675

Kateřina Konečná

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature unless there is an overriding public interest in disclosure.

Or. en

Amendment 676

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature and following consultation of patients’ organisations.

Or. en

Amendment 677

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

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for its opinion in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature and subsequent consultation of patient organisations.

Or. en

Amendment 678

Stanislav Polčák

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall immediately publish the assessment report on the medicinal product for human use and the reasons for the opinion of the Committee for Medicinal Products for Human Use in favour of granting marketing authorisation, after deletion of any information of a commercially confidential nature.

Or. cs

Amendment 679

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 2 – indent 2

Text proposed by the Commission

Amendment

– a summary of environmental risk assessment studies and their results as submitted by the marketing authorisation holder and the assessment of the environmental risk assessment and the information referred to in Article 22(5) of [revised Directive 2001/83/EC] by the Agency.

Or. en

Amendment 680

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)

Text proposed by the Commission

Amendment

– for antimicrobials, the stewardship plan referred to in Article 17 and information materials referred to in Article 69 of [revised Directive 2001/83/EC], as well as any related obligations imposed on the marketing authorisation holder.

Or. en

Amendment 681

Andrey Slabakov

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 2 – indent 2 a (new)

Text proposed by the Commission

Amendment

– a summary of any rewards and incentives granted.

Or. en

Amendment 682

Kateřina Konečná

Proposal for a regulation

Article 16 – paragraph 3 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

When the medicinal product is an antimicrobial, the Agency shall publish the information referred to in Article 17 of [revised Directive 2001/83/EC], as well as any obligations imposed on the marketing authorisation holder if it finds the risk mitigation measures contained in the stewardship plan unsatisfactory.

Or. en

Amendment 683

Marian-Jean Marinescu

Proposal for a regulation

Article 16 – paragraph 4 – subparagraph 2 – point c

Text proposed by the Commission

Amendment

(c) a potential or actual shortage in that Member State in accordance with Article 116(1), point (d); and its reasons for such action under points (a) and (b) in accordance with Article 24, as well as any other reason relating to precautionary actions with regard to quality, safety, efficacy and the environment.

(c) a potential or actual shortage in that Member State in accordance with Article 116(1), point (d); and its reasons for such action under points (a) and (b) in accordance with Article 24 and the cause of shortage under point (c) , as well as any other reason relating to precautionary actions with regard to quality, safety, efficacy and the environment.

Or. en

Justification

Identifying the causes of shortages and the responsibilities are crucial for future preventive actions.

Amendment 684

Kateřina Konečná

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to paragraph 2, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

1. A marketing authorisation for a medicinal product shall be valid for five years; the marketing authorisation may be renewed after five years on the basis of a re-evaluation of the risk-benefit balance by Agency.

Or. en

Amendment 685

Alessandra Moretti

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to paragraph 2, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

1. A marketing authorisation for a medicinal product shall be valid for five years and might be renewed on the basis of a re-evaluation of the risk-benefit balance by the Agency.

Or. en

Amendment 686

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to paragraph 2, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

1. Marketing authorisation for a medicinal product shall be valid for five years.

Or. en

Amendment 687

Kateřina Konečná

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. By way of derogation from the first subparagraph, the marketing authorisation for the medicinal products described in Article 9 of [revised Directive 2001/83/EC] shall be valid for an unlimited period.

Or. en

Amendment 688

Kateřina Konečná

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from paragraph 1, the Commission may decide when granting an authorisation, on the basis of a scientific opinion by the Agency concerning the safety of the medicinal product, to limit the validity of the marketing authorisation to five years.

deleted

Or. en

Amendment 689

Alessandra Moretti

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 690

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

By way of derogation from paragraph 1, marketing authorisation for products referred to in Article 9 of [revised Directive 2001/83/EC] shall be valid for an unlimited period.

Or. en

Amendment 691

Alessandra Moretti

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Where the validity of the marketing authorisation is limited to five years, the marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.

the marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.

Or. en

Amendment 692

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Where the validity of the marketing authorisation is limited to five years, as laid down in paragraph 1, the marketing authorisation holder shall apply to the Agency for a renewal of the marketing authorisation at least nine months before the marketing authorisation ceases to be valid.

Or. en

Amendment 693

Alessandra Moretti

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Where a renewal application has been submitted in accordance with the second subparagraph, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

Where a renewal application has been submitted, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

Or. en

Amendment 694

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

Where a renewal application has been submitted in accordance with the first subparagraph, the marketing authorisation shall remain valid until a decision is adopted by the Commission in accordance with Article 13.

Or. en

Amendment 695

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 4

Text proposed by the Commission

Amendment

The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period.

The marketing authorisation may be renewed on the basis of a re-evaluation by the Agency of the benefit-risk balance. Once renewed, the marketing authorisation shall be valid for an unlimited period unless the Agency decides, on justified grounds, to proceed with one additional five-year renewal.

Or. en

Amendment 696

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. By way of derogation from paragraphs 1 and 2, marketing authorisation for a medicinal product shall be withdrawn if the review of the post-authorisation studies referred to in paragraph 1 of Article 20 result in a negative risk-benefit assessment.

Or. en

Amendment 697

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:

1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety, and, where missing, on the environmental risk of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:

Or. en

Amendment 698

Tomislav Sokol

Proposal for a regulation

Article 18 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:

Or. en

Amendment 699

Margarita de la Pisa Carrión

Proposal for a regulation

Article 18 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. In exceptional circumstances where, in an application under Article 6 of [revised Directive 2001/83/EC] for a marketing authorisation of a medicinal product or a new therapeutic indication including when grouped with an extension of an existing marketing authorisation under this Regulation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the Commission may, by derogation to Article 6, grant an authorisation under Article 13, subject to specific conditions, where the following requirements are met:

Or. en

Amendment 700

Tomislav Sokol

Proposal for a regulation

Article 18 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The maintenance of the authorised new therapeutic indication and the validity of the marketing authorisation granted in accordance with paragraph 1 shall be linked to the reassessment by the Agency of the conditions referred to in paragraph 1 after two years from the date when the new therapeutic indication was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the Agency and specified by the Commission in the marketing authorisation.

The maintenance of the authorised new therapeutic indication, including when grouped with an extension of the marketing authorisation, and the validity of the marketing authorisation granted in accordance with paragraph 1 shall be linked to the reassessment by the Agency of the conditions referred to in paragraph 1 after two years from the date when the new therapeutic indication, including when grouped with an extension of the marketing authorisation, was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the Agency and specified by the Commission in the marketing authorisation.

Or. en

Amendment 701

Margarita de la Pisa Carrión

Proposal for a regulation

Article 18 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The maintenance of the authorised new therapeutic indication including when grouped with an extension of the marketing authorisation and the validity of the marketing authorisation granted in accordance with paragraph 1 shall be linked to the reassessment by the Agency of the conditions referred to in paragraph 1 after two years from the date when the new therapeutic indication was authorised or the marketing authorisation was granted, and thereafter at a risk-based frequency to be determined by the Agency and specified by the Commission in the marketing authorisation.

Or. en

Amendment 702

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication or renew the marketing authorisation under exceptional circumstances.

This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication, renew the marketing authorisation under exceptional circumstances or issue a negative marketing authorisation opinion and withdraw the product from the market.

Or. en

Amendment 703

Tomislav Sokol

Proposal for a regulation

Article 18 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

This reassessment shall be conducted on the basis of an application by the marketing authorisation holder to maintain the authorised new therapeutic indication, including when grouped with an extension of the marketing authorisation, or renew the marketing authorisation under exceptional circumstances.

Or. en

Amendment 704

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Before granting an authorisation pursuant to paragraph 1, the Agency shall publish in the product’s assessment report a justification for granting marketing authorisation under this Article and explain why an authorisation pursuant to Article 19 is deemed unsuitable.

Or. en

Amendment 705

Tomislav Sokol

Proposal for a regulation

Article 19 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

In duly justified cases, to meet an unmet medical need of patients, as referred to in Article 83(1), point (a), of [revised Directive 2001/83/EC], a conditional marketing authorisation or a new conditional therapeutic indication to an existing marketing authorisation authorised under this Regulation may be granted by the Commission to a medicinal product that is likely to address the unmet medical need in accordance with Article 83(1), point (b), of [revised Directive 2001/83/EC], prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of that medicinal product outweighs the risk inherent in the fact that additional data are still required.

In duly justified cases, to meet an unmet medical need of patients, as referred to in Article 83(1), point (a) and (2), of [revised Directive 2001/83/EC], a conditional marketing authorisation or a new conditional therapeutic indication, including when grouped with an extension of existing marketing authorisation authorised under this Regulation may be granted by the Commission to a medicinal product that is likely to address the unmet medical need in accordance with Article 83(1), point (b), of [revised Directive 2001/83/EC], prior to the submission of comprehensive clinical data provided that the benefit of the immediate availability on the market of that medicinal product outweighs the risk inherent in the fact that additional data are still required.

Or. en

Amendment 706

Tomislav Sokol

Proposal for a regulation

Article 19 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

In emergency situations, a conditional marketing authorisation or a new conditional therapeutic indication referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.

In emergency situations, a conditional marketing authorisation or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.

Or. en

Amendment 707

Margarita de la Pisa Carrión

Proposal for a regulation

Article 19 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

In emergency situations, a conditional marketing authorisation or a new conditional therapeutic indication including when grouped with an extension of the marketing authorisation referred to in the first subparagraph may be granted also where comprehensive non-clinical or pharmaceutical data have not been supplied.

Or. en

Amendment 708

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 19 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 709

Tomislav Sokol

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Conditional marketing authorisations or a new conditional therapeutic indication referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data.

2. Conditional marketing authorisations or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data.

Or. en

Amendment 710

Margarita de la Pisa Carrión

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Conditional marketing authorisations or a new conditional therapeutic indication including when grouped with an extension of the marketing authorisation referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant is likely to be able to provide comprehensive data.

Or. en

Amendment 711

Tilly Metz

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Conditional marketing authorisations or a new conditional therapeutic indication referred to in paragraph 1 may be granted only if the benefit-risk balance of the medicinal product is favourable and the applicant commits to provide comprehensive data within the agreed time-frame .

Or. en

Amendment 712

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed every 3 months by the Agency for the first year after granting the authorisation and every month thereafter. A conditional marketing authorisation cannot exceed 2 years.

Or. en

Amendment 713

Kateřina Konečná

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and in particular for the studies mentioned in paragraph 4 the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter. Real world evidence, preferably from the EU, shall be submitted by marketing authorisation holder on regular and compulsory basis before granting the renewed conditional marketing authorisation.

Or. en

Amendment 714

Andrey Slabakov

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter. Accurate, comprehensive and up-to-date real world evidence shall be submitted by the marketing authorisation holder on regular basis before granting the renewed conditional marketing authorisation.

Or. en

Amendment 715

Sirpa Pietikäinen

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations, such as the obligation to conduct a post-authorisation environmental risk assessment study. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Or. en

Amendment 716

Tomislav Sokol

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication, including when grouped with an extension of the marketing authorisation, granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Or. en

Amendment 717

Margarita de la Pisa Carrión

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication including when grouped with an extension of the marketing authorisation granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Or. en

Amendment 718

Susana Solís Pérez

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Or. en

Amendment 719

Maria Angela Danzì

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Or. it

Justification

The specific obligations relating to the conditional marketing authorisation are subject to a specific and mandatory deadline. Since the conditional marketing authorisation is granted before the submission of the full clinical data, it is essential to confirm, within a reasonable timeframe, that the risk-benefit balance favourable.

Amendment 720

Tilly Metz

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Conditional marketing authorisations or a new conditional therapeutic indication granted pursuant to this Article shall be subject to specific obligations. Those specific obligations and, the time limit for compliance shall be specified in the conditions to the marketing authorisation. Those specific obligations shall be reviewed annually by the Agency for the first three years after granting the authorisation and every two years thereafter.

Or. en

Amendment 721

Kateřina Konečná

Proposal for a regulation

Article 19 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall, in accordance with Article 172, impose financial penalties to the marketing authorisation holder for unjustified situations of non-compliance with specific obligations, in particular for delays in the submission of study results.

Or. en

Amendment 722

Kateřina Konečná

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit-risk balance is favourable. The Agency shall lay down deadlines and criteria for the fulfilment of these conditions and make them publicly available. The holder of a conditional marketing authorisation shall respond to a Member State’s call for negotiation and conclusion of a risk-sharing or managed entry agreement when such institute is required for making the medicinal product available to patients in the Member State.

Or. en

Amendment 723

Tilly Metz

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

4. As part of the specific obligations referred to in paragraph 3, the marketing authorisation holder of a conditional marketing authorisation granted pursuant to this Article shall be required to complete ongoing studies, or to conduct new studies, with a view to confirming that the benefit-risk balance is favourable. Information on concrete commitments, timelines, status and, where applicable, justifications for any delays, for the product-specific obligations shall be made publicly available and easily accessible on EMA’s website.

Or. en

Amendment 724

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

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 725

Andrey Slabakov

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 726

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 727

Tomislav Sokol

Proposal for a regulation

Article 19 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Agency shall lay down criteria for the fulfilment of these conditions and make them publicly available.

Or. en

Amendment 728

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 19 – paragraph 6

Text proposed by the Commission

Amendment

6. By way of derogation from Article 17(1), an initial conditional marketing authorisation granted pursuant to this Article shall be valid for one year, on a renewable basis for the first three years after granting the authorisation and every two years thereafter.

deleted

Or. en

Amendment 729

Tilly Metz

Proposal for a regulation

Article 19 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. Where the specific conditions referred to in paragraph 3 have not been fulfilled, the Commission may, after having received a negative opinion from the Agency, withdraw the product from the market.

Or. en

Amendment 730

Tilly Metz

Proposal for a regulation

Article 19 – paragraph 8 – point b

Text proposed by the Commission

Amendment

(b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, and for adding a new conditional therapeutic indication to an existing marketing authorisation.

(b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, for adding a new conditional therapeutic indication to an existing marketing authorisation , and for product withdrawal.

Or. en

Amendment 731

Tomislav Sokol

Proposal for a regulation

Article 19 – paragraph 8 – point b

Text proposed by the Commission

Amendment

(b) the procedures and requirements for granting a conditional marketing authorisation, for its renewal, and for adding a new conditional therapeutic indication, or extension to an existing marketing authorisation.

Or. en

Amendment 732

Kateřina Konečná

Proposal for a regulation

Article 19 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. The Agency shall publish in a database the list of conditional marketing authorisations, together with the following information:

(a) specific obligations to be fulfilled by the marketing authorisation holder;

(b) timelines for compliance with specific obligations;

(d) any penalties imposed by the Commission on the marketing authorisation holder for non-compliance with the specific obligations, in accordance with Article 172;

(e) any actions on the conditional marketing authorisation taken in accordance with Article 56.

Or. en

Amendment 733

Sirpa Pietikäinen

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) conducts a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product. If the same concerns apply to more than one medicinal product, the Agency shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;

(a) conducts a post-authorisation safety study if there are concerns about the risks of an authorised medicinal product to the environment or to public health. If the same concerns apply to more than one medicinal product, the Agency shall, following consultation with the Pharmacovigilance Risk Assessment Committee, encourage the marketing authorisation holders concerned to conduct a joint post-authorisation safety study;

Or. en

Amendment 734

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) conducts a post-authorisation treatment optimisation study when the optimal usage of medicinal product was not previously established.

Or. en

Amendment 735

Marian-Jean Marinescu

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) submits Treatment optimisation (TO) data to the EMA within certain time limit.

Or. en

Justification

Optimising the use of therapies in clinical practice should produce similar therapeutic benefits but fewer toxicities for patients, while also generating significant cost savings for healthcare systems.

Amendment 736

Marian-Jean Marinescu

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 1 – point c b (new)

Text proposed by the Commission

Amendment

(c b) performs a Treatment optimisation( TO) clinical trial in collaboration with an independent not-for-profit research organisation able to develop and peer-review the clinical trial protocol, and to collect and analyse independently the clinical trial data. The marketing authorisation holder shall provide all relevant information regarding the drug and financial support to the independent non-profit research organisation.

Or. en

Justification

Amendment 737

Tiemo Wölken

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

If this obligation would apply to several medicinal products, the Agency shall encourage the marketing authorisation holders concerned to conduct a joint post authorisation environmental risk assessment study, which shall be designed where possible considering non-animal approaches such as in vitro and in silico methods.

Or. en

Amendment 738

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Where the Agency considers that any of the post-authorisations studies referred to in points (a) to (c) is necessary, it shall inform the marketing authorisation holder thereof in writing, stating the grounds for its assessment and shall include the objectives and timeframe for submission and conduct of the study.

Where the Agency considers that any of the post-authorisations studies referred to in points (a) to (ca) is necessary, it shall inform the marketing authorisation holder thereof in writing, stating the grounds for its assessment and shall include the objectives and timeframe for submission and conduct of the study.

Or. en

Amendment 739

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the opinion of the Agency confirms the need for any of the post-authorisation studies referred to in paragraph 1, points (a) to (c), to be carried out, the Commission shall vary the marketing authorisation, by means of implementing acts, adopted pursuant to Article 13 to include the obligation as a condition of the marketing authorisation unless the Commission returns the opinion to the Agency for further consideration. For obligations under paragraph 1, points (a) and (b), the marketing authorisation holder shall update the risk management system accordingly.

4. Where the opinion of the Agency confirms the need for any of the post-authorisation studies referred to in paragraph 1, points (a) to (ca), to be carried out, the Commission shall vary the marketing authorisation, by means of implementing acts, adopted pursuant to Article 13 to include the obligation as a condition of the marketing authorisation unless the Commission returns the opinion to the Agency for further consideration. For obligations under paragraph 1, points (a) and (b), the marketing authorisation holder shall update the risk management system accordingly.

Or. en

Amendment 740

Cyrus Engerer

Proposal for a regulation

Article 22 a (new)

Text proposed by the Commission

Amendment

Article22a

Obligations and liability of the marketing authorisation holder

The marketing authorisation holder of a centralised medicinal product shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products, so that the needs of patients in those Member States in which it is prescribed are covered.

Or. en

Amendment 741

Andreas Glück, Frédérique Ries, Catherine Amalric

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

The granting of a marketing authorisation shall not affect the civil or criminal liability of the manufacturer or of the marketing authorisation holder pursuant to the applicable national law in Member States.

The granting of a marketing authorisation as well as the granting of a temporary emergency marketing authorisation shall not affect the civil or criminal liability of the manufacturer or of the marketing authorisation holder pursuant to the applicable national law in Member States.

Or. en

Justification

The experience during the COVID-19 Pandemic has shown that there should not be any doubts about the liability of marketing authorisation holders.

Amendment 742

Alessandra Moretti

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

In addition to the notification made pursuant to Article 116, the marketing authorisation holder shall notify the Agency without undue delay of any action they take to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action.

In addition to the notification made pursuant to Article 116, the marketing authorisation holder shall notify the Agency in advance about the intention to suspend the marketing of a medicinal product, to withdraw a medicinal product from the market, to request the withdrawal of a marketing authorisation or not to apply for the renewal of a marketing authorisation, together with the reasons for such action, and before any action is taken in this sense.

Or. en

Amendment 743

Marian-Jean Marinescu

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f

Text proposed by the Commission

Amendment

(f) a serious risk to the environment or to public health via the environment has been identified and not sufficiently addressed by the marketing authorisation holder.

deleted

Or. en

Justification

Introducing the possibility to withdraw a marketing authorisation based on environmental grounds would negatively impact patient’s access to medicines

Amendment 744

Susana Solís Pérez

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(f a) a decision driven by commercial considerations, while safeguarding any information that is of a commercially confidential nature.

Or. en

Amendment 745

Maria Angela Danzì

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(fa) a decision based on commercial grounds, without prejudice to any commercially-confidential information.

Or. it

Justification

Many medicinal products are withdrawn from the market for commercial reasons. That information should be made available to the regulatory authorities and the public.

Amendment 746

Kateřina Konečná

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(f a) commercial reasons.

Or. en

Justification

When marketing authorisation holders withdraw medicines from the market for commercial reasons (e.g., pricing strategies or other) they should be transparent about it.

Amendment 747

Tilly Metz

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(f a) commercial reasons.

Or. en

Amendment 748

Alessandra Moretti

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(f a) commercial reasons;

Or. en

Amendment 749

Dolors Montserrat

Proposal for a regulation

Article 24 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Where the action referred to in the first subparagraph is to withdraw a medicinal product from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated.

Where the action referred to in the first subparagraph is to withdraw a medicinal product with no alternative therapeutic equivalent from the market, the marketing authorisation holder shall provide information on the impact of such withdrawal on patients who are already being treated.

Or. en

Amendment 750

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 24 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Following the receipt of a notification of the suspension of a medicinal product's marketing issued pursuant to Article 116, the competent authority of the Member State where the medicinal product was marketed can recommend increasing the prices of products for which a risk of shortages or market consolidation has been identified.

Or. fr

Amendment 751

Tilly Metz

Proposal for a regulation

Article 24 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. In the cases referred to in paragraph 1 point (f), the competent authorities shall forward the information to drinking water and wastewater operators.

Or. en

Amendment 752

Susana Solís Pérez

Proposal for a regulation

Article 24 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a critical medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that critical medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC].

When a marketing authorization is transferred to a new holder, such change shall be reported to the Agency within a 30-day timeframe and include the financial details of the transaction between the transferring parties. This information shall be made accessible to the public by the Agency.

Or. en

Amendment 753

Maria Angela Danzì

Proposal for a regulation

Article 24 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the marketing authorisation holder intends to permanently withdraw the marketing authorisation for a medicinal product, the marketing authorisation holder shall, prior to the notification referred to in paragraph 1, offer, on fair and reasonable terms, to transfer the marketing authorisation to a third party that has declared its intention to place that medicinal product on the market, or to use the pharmaceutical non-clinical and clinical documentation contained in the file of the medicinal product for the purposes of submitting an application in accordance with Article 14 of [revised Directive 2001/83/EC].

A marketing authorisation holder to whom a marketing authorisation is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall publish that information.

Or. it

Justification

One issue that particularly affects less profitable markets in the Member States is the interruption in supply, or withdrawal, of effective medicinal products. These practices are liable not only to hamper fair access to medicinal products for all EU citizens and lead to shortages of such products, but also to Member States finding themselves in different positions when it comes to prices. The possibility to continue production and supply should apply to all medicinal products, and not just those deemed to be critical under this Regulation.

Amendment 754

Kateřina Konečná

Proposal for a regulation

Article 24 – paragraph 4

Text proposed by the Commission

Amendment

The competent authority of the Member State may extend the obligation referred to in the first subparagraph to a marketing authorisation holder that intends to permanently withdraw the marketing authorisation for a non-critical medicinal product.

Or. en

Amendment 755

Tilly Metz

Proposal for a regulation

Article 24 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The national competent authority of the Member State may decide to extend obligations set in paragraph 4 to a specific non-critical medicinal product on a case by case basis.

Or. en

Amendment 756

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

Proposal for a regulation

Article 25 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a) if one of its indications or pharmaceutical forms is protected by a patent or a supplementary protection certificate in one or more Member States;

(a) if one of its indications, posologies, pharmaceutical forms, methods or routes of administration or any other element is protected by a patent or a supplementary protection certificate in one or more Member States;

Or. en

Amendment 757

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

Proposal for a regulation

Article 25 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall withdraw the initial or duplicate marketing authorisation or where appropriate vary the term of the marketing authorisation to include the relevant SmPC information for which the corresponding patent(s) or supplementary protection certificate(s) has(ve) expired.

Or. en

Amendment 758

Andrey Slabakov

Proposal for a regulation

Article 25 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

As soon as the relevant patent or supplementary protection certificate referred to in point (a) expires, the marketing authorisation holder shall, without undue delay, withdraw the initial or duplicate marketing authorisation.

Or. en

Amendment 759

Cyrus Engerer

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.

2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a group of patients with a chronically or seriously debilitating disease whose physical or mental health disease is considered to be life-threatening, treatment resistant, or causing psychological distress in palliative care, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.

Or. en

Amendment 760

Tomislav Sokol

Proposal for a regulation

Article 26 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of this Article, ‘compassionate use’ shall mean making a medicinal product belonging to the categories referred to in Article 3, paragraphs 1 and 2 available for compassionate reasons to a group of patients or a single patient with a chronically or seriously debilitating disease or whose disease is considered to be life-threatening, and who cannot be treated satisfactorily by an authorised medicinal product. The medicinal product concerned must either be the subject of an application for a marketing authorisation in accordance with Article 6 or the submission of such application is imminent, or it must be undergoing clinical trials in the same indication.

Or. en

Amendment 761

Tomislav Sokol

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. When applying paragraph 1, the Member State shall notify the Agency.

3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.

Or. en

Amendment 762

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

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. When applying paragraph 1, the Member State shall notify the Agency.

3. When applying paragraph 1, the Member State shall notify the Agency, which shall make the notification publicly available.

Or. en

Amendment 763

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. When applying paragraph 1, the Member State shall notify the Agency.

3. When applying paragraph 1, the Member State shall notify the Agency which shall make the notification publicly available.

Or. en

Amendment 764

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 26 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

When compassionate use is envisaged by a Member State, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated where necessary.

When compassionate use is envisaged by a Member State, or by the applicant or sponsor, the Committee for Medicinal Products for Human Use, after consulting the manufacturer or the applicant, may adopt opinions on the conditions for use, the conditions for distribution and the patients targeted. The opinions shall be updated where necessary.

Or. en

Amendment 765

Anders Vistisen

on behalf of the ID Group

Proposal for a regulation

Article 26 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 766

Catherine Amalric, Max Orville, Erik Poulsen, Andreas Glück, Ondřej Knotek

Proposal for a regulation

Article 26 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, where available, taking into account the reliability of those data.

In the preparation of the opinion, the Committee for Medicinal Products for Human Use may request information and data from marketing authorisation holders and from developers and may engage with them in preliminary discussions. The Committee may also make use of health data generated outside of clinical studies, including real world data, where available, taking into account the reliability of those data.

Or. en

Amendment 767

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website.

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a centralized database for compassionate use programs on its website.

Or. en

Amendment 768

Tomislav Sokol

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website.

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.

Or. en

Amendment 769

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website.

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.

Or. en

Amendment 770

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

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website.

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it in a central repository for compassionate use on its website.

Or. en

Amendment 771

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 26 – paragraph 6

Text proposed by the Commission

Amendment

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website.

6. The Agency shall keep an up-to-date list of the opinions adopted in accordance with paragraph 4 and shall publish it on its website in an accessible, searchable data format.

Or. en

Amendment 772

Andrey Slabakov

Proposal for a regulation

Article 26 – paragraph 10

Text proposed by the Commission

Amendment

10. The Agency may adopt detailed guidelines laying down format and content of notifications referred to in paragraphs 3 and 5, and data exchange under this Article.

10. The Agency shall adopt detailed guidelines laying down format and content of notifications referred to in paragraphs 3 and 5, and data exchange under this Article.

Or. en

Amendment 773

Stanislav Polčák

Proposal for a regulation

Article 28 – title

Text proposed by the Commission

Amendment

Regulatory decisions on marketing authorisations

The binding nature of this Regulation with regard to marketing authorisations

Or. cs

Amendment 774

Alessandra Moretti

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. Marketing authorisation holders that benefit from regulatory protection shall disclose information on actual costs of research and development in accordance with Article 84a of the aforementioned Directive.

Or. en

Amendment 775

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

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. The granting of periods of regulatory protection shall be published and updated where appropriate by the Agency in a designated registry.

Or. en

Amendment 776

Andrey Slabakov

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the law on the protection of industrial and commercial property, medicinal products for human use which have been authorised in accordance with this Regulation shall benefit from the periods of regulatory protection set out in Chapter VII of [revised Directive 2001/83/EC]. The granting of periods of regulatory protection shall be published and updated by the Agency in a designated registry.

Or. en

Amendment 777

Kateřina Konečná

Proposal for a regulation

Article 29 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Marketing authorisation holders that benefit from regulatory protection shall disclose information on research and development costs in accordance with Article 84a of the aforementioned Directive.

Or. en

Amendment 778

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Chapter II – Section 3

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 779

Stanislav Polčák

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

During a public health emergency, the Commission may grant a temporary emergency marketing authorisation (‘TEMA’) for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information. However, prior to the submission of a full environmental risk assessment as referred to in Article 7(1), a temporary emergency authorisation may only be granted if the best available scientific information indicates that there is no risk of serious or irreversible harm to the environment, animals or human health arising from the manufacture or use of the medicinal product containing or consisting of the GMO.

Or. cs

Amendment 780

Kateřina Konečná

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

During a public health emergency, the Commission may, following an application by a developer, grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information.

Or. en

Amendment 781

Tomislav Sokol

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

During a public health emergency, the Commission may, following an application by a developer grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information.

Or. en

Amendment 782

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

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

During a public health emergency, the Commission may grant a temporary emergency marketing authorisation (‘TEMA’) or a new temporary emergency therapeutic indication, including when grouped with an extension of an existing marketing authorisation under this Regulation, for medicinal products intended for the treatment, prevention or medical diagnosis of a serious or life-threatening disease or condition which are directly related to the public health emergency, prior to the submission of the complete quality, non-clinical, clinical data and environmental data and information.

Or. en

Amendment 783

Tomislav Sokol

Proposal for a regulation

Article 30 – paragraph 3

Text proposed by the Commission

Amendment

An application for a temporary emergency marketing authorisation shall be submitted in accordance with Articles 5 and 6.

deleted

Or. en

Amendment 784

Tomislav Sokol

Proposal for a regulation

Article 30 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Derogations to Articles 5 and 6 of this Regulation may apply in the context of submission of an application for a temporary emergency marketing authorisation.

Or. en

Amendment 785

Tomislav Sokol

Proposal for a regulation

Article 31 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A temporary emergency marketing authorisation may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council67 and where the following requirements are met:

A temporary emergency marketing authorisation or a temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, may be granted only after the recognition of a public health emergency at Union level in accordance with Article 23 of Regulation (EU) 2022/2371 of the European Parliament and of the Council67 and where the following requirements are met:

_________________

67 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 (OJ L 314, 6.12.2022, p. 26).

Or. en

Amendment 786

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

Proposal for a regulation

Article 31 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 787

Kateřina Konečná

Proposal for a regulation

Article 31 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 788

Kateřina Konečná

Proposal for a regulation

Article 31 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation of the medicinal product will contribute to address the public health emergency;

(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation or new temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;

Or. en

Amendment 789

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

Proposal for a regulation

Article 31 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation or temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;

Or. en

Amendment 790

Tomislav Sokol

Proposal for a regulation

Article 31 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) there is no other satisfactory method of treatment, prevention or diagnosis authorised or sufficiently available in the Union or, if such method is already available, the temporary emergency marketing authorisation or temporary emergency therapeutic indication of the medicinal product, including when grouped with an extension of the marketing authorisation, will contribute to address the public health emergency;

Or. en

Amendment 791

Tilly Metz

Proposal for a regulation

Article 31 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential risks of the product, taking into consideration the threat posed by the public health emergency.

(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the benefits of the product outweigh the risks of the product, taking into consideration the threat posed by the public health emergency.

Or. en

Amendment 792

Kateřina Konečná

Proposal for a regulation

Article 31 – paragraph 1 – point b

Text proposed by the Commission

Amendment

The Agency shall ensure that expectations of benefits are plausible.

Or. en

Justification

Given that at the time of decision on trial some adverse drug reactions will not have been detected in the studies conducted on the product, it makes sense to consider ‘potential risks’. However, considering ‘potential benefits’ could open the door to exaggerating the products’ efficacy, something that would greatly alter its benefit/risk balance. To ensure that the TMA scheme has enough safeguards, the Regulation should stress that expectations of benefits should be plausible.

Amendment 793

Sirpa Pietikäinen

Proposal for a regulation

Article 31 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) based on the scientific evidence available, the Agency issues an opinion concluding that the medicinal product could be effective in treating, preventing or diagnosing the disease or condition directly related to the public health emergency, and the known and potential benefits of the product outweigh the known and potential environmental and health risks of the product, taking into consideration the threat posed by the public health emergency.

Or. en

Amendment 794

Tomislav Sokol

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

1. The Agency shall ensure that the scientific opinion of the Committee for Medicinal Products for Human Use is given without undue delay, taking into account, the recommendation of the Emergency Task Force referred to in Article 38(1), second subparagraph. For the purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal product concerned.

1. The Agency shall ensure that the scientific opinion of the Committee for Medicinal Products for Human Use is given to the applicant without undue delay, taking into account, the recommendation of the Emergency Task Force referred to in Article 38(1), second subparagraph. For the purpose of issuing its opinion, the Agency may consider any relevant data on the medicinal product concerned in addition to the evidence submitted in the applicant’s dossier.

Or. en

Amendment 795

Tomislav Sokol

Proposal for a regulation

Article 32 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency shall review any new evidence provided by the developer, the Member States or the Commission, or any other evidence that comes to its attention, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned.

The Agency shall review any new evidence provided by the applicant, the Member States or the Commission, or any other evidence of sufficient quality that comes to its attention in addition to and in the context of evidence submitted by the applicant, in particular evidence that might influence the benefit-risk balance of the medicinal product concerned.

Or. en

Amendment 796

Tomislav Sokol

Proposal for a regulation

Article 32 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency shall update its scientific opinion as necessary.

Following consultation with the applicant, the Agency shall update its scientific opinion as necessary.

Or. en

Amendment 797

Tilly Metz

Proposal for a regulation

Article 32 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation.

3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation. The scientific opinion and information on the application on the use of temporary emergency marketing authorisation shall be made publicly available by the Agency.

Or. en

Amendment 798

Kateřina Konečná

Proposal for a regulation

Article 32 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation.

3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation or new temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation.

Or. en

Amendment 799

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

Proposal for a regulation

Article 32 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation.

3. The Agency shall transmit without undue delay to the Commission the scientific opinion and its updates and any recommendations on the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation.

Or. en

Amendment 800

Tomislav Sokol

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. On the basis of the scientific opinion of the Agency referred to in paragraph 1, the Commission shall set specific conditions with respect to the temporary emergency marketing authorisation, in particular the conditions for manufacturing, use, supply and safety monitoring and the compliance with related good manufacturing, and pharmacovigilance practices. If necessary, the conditions may specify the batches of the medicinal product concerned by the temporary emergency marketing authorisation.

Or. en

Amendment 801

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

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 802

Tilly Metz

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. Specific conditions may be set to require the completion of ongoing studies or to conduct new studies to ensure the safe and effective use of the medicinal product or minimise its impact on the environment. A time limit for the submission of those studies shall be set.

3. Specific conditions shall be set to require the completion of ongoing studies or to conduct new studies to ensure the safe and effective use of the medicinal product or minimise its impact on the environment. A time limit for the submission of those studies shall be set.

Or. en

Amendment 803

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

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency.

4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency, in consultation with the applicant or marketing authorisation holder.

Or. en

Amendment 804

Tomislav Sokol

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Those specific conditions and, where appropriate, the time limit for compliance shall be specified in the conditions to the marketing authorisation and shall be reviewed annually by the Agency.

Or. en

Amendment 805

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

Proposal for a regulation

Article 34 – paragraph 1

Text proposed by the Commission

Amendment

The temporary emergency marketing authorisation shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.

The temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, shall cease to be valid when the Commission terminates the recognition of a public health emergency in accordance with Article 23(2) and (4) of Regulation (EU) 2022/2371.

Or. en

Amendment 806

Tomislav Sokol

Proposal for a regulation

Article 34 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 807

Kateřina Konečná

Proposal for a regulation

Article 34 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 808

Tomislav Sokol

Proposal for a regulation

Article 34 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. When the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with first subparagraph of this Article, a transitional period shall be set by the Agency in agreement with the marketing authorisation holder in order to avoid any disruption in supply of the medicinal product concerned.

Or. en

Amendment 809

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

Proposal for a regulation

Article 34 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. When the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with paragraph 1 of this Article, the Agency may set a transitional period after consultation with the marketing authorisation holder in order to avoid any disruption in supply of the medicinal product concerned.

Or. en

Amendment 810

Kateřina Konečná

Proposal for a regulation

Article 34 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Without prejudice to Article 37, when the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, ceases to be valid in accordance with paragraph 1 of this Article, a transitional period shall be set by the Agency in order to avoid any disruption in supply of the medicinal product concerned.

Or. en

Amendment 811

Stanislav Polčák

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) it is appropriate to protect public health;

(b) it is appropriate to protect public health or the environment;

Or. cs

Amendment 812

Kateřina Konečná

Proposal for a regulation

Article 35 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) a marketing authorization is granted in accordance with Article 36, subparagraph 1.

Or. en

Amendment 813

Tomislav Sokol

Proposal for a regulation

Article 35 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Where the Commission adopts any such implementing act, the provisions of Article 34, paragraph 1a shall apply.

Or. en

Amendment 814

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

Proposal for a regulation

Article 35 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Where the Commission adopts any such implementing act, the provisions of Article 34, paragraph 1a shall apply.

Or. en

Amendment 815

Tilly Metz

Proposal for a regulation

Article 36 – paragraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder of an authorisation in accordance with Article 33 may submit an application in accordance with Articles 5 and 6 in order to obtain an authorisation in accordance with Articles 13, 16 or 19.

The marketing authorisation holder of an authorisation in accordance with Article 33 shall submit an application in accordance with Articles 5 and 6 in order to obtain an authorisation in accordance with Articles 13, 16 or 19 based on the pre-agreed timelines established with the Agency.

Or. en

Amendment 816

Kateřina Konečná

Proposal for a regulation

Article 36 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

To ensure a smooth administrative conversion of the temporary marketing authorization referred under Article 33 into a marketing authorisation under Articles 13, 16 or 19 according to paragraph 1, and in order to avoid any disruption in availability on the market of the medicinal products concerned, a transitional period shall be set by the Agency.

Or. en

Amendment 817

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

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

For the purpose of regulatory data protection, the temporary emergency marketing authorisation and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.

For the purpose of regulatory data protection, the temporary emergency marketing authorisation or temporary emergency therapeutic indication, including when grouped with an extension of the marketing authorisation, and any subsequent marketing authorisation, as referred to in subparagraph 1, shall be considered as part of the same global marketing authorisation.

Or. en

Amendment 818

Tomislav Sokol

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 819

Tomislav Sokol

Proposal for a regulation

Article 37 – paragraph 1

Text proposed by the Commission

Amendment

When the temporary marketing authorisation of a medicinal product is suspended or revoked for reasons other than the safety of the medicinal product, or if that temporary emergency marketing authorisation ceases to be valid, Member States may, in exceptional circumstances, allow for a transitional period, the supply of the medicinal product to patients who are already being treated with it.

deleted

Or. en

Amendment 820

Tilly Metz

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’

III deleted

Or. en

Justification

The Greens/EFA proposal recalls back the wish of the European Parliament to establish an independent EU BARDA. The proposal is based on the policy scenarios assessed by the Panel for the Future of Science and Technology (STOA), namely studies ‘Could public infrastructure overcome market failures?’ and ‘Improving access to medicines and promoting pharmaceutical innovation’See amendments to Chapter xix article 175a onwards

Amendment 821

Maria Angela Danzì

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’

III ADDRESSING PHARMACEUTICAL MARKET FAILURES IN THE UNION AND GREATER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF PRIORITY ANTIMICROBIALS

Or. it

Amendment 822

Andrey Slabakov

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III INCENTIVES FOR THE DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’

III ADDRESSING PHARMACEUTUCAL MARKET FAILURES IN THE UNION AND FURTHER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF ‘PRIORITY ANTIMICROBIALS’

Or. en

Amendment 823

Tiemo Wölken

Proposal for a regulation

Chapter III a (new)

Text proposed by the Commission

Amendment

III a ADDRESSING PHARMACEUTUCAL MARKET FAILURES IN THE UNION AND FURTHER INCENTIVES FOR THE RESEARCH AND DEVELOPMENT OF PRIORITY ANTIMICROBIALS

SECTION 1 TASKS OF THE AGENCY

Or. en

Amendment 824

Maria Angela Danzì

Proposal for a regulation

Article 40

Text proposed by the Commission

Amendment

Article 40

deleted

Granting the right to a transferable data exclusivity voucher

1. Following a request by the applicant when applying for a marketing authorisation, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics:

(a) it represents a new class of antimicrobials;

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.

To be granted the voucher by the Commission, the applicant shall:

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

Within 30 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.

Or. it

Justification

The development of antimicrobials should be supported by other types of incentive, such as direct financial incentives.

Amendment 825

Kateřina Konečná

Proposal for a regulation

Article 40

Text proposed by the Commission

Amendment

Article 40

deleted

Granting the right to a transferable data exclusivity voucher

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

(a) it represents a new class of antimicrobials;

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

To be granted the voucher by the Commission, the applicant shall:

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

Or. en

Justification

Transferable data exclusivity vouchers raise significant concerns. Firstly, it is not clear to what extent they will ensure access to new antimicrobials that are placed on the market. Transferable data exclusivity vouchers are a one-off reward, which does not guarantee that companies will launch these new antimicrobials in all Member States or that they will continue to market them in the future. In addition, there is a strong likelihood that pharmaceutical companies will apply the voucher granted for the development of a new antibiotic to their most profitable products.

Amendment 826

Alessandra Moretti

Proposal for a regulation

Article 40

Text proposed by the Commission

Amendment

Article 40

deleted

Granting the right to a transferable data exclusivity voucher

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

(a) it represents a new class of antimicrobials;

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

To be granted the voucher by the Commission, the applicant shall:

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

Or. en

Amendment 827

Tilly Metz

Proposal for a regulation

Article 40

Text proposed by the Commission

Amendment

Article 40

deleted

Granting the right to a transferable data exclusivity voucher

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

(a) it represents a new class of antimicrobials;

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

To be granted the voucher by the Commission, the applicant shall:

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

Or. en

Amendment 828

Frédérique Ries, Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 40

Text proposed by the Commission

Amendment

Article 40

deleted

Granting the right to a transferable data exclusivity voucher

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

(a) it represents a new class of antimicrobials;

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

To be granted the voucher by the Commission, the applicant shall:

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

Or. en

Amendment 829

Catherine Amalric, Max Orville

Proposal for a regulation

Article 40 – title

Text proposed by the Commission

Amendment

Granting the right to a transferable data exclusivity voucher

Creating a Union scheme of incentives

Or. en

Amendment 830

Andrey Slabakov

Proposal for a regulation

Article 40 – title

Text proposed by the Commission

Amendment

Granting the right to a transferable data exclusivity voucher

Granting the right to a transferable data exclusivity voucher as a short-term measure of addressing Antimicrobial Resistance

Or. en

Amendment 831

Sara Cerdas

Proposal for a regulation

Article 40 – title

Text proposed by the Commission

Amendment

Granting the right to a transferable data exclusivity voucher

Granting the right to a transferable accelerated assessment procedure voucher

Or. en

Justification

The accelerated assessment procedure voucher consists in a variant of the Priority Review Voucher (PRV) in the context of a mechanism already in place by the European Medicines Agency, namely, the accelerated procedure for marketing authorisation. The PRV has been applied in the US successfully since 2007 for neglected tropical diseases, such as dengue, and tuberculosis, with adherence by the industry. The accelerated assessment procedure voucher bases on the same principles of the PRV, however applied to antimicrobials as it is a negleted disease in the EU regarding the development of new effective medicinal products. In contrary to the US, which the PRV is charged double the fee for the marketing authorisation procedure, to make this a true incentive to AMR, I believe that the reduced time-limit for the assessment procedure does not necessarily means that an increase to the fee needs to be charged to the applicant.

Amendment 832

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish a Union scheme of push and pull incentives to promote and accelerate the development of new priority antmicrobials and the access to existing and new antimicrobials. This scheme shall be financed through public reasearch funding and benefit from Union programmes. Member States shall also be encouraged to participate to the Union scheme. The Union scheme shall be coordinated by the Commission, through DG HERA.

Or. en

Amendment 833

Sara Cerdas

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. Following a request by the applicant when applying for a marketing authorisation, the Commission may, by means of implementing acts, grant a transferable accelerated assessment procedure voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency under Article 6(7). The fee applied in the context of the accelerated assessment procedure voucher for a marketing authorisation application under the Article 6(3) shall not be subject to any increment, payable to the Agency for the examination of the application.

Or. en

Justification

Amendment 834

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. Following a request by the applicant for a marketing authorisation , made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency or alternatively incentives already introduced in other areas such as rare diseases.

Or. en

Amendment 835

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. Following a request by the applicant when applying for a marketing authorisation, made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.

Or. en

Amendment 836

Tomislav Sokol

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. Following a request by the applicant for a marketing authorisation, made before that marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.

Or. en

Amendment 837

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. Following a request by the applicant for a marketing authorisation, made before the marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.

Or. en

Justification

The proposed amendments to this article aims to further clarify when a request for a transferable exclusivity voucher (TEV) can be undertaken to the EU-commission. A request should be able to be made at any time during the time the marketing authorization is under consideration and not be required to have a request made the same time as the application for marketing authorization is submitted to the EMA (as the original wording is implying). In addition, the key focus should be, while determining the priority status of antimicrobials, on evaluating their effectiveness and clinical benefit against resistance. Since it is important to ensure a robust and science-based evaluation, the Agency should establish an expert group and early dialogues to be conducted with developers. This would ensure a comprehensive assessment process with emphasis on the clinical benefits of the antimicrobials for subject matter.

Amendment 838

Catherine Amalric, Max Orville

Proposal for a regulation

Article 40 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The Commission is empowered to adopt delegated acts in accordance with Article 175 to define further the Union scheme and its funding.

Or. en

Amendment 839

Catherine Amalric, Max Orville

Proposal for a regulation

Article 40 – paragraph 2

Text proposed by the Commission

Amendment

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

deleted

Or. en

Amendment 840

Sara Cerdas

Proposal for a regulation

Article 40 – paragraph 2

Text proposed by the Commission

Amendment

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

2. If the Committee for Medicinal Products for Human Use accepts the request, the voucher referred to in paragraph 1 shall give the right to its applicant to an accelerated assessment procedure for one medicinal product application. In this case, the time-limit laid down in Article 6(7), second subparagraph, shall be reduced to 120 days.

Or. en

Justification

Giving 12 additional months of data protection for one authorised medicinal product means that a pharmaceutical company will chose to attribute it to a medicinal product with a high revenue and which data protection is about to expire. I believe that the consumer and Member States reimbursing consumers will not be benefited from this since they will keep paying a high price for an authorised medicinal product and in the future for the antimicrobial. This "double" expense is unnecessary. Therefore, adopting the accelerated assessment procedure does not pose any additional public spending on any medicinal product. To make this a true incentive for AMR, I suggest to reduce the time of assessment of 180 days. However, the previous regulated assessment time was of 210 days and the previous accelerated assessment procedure time was 150 days. As we wish companies to invest in antimicrobials faster than we do for other innovative drugs due to the global health emergency, a reduced time less of 150 is needed. The proportion of days with the new time would be 128 days, so 120 comes as a suggestion.

Amendment 841

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 2

Text proposed by the Commission

Amendment

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional period of data protection for one authorised medicinal product as set out according to paragraph 3 of this Article.

Or. en

Amendment 842

Marian-Jean Marinescu

Proposal for a regulation

Article 40 – paragraph 2

Text proposed by the Commission

Amendment

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product.

2. The voucher referred to in paragraph 1 shall give the right to its holder to an additional 12 months of data protection for one authorised medicinal product, if the medicinal product is released and continuously supplied into the supply chain in a sufficient quantity and in the presentations necessary to cover the needs of the patients in all Member States in which the marketing authorisation is valid.

Or. en

Justification

Increase patients ‘access to antimicrobials

Amendment 843

Margarita de la Pisa Carrión

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant through advances in current antibiotics or through new emerging mechanisms of action.

Or. en

Amendment 844

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance.

Or. en

Amendment 845

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance.

Or. en

Amendment 846

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance;

Or. en

Justification