Sittings · Document

Draft opinion (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)) 2023-11-21

Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

Committee on the Environment, Public Health and Food Safety

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AM_Com_LegOpinion

Amendment 418

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared indicentally and exceptionally on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Or. en

Amendment 419

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

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner and a hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Or. en

Amendment 420

Margrete Auken

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the professional responsibility of a medical practitioner and hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Or. en

Amendment 421

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’).

Or. en

Amendment 422

István Ujhelyi

Proposal for a directive

Article 2 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. For the purpose of this Article, ‘non-routine basis’ means an advanced therapy medicinal product prepared under hospital exemption on an exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product available, nor an ongoing relevant clinical trial or compassionate use programme for the same indication with an advanced therapy medicinal product for which the patient is eligible. Standardised or repetitive processes, as well as major production planning in advance, which can be considered industrial and beyond what is needed to address the immediate clinical needs of individual patients, will be the indications that an activity occurs on a routine basis. The European Medicines Agency will be the deciding body to establish whether a process is on a routine or non-routine basis, and will do so in close consultation with the competent Member State authority and stakeholders, including representatives of hospital exemption approval holders, industry, and patients.

Or. en

Amendment 423

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 2 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Whenever a hospital exemption exceeds preparation on a non-routine basis, holders of this exemption are granted a transition period of 5 years to obtain a centralised marketing authorisation for the advanced therapy medicinal product under the hospital exemption. For the duration of this transition period, the holder may exceed preparation on non-routine basis in order to guarantee patient access. Member States shall ensure that the use remains focused on unmet medical needs in situations when similar treatment is not available and/or affordable.

Or. en

Amendment 424

István Ujhelyi

Proposal for a directive

Article 2 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The manufacturing of an advanced therapy medicinal product prepared under hospital exemption shall require an approval by the competent authority of the Member State (‘hospital exemption approval’). Member States shall provide a copy of any such approval, as well as subsequent changes, to the Agency. The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located. An approval shall be subject to re-evaluation every year, taking into account the data submitted in accordance with paragraph 4, the completeness and reliability of these data, and other relevant information. An approval shall not be maintained when the conditions under paragraph 1 are not fulfilled any more.

Or. en

Amendment 425

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located.

The approval shall be based on a risk-benefit assessment and be compliant with the conditions and definitions under this Article.

The approval shall be valid for no longer than one year and may be extended only following an assessment of whether the hospital exemption approval is still required to meet special individual patient needs, including if either no centrally authorised product or no adequate clinical trial option or compassionate use program has been made available in the Union since the grant of the hospital exemption approval, and if the manufacturing of such product does not result in any one of the conditions highlighted in the definition of non-routine basis in paragraph 1, over the course of the year.

The Commission, by means of implementing acts, may supplement the details of the application for the approval or renewal of hospital exemption referred to in this Article

Or. en

Amendment 426

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located.

Approval will be contingent on an evaluation of the risks and benefits, in complicance with the requirements and interpretations provided in this Article.Such approval will not exceed a one-year term and can only be renewed after a thorough review to confirm the ongoing necessity of the hospital exemption for individual patient requirements.This includes verifying the continued absence of any centrally approved product, suitable clinical trial, compassionate use program, or other regulated options within the EU since the original approval was granted, and ensuring that the production of the product remains infrequent as specified in this article.

The Commission is empowered to elaborate on the particulars of submitting and updating applications for hospital exemption approval as delineated in this Article, through implementing acts.

Or. en

Amendment 427

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The application for a hospital exemption approval shall be submitted to the competent authority of the Member State where the hospital is located.

The approval shall be valid for no longer than one year and may be extended only following an assessment of whether the hospital exemption approval is still required to meet special individual patient needs, including if either no centrally authorised product, compassionate use programme as referred to in referred to in Article 26 of [revised Regulation 726/2004] or no adequate clinical trial option has been made available [in the Union] since the grant of the hospital exemption approval

Or. en

Amendment 428

Maria Angela Danzì

Proposal for a directive

Article 2 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet medical needs, if preparation on a non-routine basis is maintained. Competent authorities should share with each other information on hospital exemption approvals and the evidence used for such approvals upon request. In case of deviations between national laws, the authorities of the importing country should indicate that these deviations are acceptable. Requirements in Article 2(3-6) should be maintained.

Or. en

Justification

It is critical to allow cross-border exchange to improve all patients’ access to the therapies they need regardless of where they live, in particular for ultra rare conditions.

Amendment 429

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 2 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Without prejudice to the requirements of Articles 2(3), 2(4), 2,(5) and 2(6), Member States may allow for cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of unmet needs, under the condition that preparation on a non-routine basis is maintained and following approval of the importing Member States' competent authority. Competent authorities should share information on hospital exemption approvals on their territory and upon request also share the evidence used for such approvals after approval of the exemption holder.

Or. en

Amendment 430

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

Proposal for a directive

Article 2 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States may authorise the cross-border exchange of advanced therapy medicinal products prepared under hospital exemption in case of shortages of critical medicines or to ensure the treatment of patients affected by rare diseases, in the absence of other solutions.

Or. en

Amendment 431

Margrete Auken

Proposal for a directive

Article 2 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. By way of derogation from paragraph 1, in case of unmet medical need, Member States may allow for mutual recognition and cross-border exchange of advanced therapy medicinal products prepared under hospital exemption.

Or. en

Amendment 432

Margrete Auken

Proposal for a directive

Article 2 – paragraph 2 d (new)

Text proposed by the Commission

Amendment

2 d. National competent authorities shall provide free of charge scientific advice to the entities developing products under hospital exemption, upon request.

Or. en

Amendment 433

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 [1] respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]. This shall include site inspections and GMP CPF accreditation, as well as traceability and pharmacovigilance plans and the evaluation of the preclinical and clinical data generated by the applicant.

_________________

69 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 1).

Or. en

Amendment 434

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

Proposal for a directive

Article 2 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the good pharmacy preparation practices that are adapted to hospital proceesses and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004].

_________________

Or. en

Amendment 435

Margrete Auken

Proposal for a directive

Article 2 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the good pharmacy preparation practices that are adapted to hospital processes and based on good manufacturing practices and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/200769 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004].

_________________

Or. en

Justification

Industrial Good Manufacturing Practice (GMP) principles are not intended for pharmacy preparations and therefore not suitable for low-volume preparations carried out by hospital pharmacists. ATMP production in pharmacies should follow the principles and guidelines of good pharmacy preparation practices that are based on GMP but adapted to pharmacy practice.

Amendment 436

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that advanced therapy medicinal products prepared under hospital exemption comply with the requirements equivalent to the good manufacturing practices, long-term follow up and traceability for advanced therapy medicinal products referred to in Articles 5 and 15 of Regulation (EC) No 1394/2007 respectively, and with pharmacovigilance requirements equivalent to those provided for at Union level pursuant to [revised Regulation (EC) No 726/2004]

_________________

Or. en

Amendment 437

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall ensure that data on the use, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall set the requirements for the collection and reporting of such data, in a structured and standarized way that allows obtaining more robust, reliable and comparable results and conclusions. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to ensure appropriate reporting mechanisms.

Or. en

Amendment 438

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The data shall include the results of patient follow-up for a sufficient period of time after the administration of the product. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Or. en

Amendment 439

István Ujhelyi

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 440

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The collected data must encompass ongoing monitoring results for an adequate duration following the product's use. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Or. en

Amendment 441

Margarita de la Pisa Carrión

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption, as well as any relevant data from patient follow-up is collected and reported by the hospital exemption, approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Or. en

Amendment 442

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall ensure that data on the use, quality, safety and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Or. en

Amendment 443

Ondřej Knotek, Catherine Amalric, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall ensure that data on the use, safety, quality and the efficacy of advanced therapy medicinal products prepared under hospital exemption is collected and reported by the hospital exemption approval holder to the competent authority of the Member State at least annually. The competent authority of the Member State shall review such data and shall verify the compliance of advanced therapy medicinal products prepared under hospital exemption with the requirements referred to in paragraph 3.

Or. en

Amendment 444

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Competent authorities shall ensure that sufficient scientific and regulatory advice is provided to non-profit and academic institutions in order to assist them through the requirements of the hospital exemption clause. In cases where a product under hospital exemption becomes a suitable candidate to begin a centralized marketing authorization procedure, competent authorities shall assist non-profit and academic institutions also through this authorization process.

Or. en

Amendment 445

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 5

Text proposed by the Commission

Amendment

5. If a hospital exemption approval is revoked due to safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

5. Should the holder of the hospital exemption approval fail to meet the conditions outlined in the preceding paragraphs, the authorization will be withdrawn by the national regulatory authority. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States as well as inform the patient who has received the advanced therapy medicinal product produced under the hospital exemption. Additionally, there should be a notification to the patient who has been administered the advanced therapy medicinal product formulated under the hospital exemption.

Or. en

Amendment 446

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the hospital exemption approval holder has not complied with the requirements referred to in paragraphs 1, 2, 3 and 4, the hospital exemption approval shall be revoked by the competent authority of the Member State. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

Or. en

Amendment 447

Ondřej Knotek, Catherine Amalric, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 5

Text proposed by the Commission

Amendment

5. If a hospital exemption approval is revoked due to safety, quality, or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

Or. en

Amendment 448

Margarita de la Pisa Carrión

Proposal for a directive

Article 2 – paragraph 5

Text proposed by the Commission

Amendment

5. If a hospital exemption approval is revoked due to quality, safety or efficacy concerns the competent authority of the Member States that approved the hospital exemption shall inform the Agency and the competent authorities of the other Member States.

Or. en

Amendment 449

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Amendment 450

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authority of the Member State shall transmit the data related to the use, quality, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, such an EU-wide registry will be obligatory and open to the public, requiring regular updates to remain current and encompass a catalogue of the advanced therapy medicinal products formulated under hospital exemption currently employed in the Union, also specifying instances where such approval has been suspended or revoked.

Or. en

Amendment 451

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data, as well as of information on the authorisation, suspension or withdrawal of hospital exemption approvals, reimbursement prices, and public and private contributions to the development of the product; which shall be updated regularly.

Or. en

Amendment 452

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 453

Margrete Auken

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data, including information on authorisations, suspensions or withdrawals of products under hospital exemption referred to in paragraph 1.

Or. en

Amendment 454

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.

Or. en

Amendment 455

Maria Angela Danzì

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authority of the Member State shall transmit the data related to the use, safety and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a repository of that data. The Agency shall ensure that an overview of approved advanced therapy medicinal products prepared under hospital exemption is made public.

Or. en

Justification

Transparency and insight into available treatments is vital to ensure equitable access across the EU, in particular for ultra rare conditions.

Amendment 456

Ondřej Knotek, Catherine Amalric, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authority of the Member State shall transmit the data related to the use, safety, quality and efficacy of an advanced therapy medicinal product prepared under the hospital exemption approval to the Agency annually. The Agency shall, in collaboration with the competent authorities of Member States and the Commission, set up and maintain a publicly accessible repository of that data in the form of an EU-wide registry.

Or. en

Amendment 457

Margarita de la Pisa Carrión

Proposal for a directive

Article 2 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 458

Margrete Auken

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall adopt implementing acts to specify the following:

The Commission shall adopt delegated acts related to points (a) and (d) and implementing acts in points (b) and (c) to specify the following:

Or. en

Amendment 459

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) details of the application for the approval of hospital exemption referred to in paragraph 1, second subparagraph, including the evidence on quality, safety and efficacy of the advance therapy medicinal products prepared under hospital exemption for the approval and the subsequent changes;

deleted

Or. en

Amendment 460

Ondřej Knotek, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the data to be collected by Member States, including a description of the use of hospital exemption, the number of patients treated, the clinical and quality of life outcomes used to measure efficacy and safety of the advance therapy medicinal products prepared under the hospital exemption;

Or. en

Amendment 461

Susana Solís Pérez, Ondřej Knotek

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the data collection by Member States should cover the application of the hospital exemption, details of the patient group treated including patient counts, and the outcomes related to clinical efficacy and safety, as well as quality of life assessments.

Or. en

Amendment 462

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) the modalities for the exchange of knowledge between hospital exemption approval holders within the same Member State or different Member States;

deleted

Or. en

Amendment 463

István Ujhelyi

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) the modalities for the exchange of knowledge between hospital exemption approval holders within the same Member State or different Member States;

(c) the modalities for the exchange of knowledge between hospital exemption approval holders and holders of, or applicants for, marketing authorisations for advanced therapy medicinal products within the same Member State or different Member States;

Or. en

Amendment 464

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

deleted

Or. en

Amendment 465

Susana Solís Pérez, Catherine Amalric, Ondřej Knotek

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

(d) the modalities for harmonised implementation of the preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

Or. en

Amendment 466

Ondřej Knotek, Catherine Amalric, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

(d) the modalities for harmonised implementation of preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

Or. en

Amendment 467

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption on a non-routine basis.

(d) the modalities for preparation and use of advanced therapy medicinal products under hospital exemption;

Or. en

Amendment 468

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the modalities of guidance for academic and other not-for-profit entities through the requirements of the hospital exemption clause and the centralised marketing authorisation procedure.

Or. en

Amendment 469

Margrete Auken

Proposal for a directive

Article 2 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Those delegated acts shall be adopted pursuant to Article 215 and implementing acts shall be adopted in accordance with the examination procedure referred to in Article 214(2).

Or. en

Amendment 470

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 8

Text proposed by the Commission

Amendment

8. The Agency shall provide to the Commission a report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter.

These reports and the data contained therein shall be made publicly available and shall be considered in any subsequent legislative decision or amendment, following stakeholders' consultation.

Or. en

Amendment 471

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 8

Text proposed by the Commission

Amendment

The contents of these reports, which detail the data, will be accessible to the public and will be taken into account during future legislative deliberations or amendments, subsequent to consultations with involved parties.

Or. en

Amendment 472

Margarita de la Pisa Carrión

Proposal for a directive

Article 2 – paragraph 8

Text proposed by the Commission

Amendment

8. The Agency shall provide to the Commission a public access report on the experience acquired with the hospital exemption approvals on the basis of contributions from Member States and the data referred to in paragraph 4. The first report shall be provided three years after [OP please insert the date =18 months after the date of entering into force of this Directive] and then every five years thereafter.

Or. en

Amendment 473

István Ujhelyi

Proposal for a directive

Article 2 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. In order to inform patients, healthcare professionals and other stakeholders, the EMA shall make the hospital exemption approvals, the repository mentioned in paragraph 6 and the reports mentioned in paragraph 8 publicly available, after deletion of personal data and commercially confidential information.

Or. en

Amendment 474

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 2 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. Competent authorities shall guarantee that the authorization of products through the centralized procedure shall not adversely affect the activities and responsibilities of developers functioning under the hospital exemption as outlined in paragraphs 3 and 4.

Or. en

Amendment 475

István Ujhelyi

Proposal for a directive

Article 3 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Or. en

Amendment 476

Nathalie Colin-Oesterlé

Proposal for a directive

Article 3 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, including those prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility or developed in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Or. fr

Amendment 477

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 3 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility, or prepared in accordance with the specifications of a competent authority. However, in such case Member States shall encourage healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Or. en

Amendment 478

Margrete Auken

Proposal for a directive

Article 3 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

A Member State may, in order to fulfil special needs, exclude from the scope of this Directive medicinal products supplied in response to a bona fide unsolicited order, prepared in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility. However, in such case Member States shall establish channels for healthcare professionals and patients to report data on the safety of the use of such products to the competent authority of the Member State in accordance with Article 97.

Or. en

Amendment 479

Pernille Weiss

Proposal for a directive

Article 3 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

For allergen medicinal products supplied in accordance with this paragraph, the competent authorities of the Member State may request the submission of relevant information in accordance with Annex II.

deleted

Or. en

Justification

See AM to Annex I one of the revised pharmaceutical regulation.

Amendment 480

Margrete Auken

Proposal for a directive

Article 3 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

For allergen medicinal products supplied in accordance with this paragraph, the competent authorities of the Member State shall request the submission of relevant information in accordance with Annex II.

Or. en

Amendment 481

Margarita de la Pisa Carrión

Proposal for a directive

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2. Without prejudice to Article 30 of [revised Regulation (EC) No 726/2004], Member States may temporarily authorise the use and distribution of an unauthorised medicinal product in response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

2. Without prejudice to Article 30 of [revised Regulation (EC) No 726/2004], only Member States may temporarily authorise in the case of an official sanitary emergency, if doesn't exist other effective therapeutical alternative, the use and distribution of an unauthorised medicinal product in response to a confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

Or. en

Amendment 482

Margarita de la Pisa Carrión

Proposal for a directive

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that marketing authorisation holders, manufacturers and healthcare professionals are not subject to civil or administrative liability for any consequences resulting from the use of a medicinal product otherwise than for the authorised therapeutic indications or from the use of an unauthorised medicinal product, where such use is recommended or required by a competent authority in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not a national or a centralised marketing authorisation has been granted.

3. Member States will be responsible resulting from the use of a medicinal product otherwise than for the authorised therapeutic indications or from the use of an unauthorised medicinal product, where such use is recommended by a competent authority in response to the officially confirmed spread, as provided for in Article 3(2), of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm. Such provisions shall apply whether or not a national or a centralised marketing authorisation has been granted.

Or. en

Amendment 483

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 1 – introductory part

Text proposed by the Commission

Amendment

(1) ‘medicinal product’ means any substance or combination of substances that fulfils at least one of the following conditions:

(1) ‘medicinal product’ means any known substance or combination of substances that fulfils at least one of the following conditions:

Or. en

Amendment 484

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 1 – point a

Text proposed by the Commission

Amendment

(a) any substance or combination of substances that is presented as having properties for treating or preventing disease in human beings; or

(a) presents pharmacological activity that can be used for treating or preventing disease in human beings; or

Or. en

Amendment 485

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 1 – point b

Text proposed by the Commission

Amendment

(b) any substance or combination of substances that may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

(b) may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.

Or. en

Amendment 486

Pernille Weiss

Proposal for a directive

Article 4 – paragraph 1 – point 4 a (new)

Text proposed by the Commission

Amendment

(4 a) ‘plasma for fractionation’ means the liquid part of human blood separated from whole blood or collected by apheresis and intended to be used as the starting material for manufacture of plasma-derived medicinal products;

Or. en

Amendment 487

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 10 a (new)

Text proposed by the Commission

Amendment

(10 a) 'clock stop’ means a period of time during which the evaluation of a medicine is officially stopped, while the applicant prepares responses to questions from the regulatory authority. The clock resumes when the applicant has sent its responses.

Or. en

Amendment 488

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 11

Text proposed by the Commission

Amendment

(11) ‘non-clinical’ means a study or a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling, other non-human or human biology-based test methods, and animal-based tests;

(11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and simulation, other non-human or human biology-based test methods, aquatic egg models as well as invertebrate species and animal-based tests;

Or. en

Amendment 489

Stelios Kympouropoulos

Proposal for a directive

Article 4 – paragraph 1 – point 11

Text proposed by the Commission

Amendment

(11) ‘non-clinical’ means a study or a test conducted in vitro, ex vivo, in silico, or in chemico, or a non-human in vivo test related to the investigation of the safety and efficacy of a medicinal product. Such test may include simple and complex human cell-based assays, microphysiological systems including organ-on-chip, computer modelling and other in silico methods, other non-human or human biology-based test methods, and animal-based tests;

Or. en

Amendment 490

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 12

Text proposed by the Commission

Amendment

(12) ‘reference medicinal product’ means a medicinal product that is or has been authorised in the Union under Article 5, in accordance with Article 6;

(12) ‘reference medicinal product’ means a medicinal product that is or has been authorised in the Union under Article 5, in accordance with Article 6, that can be used for comparative purposes againts another medicinal product of similar characteristics;

Or. en

Amendment 491

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘generic medicinal product’ means a medicinal product that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product;

(13) ‘generic medicinal product’ means a medicinal product that has the same qualitative and quantitative composition in active substances,the same pharmaceutical form and pharmaceutical equivalence as the reference medicinal product;

Or. en

Amendment 492

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 15

Text proposed by the Commission

Amendment

(15) ‘letter of access’ means an original document, signed by the owner of the data or its representative, that states that the data may be used for the benefit of a third party by a competent authority or the Commission for the purposes of this Directive;

(15) ‘letter of access’ means an original document, signed by the owner of the data or their representative, that states that the data may be used for the benefit of a third party by a competent authority or the Commission for the purposes of this Directive;

Or. en

Amendment 493

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 16

Text proposed by the Commission

Amendment

(16) ‘fixed dose combination medicinal product’ means a medicinal product consisting of a combination of active substances intended to be placed on the market as a single pharmaceutical form;

(16) ‘fixed dose combination medicinal product’ means a medicinal product consisting of a combination of active substances, at a fixed dose, intended to be placed on the market as a single pharmaceutical form;

Or. en

Amendment 494

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 20

Text proposed by the Commission

Amendment

(20) ‘kit’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;

(20) ‘kit for radiopharmaceutical preparations’ means any preparation to be reconstituted or combined with radionuclides in the final radiopharmaceutical, usually prior to its administration;

Or. en

Amendment 495

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 22

Text proposed by the Commission

Amendment

(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals and antifungals;

Or. en

Amendment 496

Peter Liese

Proposal for a directive

Article 4 – paragraph 1 – point 22

Text proposed by the Commission

Amendment

Or. en

Justification

This approach aligns with the wording used in the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This consistency in regulatory language across different frameworks helps to maintain a uniform standard in managing the risk of antimicrobial resistance.

Amendment 497

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

Proposal for a directive

Article 4 – paragraph 1 – point 22

Text proposed by the Commission

Amendment

Or. en

Amendment 498

Joanna Kopcińska

Proposal for a directive

Article 4 – paragraph 1 – point 22

Text proposed by the Commission

Amendment

Or. en

Amendment 499

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 22

Text proposed by the Commission

Amendment

(22) ‘antimicrobial’ means any medicinal product with a direct action on micro-organisms (including viruses) used for treatment or prevention of infections or infectious diseases, including antibiotics, antivirals and antifungals;

Or. en

Amendment 500

Fulvio Martusciello

Proposal for a directive

Article 4 – paragraph 1 – point 26

Text proposed by the Commission

Amendment

(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulation (EU) 2017/745) and where the two are intended for use in the given combination in accordance with the summary of product characteristics;

(26) ‘combination of a medicinal product with a product other than a medical device’ means a combination of a medicinal product with a product other than a medical device (as defined by Regulation (EU) 2017/745) and Regulation (EU) 2017/746) and where the two are intended for use in the given combination in accordance with the summary of product characteristics;

Or. en

Amendment 501

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 28

Text proposed by the Commission

Amendment

(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response for prevention, including post exposure prophylaxis, and for treatment of diseases caused by an infectious agent;

(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response against an antigen or antigens for prevention, including post exposure prophylaxis, and for treatment of diseases caused by an infectious agent;

Or. en

Amendment 502

Margarita de la Pisa Carrión

Proposal for a directive

Article 4 – paragraph 1 – point 28

Text proposed by the Commission

Amendment

(28) 'vaccine’ means any medicinal product that is intended to elicit an immune response for prevention, including post exposure prophylaxis, and diseases caused by an infectious agent;

Or. en

Amendment 503

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 29 – introductory part

Text proposed by the Commission

Amendment

(29) ‘gene therapy medicinal product’ means a medicinal product, except vaccines against infectious diseases, that contains or consists of:

(29) ‘gene therapy medicinal product’ means a biological medicinal product, except vaccines against infectious diseases, that contains or consists of:

Or. en

Amendment 504

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 29 – point a

Text proposed by the Commission

Amendment

(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contains or consists of cells subjected to such genetic modifications; or

Or. en

Amendment 505

Peter Liese

Proposal for a directive

Article 4 – paragraph 1 – point 29 – point a

Text proposed by the Commission

Amendment

(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

(a) a substance or a combination of substances that edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

Or. en

Amendment 506

István Ujhelyi

Proposal for a directive

Article 4 – paragraph 1 – point 29 – point a

Text proposed by the Commission

Amendment

(a) a substance or a combination of substances intended to edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

(a) substance or a combination of substances edit the host genome in a sequence-specific manner or that contain or consists of cells subjected to such modification; or

Or. en

Amendment 507

István Ujhelyi

Proposal for a directive

Article 4 – paragraph 1 – point 29 – point b

Text proposed by the Commission

Amendment

(b) a recombinant or synthetic nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications;

deleted

Or. en

Amendment 508

Peter Liese

Proposal for a directive

Article 4 – paragraph 1 – point 29 – point b

Text proposed by the Commission

Amendment

(b) technologies that do not effect the DNA and/or the cell nucleus.

Or. en

Justification

From both a scientific and public health perspective, the term 'gene therapy medicinal product' should be strictly limited to products that edit or alter the human genome. Including products that do not modify the genome in this definition could lead to misconceptions, particularly concerning nucleic acid products, and contribute to confusion and fear in the field of gene therapy, wrongly suggesting that such treatments, like mRNA technologies, alter the human genome.

Amendment 509

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 29 – point b

Text proposed by the Commission

Amendment

(b) a recombinant nucleic acid used in or administered to human beings with a view to regulating, replacing or adding a genetic sequence that mediates its effect by transcription or translation of the transferred genetic materials or that contain or consists of cells subjected to these modifications;

Or. en

Amendment 510

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 30 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

(b) presents properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

Or. en

Amendment 511

Dolors Montserrat, Tomislav Sokol

Proposal for a directive

Article 4 – paragraph 1 – point 30 a (new)

Text proposed by the Commission

Amendment

(30 a) ‘platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles. The Commission should promote the development of Platform Technologies that should be part of an open platform, available for the different developers (academic, small biotech and big pharma) generating knowledge and data that once available can accelerate the process of development and evaluation of new therapies. In this context, the supported Platform Technology will appear in the status of PRE-COMPETITION and if it is having advantage of as an existing patent, it will be available under reasonable fee. These Platform Technologies once open to all the stakeholders can be easily updated while having regulatory support in benefit of EU patients.

Or. en

Amendment 512

István Ujhelyi

Proposal for a directive

Article 4 – paragraph 1 – point 30 a (new)

Text proposed by the Commission

Amendment

(30 a) 'platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles.

Or. en

Amendment 513

Billy Kelleher

Proposal for a directive

Article 4 – paragraph 1 – point 30 b (new)

Text proposed by the Commission

Amendment

(30 b) 'platform technology’ means a specific technology or a collection of technologies used in the manufacturing process and/or the quality control, the nonclinical or clinical testing of one or more medicinal products and/or components that rely on prior knowledge and are established under the same underlying scientific principles.

Or. en

Amendment 514

Billy Kelleher, Ondřej Knotek, Catherine Amalric

Proposal for a directive

Article 4 – paragraph 1 – point 30 a (new)

Text proposed by the Commission

Amendment

(30 a) platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established, and which is prepared in a separate document by the owner of the platform technology. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to

Or. en

Amendment 515

Dolors Montserrat, Tomislav Sokol

Proposal for a directive

Article 4 – paragraph 1 – point 30 b (new)

Text proposed by the Commission

Amendment

(30 b) ‘platform technology master file’ means a document that contains a detailed description of a platform technology for which the underlying scientific principles under which the platform technology is established. This can encompass quality, pre-clinical and/or clinical data in relation to the medicinal products and/or components the platform technology refers to.

Or. en

Amendment 516

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 31 – point a

Text proposed by the Commission

Amendment

(a) a method involving an industrial process which includes pooling of donations; or

(a) a method involving an industrial process which includes pooling of donations, for purposes beyond processing of SoHOs for concentrates or pathogen inactivation; or

Or. en

Amendment 517

Nathalie Colin-Oesterlé

Proposal for a directive

Article 4 – paragraph 1 – point 31 – point a

Text proposed by the Commission

Amendment

(a) a method involving an industrial process which includes pooling of donations; or

(a) a method involving an industrial process which includes pooling of donations with a view to a future fractionation; or

Or. fr

Amendment 518

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 31 – point a

Text proposed by the Commission

Amendment

(a) a method involving an industrial process which includes pooling of donations; or

(a) a method involving an industrial process which includes pooling of donations for subsequent fractionation; or

Or. en

Justification

In the preparation of blood components, there are many cases where pooling can take place, such as platelet concentrates, or for pathogen inactivation. To consider these as medicinal products would be incorrect and would bring severe disruption to the work of blood establishments in ensuring the safe and sufficient supply of blood components.

Amendment 519

Nathalie Colin-Oesterlé

Proposal for a directive

Article 4 – paragraph 1 – point 31 – point b

Text proposed by the Commission

Amendment

(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties;

(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties; where a process involves the pooling, concentration, separation or isolation of elements in the preparation of SoHOs, or any other method that increases the microbiological quality, it should not be considered a change in their inherent properties;

Or. fr

Amendment 520

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 31 – point b

Text proposed by the Commission

Amendment

(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties;

(b) a process that extracts an active ingredient from the substance of human origin or transforms the substance of human origin by changing its inherent properties; when a process concerns pooling, concentrating, separating or isolating elements in the preparation of SoHO, as well as methods that increase micro-biological quality, this should not be considered as changing their inherent properties;

Or. en

Justification

This refers to everyday processes in treating SoHO. Already partly in recital 16 but should be added here for the sake of clarity. “Pooling” and “methods that increase micro-biological quality” are added because these are not covered by the original proposal and are routine operations performed on SoHO which could be interpreted to change their inherent properties. If that were to happen, some SoHO would become medicinal products which would cause severe disruption to the work of blood establishments in ensuring the safe and sufficient supply of blood components in Europe.

Amendment 521

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 33

Text proposed by the Commission

Amendment

(33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

(33) ‘environmental risk assessment’ means the evaluation of the risks and potential risks to the environment, or risks to public health, posed by the release of the medicinal product in the environment from the use, manufacturing and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Or. en

Amendment 522

Catherine Amalric

Proposal for a directive

Article 4 – paragraph 1 – point 33

Text proposed by the Commission

Amendment

(33) ‘environmental risk assessment’ means the evaluation of the risks to the environment, including global warming, or risks to public health, posed by the manufacture, use and disposal of the medicine, as well as its release into the environment. The assessment includes the determination of measures to prevent, limit and mitigate these risks. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Or. en

Amendment 523

Fulvio Martusciello

Proposal for a directive

Article 4 – paragraph 1 – point 33

Text proposed by the Commission

Amendment

(33) ‘environmental risk assessment’ means the evaluation of the potential risks to the environment, posed by the release of the medicinal product in the environment from the use of the medicinal product and mitigation measures. For medicinal product with an antibiotic mode of action, the ERA also encompasses an evaluation of the risk for antibiotic resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Or. en

Amendment 524

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 33

Text proposed by the Commission

Amendment

(33) ‘environmental risk assessment’ means the evaluation of the potential and actual risks to the environment, or risks to public health, including antimicrobial resistance, posed by the release of the medicinal product in the environment from the manufacturing, use and disposal of the medicinal product and the identification of risk prevention, limitation and mitigation measures. For medicinal product with an antimicrobial mode of action, the ERA also encompasses an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Or. en

Amendment 525

Margarita de la Pisa Carrión

Proposal for a directive

Article 4 – paragraph 1 – point 33

Text proposed by the Commission

Amendment

(33) ‘environmental risk assessment’ means the evaluation of the potential to the environment, posed by the release of the medicinal product in the environment from the use of the medicinal product and mitigation measures. For medicinal product with an antibiotic mode of action, the ERA also encompasses an evaluation of the risk for antibiotic resistance selection in the environment due to the manufacturing, use and disposal of that medicinal product;

Or. en

Amendment 526

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 34

Text proposed by the Commission

Amendment

(34) ‘antimicrobial resistance’ means the ability of a micro-organism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually sufficient to inhibit or kill that micro-organism;

(34) ‘antimicrobial resistance’ means the ability of a microorganism to survive or to grow in the presence of a concentration of an antimicrobial agent that is usually or was in the past sufficient to inhibit or kill that microorganism;

Or. en

Amendment 527

Sirpa Pietikäinen

Proposal for a directive

Article 4 – paragraph 1 – point 35 – point b

Text proposed by the Commission

Amendment

(b) of undesirable effects on the environment posed by the medicinal product;

(b) of undesirable effects or risks on the environment posed by the medicinal product;

Or. en

Amendment 528

Fulvio Martusciello

Proposal for a directive

Article 4 – paragraph 1 – point 35 – point c

Text proposed by the Commission

Amendment

(c) of undesirable effects on public health due to the release of the medicinal product in the environment including anti-microbial resistance;

(c) of undesirable effects due to the release of the medicinal product in the environment including antibiotic resistance;

Or. en

Amendment 529

Massimiliano Salini, Francesca Peppucci

Proposal for a directive

Article 4 – paragraph 1 – point 36 a (new)

Text proposed by the Commission

Amendment

(36 a) 'Quality Master File' means a comprehensive document provided by the manufacturer of an active substance, excluding chemical active substances. This document includes a thorough description of the manufacturing process, quality control procedures throughout production, and the validation process. It is mandated by Annex II and is prepared as a distinct document, encompassing details about the active substance or any other substances utilized in the production of a medicinal product.

Or. en

Amendment 530

Margarita de la Pisa Carrión

Proposal for a directive

Article 4 – paragraph 1 – point 39

Text proposed by the Commission

Amendment

(39) ‘medicinal prescription’ means any medicinal prescription issued by a professional person qualified to do so;

(39) 'Prescription' means a prescription for a medicinal product issued by a member of a regulated health profession within the meaning of Article 3 (1) (a) of Directive 2005/36/EC who is legally entitled to do so in the Member State in which the prescription is issued

Or. en

Amendment 531

Margrete Auken

Proposal for a directive

Article 4 – paragraph 1 – point 41

Text proposed by the Commission

Amendment

(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35), subpoint (a);

(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35);

Or. en

Justification

Directive in line with the equivalent definition given in Regulation (EU) 2019/6 (Veterinary Medicinal Products Regulation), Article 4 (19) - including the impact on public health and the environment in the risk benefit balance

Amendment 532

Sirpa Pietikäinen

Proposal for a directive

Article 4 – paragraph 1 – point 41

Text proposed by the Commission

Amendment

(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35), subpoint (a);

(41) ‘benefit-risk balance’ means an evaluation of the positive therapeutic effects of the medicinal product in relation to the risks referred to in point (35);

Or. en

Amendment 533

Kateřina Konečná

Proposal for a directive

Article 4 – paragraph 1 – point 53 a (new)

Text proposed by the Commission

Amendment

(53 a) ‘patients’ organisations’ means not-for-profit organisations which are patient focused, and where patients and/or carers, when patients are unable to represent themselves, represent a majority of members in governing bodies;

Or. en

Justification

Patients’ organisations, led and integrated by patients and carers, are irreplaceable stakeholders in the development and authorisation of medicines, and only their involvement can ensure that patients' views are legitimately represented. Therefore, the centrality of patient involvement in decisions around treatment should be integrated into the EU medicines legislation through a clear definition of ‘patients’ organisation’, based on the widely used European Medicines Agency definition.

Amendment 534

Sirpa Pietikäinen

Proposal for a directive

Article 4 – paragraph 1 – point 58

Text proposed by the Commission

Amendment

(58) ‘risk management system’ means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions;

(58) ‘risk management system’ means a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise public health or environment risks relating to a medicinal product, including the assessment of the effectiveness of those activities and interventions;

Or. en

Amendment 535

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 59

Text proposed by the Commission

Amendment

(59) ‘adverse reaction’ means a response to a medicinal product that is noxious and unintended;

(59) ‘adverse reaction’ means an effect on a person in response to a received medicinal product that is noxious and unintended;

Or. en

Amendment 536

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 60

Text proposed by the Commission

Amendment

(60) ‘serious adverse reaction’ means an adverse reaction that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or a birth defect;

Or. en

Amendment 537

Margarita de la Pisa Carrión

Proposal for a directive

Article 4 – paragraph 1 – point 61 b (new)

Text proposed by the Commission

Amendment

(61 b) 'adverse event' means any health problem that occurs after administration without necessarily being caused by the administration of a medication. Later it will be determined if they are coincident or related.

Or. en

Amendment 538

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 62

Text proposed by the Commission

Amendment

(62) ‘homeopathic medicinal product’ means a medicinal product prepared from homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States;

deleted

Or. en

Amendment 539

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 64

Text proposed by the Commission

Amendment

(64) ‘herbal medicinal product’ means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more herbal preparations;

(64) ‘herbal medicinal product’ means any medicinal product, exclusively containing as source of active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more herbal preparations;

Or. en

Amendment 540

Marian-Jean Marinescu

Proposal for a directive

Article 4 – paragraph 1 – point 70

Text proposed by the Commission

Amendment

(70) ‘public service obligation’ means to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.

(70) ‘public service obligation’ means to guarantee permanently an adequate range and the necessary quantity of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.

Or. en

Justification

Clarification necessary to prevent shortages of medicines

Amendment 541

Peter Liese

Proposal for a directive

Article 4 – paragraph 1 – point 70

Text proposed by the Commission

Amendment

(70) ‘public service obligation’ means to ensure permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time over the whole of the area in question.

Or. en

Amendment 542

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 70

Text proposed by the Commission

Amendment

Or. en

Amendment 543

Margarita de la Pisa Carrión

Proposal for a directive

Article 4 – paragraph 1 – point 70 a (new)

Text proposed by the Commission

Amendment

(70 a) ‘decentralised site’ means a site where manufacturing or testing steps of medicinal products take place in compliance with the principles of good manufacturing practice under the responsibility of the qualified person of a central site holding a manufacturing authorisation.”

Or. en

Justification

Sites performing purely non-manufacturing activities, such as SoHO donor review and eligibility assessment, donor testing, cell collection and preservation, should not fall under the obligation to register as decentralized sites. Such sites have site master files available and are registered locally under the national competent authorities. An obligation to register sites performing purely non- manufacturing activities as part of the ManufacturingAuthorization Application in parallel goes against the spirit of thelegislation and would lead to a disproportionate and duplicativeadministrative burden

Amendment 544

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 1 – point 70 a (new)

Text proposed by the Commission

Amendment

(70 a) "decentralised manufacturing" means a production model where manufacturing of medicinal products needs to take place in local sites close to patients.

Or. en

Amendment 545

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in accordance with Article 215 to amend the definitions in paragraph 1, points (2) to (6), (8), (14), (16) to (31), in the light of technical and scientific progress and taking into account definitions agreed at Union and international level without extending the scope of the definitions.

deleted

Or. en

Amendment 546

Joanna Kopcińska

Proposal for a directive

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Definitions should not be ameneded through delegated acts as essential part of legislation

Amendment 547

Margrete Auken

Proposal for a directive

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 548

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.

2. When an initial marketing authorisation has been granted in accordance with paragraph 1, any development concerning the medicinal product covered by the authorisation such as additional therapeutic indication, strengths, pharmaceutical forms, administration routes, presentations, as well as any variations of the marketing authorisation shall also be granted an authorisation in accordance with paragraph 1 or be included in the initial marketing authorisation. All those marketing authorisations as well as those obtained by this marketing authorisation holder according to Articles 9 to 12 shall be considered as belonging to the same global marketing authorisation, in particular for the purpose of the marketing authorisations applications under Articles 9 to 12, including as regards the expiry of the regulatory data protection period for applications using a reference medicinal product.

Or. en

Amendment 549

Joanna Kopcińska

Proposal for a directive

Article 5 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Developments lacking therapuetic contributions shall always be granted in accodrance with paragraph 1 and be considered as belonging to the same global marketing authorisation.

Or. en

Amendment 550

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher

Proposal for a directive

Article 6 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The marketing authorisation application shall include the results of controlled clinical trials randomised versus an established medicinal product of proven therapeutic value with clinical endpoints or versus placebo in case of lack of established medicinal product of proven therapeutic value. Any other design shall be duly justified and accepted only for exceptional situations.

Or. en

Amendment 551

Billy Kelleher, Ondřej Knotek, Catherine Amalric

Proposal for a directive

Article 6 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The marketing authorisation application shall include the particulars and documentation listed in Annex I, submitted in accordance with Annex II. Where justified for therapeutic purposes, a marketing authorisation may be granted for a medicinal product for which an active substance master file, an additional quality master file and/or a platform technology master file exists and is referred to in the application.

Or. en

Amendment 552

Margrete Auken

Proposal for a directive

Article 6 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Applications for market authorisation shall provide evidence from comparative studies with a standard-of-care active comparator, including, but not limited to, randomised controlled trials. In exceptional circumstances, where such studies cannot be provided for scientifically substantiated reasons, the applicant shall submit such duly justified reasoning to the national competent authority as part of the application for marketing authorisation. The Agency shall set the scientific guidelines on criteria for proposing a comparator for a clinical trial, taking into account the results of the consultation of the Commission and the authorities or bodies involved in the mechanism of consultation referred to in Article 162 of [revised Regulation (EC) No 726/2004].

Or. en

Justification

Comparative data should be the standard rather than the bonus already when it comes to authorisation of medicines. It would make it easier to then conduct HTA assessment and pricing and reimbursement decisions where this data is typically required. Requiring comparative data would result in more robust evidence at the time of marketing authorisation and it would reduce duplication of clinical studies.

Amendment 553

Margrete Auken

Proposal for a directive

Article 6 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. Applications for marketing authorisation shall include patient experience data (PROMs/PREMs) in the marketing application dossier. Where such data cannot be provided, the applicant should provide a justification to the Agency.

Or. en

Justification

In order to ensure medicines serve the need of patients, measuring patient experiences in clinical studies and reporting on them to regulators is crucial

Amendment 554

Sirpa Pietikäinen

Proposal for a directive

Article 6 – paragraph 4

Text proposed by the Commission

Amendment

4. The risk management system referred to in Annex I shall be proportionate to the identified risks and the potential risks of the medicinal product, and the need for post-authorisation safety data.

4. The risk management system referred to in Annex I shall be proportionate to the identified risks and the potential public health or environment risks of the medicinal product, and the need for post-authorisation safety data.

Or. en

Amendment 555

Heléne Fritzon

Proposal for a directive

Article 6 – paragraph 5 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan;

(a) the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan. In the absence of randomised controlled studies involving an active comparator group, scientific substantiation is required as to why the studies referred to could not be carried out.

Or. sv

Justification

It is crucial to step up requirements for conducting randomised clinical trials with active comparator groups, this being the gold standard for evidence generation. Active comparator treatment should be a treatment that is clinically meaningful in at least two EU Member States and for a population of at least 50 million citizens. Such comparisons require the PICO process described in the EU HTA Regulation.

Amendment 556

Sunčana Glavak

Proposal for a directive

Article 6 – paragraph 5 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) when the agreed paediatric investigation plan cannot be timely accomplished due to failure to conduct paediatric clinical studies, the evidence obtained from extrapolation and all information on safety and efficacy collected from the appropriately designed post-marketing long-term studies

Or. en

Amendment 557

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 6 – paragraph 5 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) in the absence of comparative studies, a justification to substantiate the reasons why the above mentioned studies could not be conducted;

Or. en

Amendment 558

Marian-Jean Marinescu

Proposal for a directive

Article 6 – paragraph 7 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall demonstrate that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted in support of the application. Where appropriate the marketing authorisation applicant shall not carry out animal testing to meet the requirements of this legislation where non-animal methods that are acceptable to the competent authorities, are available.’

Or. en

Justification

Methodology that is scientifically satisfactory may not necessarily be acceptable to regulatory authorities. A caveat is allowed for as such methodology must be acceptable to non-EU regulatory authorities internationally otherwise animal tests will still require to be undertaken.

Amendment 559

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 6 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available.

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available. The marketing authorisation applicant shall not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing shall ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been applied in compliance with Directive 2010/63/EU with regard to any animal study conducted for the purpose of supporting the application.

Or. en

Amendment 560

Stanislav Polčák

Proposal for a directive

Article 6 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available.

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available, or where the results of animal studies previously carried out by the applicant or others may be used for the medicinal product.

Or. cs

Amendment 561

Margrete Auken

Proposal for a directive

Article 6 – paragraph 7 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory non-animal testing methods are available.

The marketing authorisation applicant shall not carry out animal testing in case scientifically satisfactory New Approach Methodologies (NAMs), particularly non-animal testing methods are available.

Or. en

Amendment 562

Margarita de la Pisa Carrión

Proposal for a directive

Article 6 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. A marketing authorisation may be granted for a medicinal product on the basis of an active substance master file, an additional quality master file or a platform technology master file.

Or. en

Amendment 563

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 9 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted. In this case, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.

Paragraph 1 shall also apply if the reference medicinal product has not been authorised in the Member State in which the application for the generic medicinal product is submitted, unless the applicant of the generic product is also the marketing authorisation holder or a related company of the reference medicinal product. In the latter case the complete dossier should be submitted. In the former case, the applicant shall indicate in the application the name of the Member State in which the reference medicinal product is or has been authorised. At the request of the competent authority of the Member State in which the application is submitted, the competent authority of the other Member State shall transmit within a period of one month a confirmation that the reference medicinal product is or has been authorised together with the full composition of the reference medicinal product and if necessary, any other relevant documentation.

Or. en

Amendment 564

Margrete Auken

Proposal for a directive

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product.

Or. en

Amendment 565

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

In cases where the medicinal product does not fall within the definition of a generic medicinal product or has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference medicinal product, the results of the appropriate non-clinical tests and clinical studies shall be provided to to the extent necessary to demonstrate essential similarity to the marketing authorisation for the reference medicinal product, and to demonstrate the safety and efficacy profile of the hybrid medicinal product in any additional indication.

Or. en

Amendment 566

Margarita de la Pisa Carrión

Proposal for a directive

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

For a biological medicinal product that is similar to a reference biological medicinal product (‘biosimilar medicinal product’), the results of appropriate comparability tests and studies shall be provided to the competent authorities. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex II and the related detailed guidelines. The results of other tests and studies from the reference medicinal product's dossier shall not be provided.

For a medicinal product that is similar to a reference biological medicinal product (‘biosimilar medicinal product’), the results of appropriate comparability tests and studies shall be provided to the competent authorities. The type and quantity of supplementary data to be provided must comply with the relevant criteria stated in Annex II and the related detailed guidelines. The results of other tests and studies from the reference medicinal product's dossier shall not be provided.

Or. en

Amendment 567

Margarita de la Pisa Carrión

Proposal for a directive

Article 11 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Where a medicinal product is not a biological medicinal product but it is similar to a reference biological medicinal product (‘synthetic follow-on medicinal product’), paragraph 1 shall apply and the synthetic follow-on medicinal product shall be subject to the requirements of this Directive and [revised Regulation 726/2004] applicable to biosimilar medicinal products.

Or. en

Justification

As for all types of medicinal products, all follow-ons to biologic medicines should be regulated based on sound scientific principles and established regulatory standards of safety, efficacy, and quality. Currently there is regulatory uncertainty about how synthetic follow-ons to biologic medicines are approved. All follow-ons to biological medicines should be appropriately assessed following an enhanced Article 11 of the proposed Directive. Appropriate non-clinical and clinical tests are added in art 11, considering the proposed deletion of Art. 12. Relating to the fact that synthetic follow-ons are not per se biosimilars – the proposed new paragraph is introduced. Further explanation on the role of biosimilar medicinal product and synthetic follow-on medicinal product: Scientifically, differences in manufacturing processes may significantly alter the properties of synthetic polypeptide products and could result in adverse clinical consequences. A synthetic follow-on product will likely differ from the biological reference product with regard to impurity profile and could differ with regard to stability, for example a different tendency towards fibrillation. This may lead to increased immunogenicity. It is important that these factors as well as the overall complexity of the product are considered in the development and subsequent regulatory evaluation. Available analytical methods may be insufficient to establish therapeutic equivalence of a synthetic follow-on product to a biological reference product; this applies in particular to non-clinical models to predict immunogenicity.

Amendment 568

Margarita de la Pisa Carrión

Proposal for a directive

Article 12

Text proposed by the Commission

Amendment

Article 12

deleted

Applications concerning bio-hybrid medicinal products

In cases where a biosimilar medicinal product has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference biological medicinal product (‘bio-hybrid’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety or efficacy profile of the biosimilar medicinal product.

Or. en

Amendment 569

Margrete Auken

Proposal for a directive

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

In cases where a biosimilar medicinal product has changes in strength, pharmaceutical form, route of administration or therapeutic indications, compared to the reference biological medicinal product (‘bio-hybrid’), the results of the appropriate non-clinical tests or clinical studies shall be provided to the competent authorities to the extent necessary to establish a scientific bridge to the data relied upon in the marketing authorisation for the reference biological medicinal product, and to demonstrate the safety and efficacy profile of the biosimilar medicinal product. The Agency shall adopt guidelines on the appropriate tests and clinical studies for marketing authorisation of bio-hybrid medicinal products.

Or. en

Amendment 570

Peter Liese

Proposal for a directive

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non-clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.

The applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non-clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.

Or. en

Justification

Compared to the current rules for well-established use, the Commission’s proposal only allows an application based on bibliographic data if there is no reference product available within the EU. This limits the prior scope of application significantly.

Amendment 571

Joanna Kopcińska

Proposal for a directive

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

In cases where no reference medicinal product is or has been authorised for the active substance of the medicinal product concerned, or there was a reference medicinal product but it is not currently available, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non-clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature.

Or. en

Justification

It is proposed that this procedure may also apply to the products / substances where there was reference medicinal products but is currently not marketed / available (for appropriate bioquivalence tests) and the applicant can prove that fact

Amendment 572

Margrete Auken

Proposal for a directive

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 573

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

In cases where no reference medicinal product is authorised for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(2), not be required to provide the results of non-clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II. In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature and demonstration that this literature is relevant for the applied product.

Or. en

Amendment 574

Billy Kelleher, Ondřej Knotek

Proposal for a directive

Article 15 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

Where justified for therapeutic purposes, a marketing authorisation may, in exceptional circumstances, be granted for a medicinal product comprised of a fixed component and a variable component that is pre-defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients (‘platform technology’).

Where justified for therapeutic purposes, a marketing authorisation may be granted for a medicinal product comprised of a fixed component and a variable component that is pre-defined in order to, where appropriate, target different variants of an infectious agent or, where necessary, to tailor the medicinal product to characteristics of an individual patient or a group of patients.

Or. en

Amendment 575

Joanna Kopcińska

Proposal for a directive

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Where justified for public health reasons and when the active substances cannot be combined within a fixed dose combination medicinal product, a marketing authorisation may, in exceptional circumstances, be granted to a multi-medicinal product package.

Or. en

Justification

The basic requirements for such registration should be clarified (e.g. requirements for product information in - SmPC, leaflet and packaging labeling) – without leaving this issue to be decided by the Member States.

Amendment 576

István Ujhelyi

Proposal for a directive

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Where a fixed dose combination medicinal product consists solely of active substances that meet the criteria for well-established medical use as defined in Article 13 [Applications based on bibliographic data], such a medicinal product shall also be considered to meet those criteria.

The application for marketing authorisation for a medicinal product as referred to in Article 15 (4) (a) shall fulfil the information requirements set out in Annex II, Part II, Section 1 [Well- established medicinal use]

Or. en

Amendment 577

Joanna Kopcińska

Proposal for a directive

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by amending Annexes IV to VI by specyfying additional requirements for multi-medicinal product package.

Or. en

Amendment 578

Margarita de la Pisa Carrión

Proposal for a directive

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. A marketing authorisation shall be required for radionuclide generators, kits, and radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1).

1. A marketing authorisation shall be required for radiopharmaceuticals generators, kits, and precursors radiopharmaceuticals.

Or. en

Amendment 579

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. A marketing authorisation shall be required for radionuclide generators, kits for radiopharmaceutical preparations, and radionuclide precursors, unless they are used as starting material, active substance or intermediate of radiopharmaceuticals covered by a marketing authorisation under Article 5(1).

Or. en

Amendment 580

Margarita de la Pisa Carrión

Proposal for a directive

Article 16 – paragraph 2

Text proposed by the Commission

Amendment

2. A marketing authorisation shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorised, according to national legislation, to use such radiopharmaceutical in an approved healthcare establishment exclusively from authorised radionuclide generators, kits or radionuclide precursors in accordance with the manufacturer's instructions.

2. A marketing authorisation shall not be required for radionuclides or radionuclide generators solely used for radiolabelling purposes, or for a radiopharmaceutical prepared at the time of use by an authorised person or establishment using an authorised kit for radiopharmaceutical preparation in combination with a radionuclide or radionuclide generator in accordance with the summary of product characteristics of the kit ('kit-radiolabelling').

Or. en

Amendment 581

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 16 – paragraph 2

Text proposed by the Commission

Amendment

2. A marketing authorisation shall not be required for a radiopharmaceutical prepared at the time of use by a person or by an establishment authorised, according to national legislation, to use such radiopharmaceutical in an approved healthcare establishment exclusively from authorised radionuclide generators, kits for radiopharmaceutical preparations or radionuclide precursors in accordance with the manufacturer's instructions.

Or. en

Amendment 582

Margrete Auken

Proposal for a directive

Article 17 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) an antimicrobial stewardship plan as referred to in Annex I;

(a) an antimicrobial stewardship and access plan as referred to in Annex I;

Or. en

Justification

Based on the US CAR-BX AMR mechanism - supported by NIH, Welcome Trust etc. developers early on are asked to think about both stewardship and access https://carb-x.org/about/stewardship-and-access/

Amendment 583

Maria Angela Danzì

Proposal for a directive

Article 17 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) an antimicrobial stewardship plan as referred to in Annex I;

(a) an antimicrobial resistance mitigation plan as referred to in Annex I;

Or. en

Justification

Activities to be taken solely by the pharmaceutical company should not be called antimicrobial stewardship, as this term is reserved for a broader and systemic actions to be taken by health systems and healthcare professionals.

Amendment 584

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I.

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior review and approval by the competent authority.

Or. en

Amendment 585

Kateřina Konečná

Proposal for a directive

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I.

(b) a description of the special information requirements outlined in Article 69 and listed in Annex I, for prior vetting by the competent authority.

Or. en

Justification

The Directive should state explicitly that the competent authorities should review, comment on, and approve the content of the educational materials developed by pharmaceutical companies for healthcare professionals on the use of the antimicrobial, so as to avoid any promotional or misleading information.

Amendment 586

Margrete Auken

Proposal for a directive

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. After granting marketing authorisation, the competent authority shall make publicly available the documents referred to in paragraph 1.

Or. en

Amendment 587

Margrete Auken

Proposal for a directive

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

2. The competent authority shall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship and access plan unsatisfactory.

Or. en

Amendment 588

Kateřina Konečná

Proposal for a directive

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

2. The competent authority shall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

Or. en

Amendment 589

Alessandra Moretti

Proposal for a directive

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

2. The competent authority shall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

Or. en

Amendment 590

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

2. The competent authority shall impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

Or. en

Amendment 591

Maria Angela Danzì

Proposal for a directive

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial stewardship plan unsatisfactory.

2. The competent authority may impose obligations on the marketing authorisation holder if it finds the risk mitigation measures contained in the antimicrobial resistance mitigation plan unsatisfactory.

Or. en

Justification

Amendment 592

Heléne Fritzon

Proposal for a directive

Article 17 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

deleted

Or. en

Justification

The commitment to therapy-appropriate package sizes should not be limited to antimicrobial agents but should apply to all medicinal products. Ensuring appropriate package sizes for all medicinal products is first and foremost a measure to avoid pharmaceutical and packaging waste and serves the environment. Currently available package sizes often prove to be too large and inadequate respectively as early-onset patient-individual side effects can cause therapy termination or switches as well as a necessity for dose reductions.

Amendment 593

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

Proposal for a directive

Article 17 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities corresponding to the duration of treatment. If an antimicrobial can not be dispensed per unit, the marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

Or. en

Amendment 594

Maria Angela Danzì

Proposal for a directive

Article 17 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

3. The marketing authorisation holder shall ensure, wherever possible, that the antimicrobial may be dispensed per unit in a number corresponding to the quantities described on the prescription. If an antimicrobial can not be dispensed per unit, the marketing authorization holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

Or. en

Justification

As the actual size of packaging of antimicrobials is difficult to adjust to all clinical guidelines, which may also change over time, the best way to dispense the needed quantity and to avoid stocking and waste is to dispense the exact number of units needed. The proposed provision on adjusting the package size to the usual posology and duration of the treatment is a step in the right direction, however per unit dispensing is more ambitious measure to limit the spread of AMR.

Amendment 595

Margrete Auken

Proposal for a directive

Article 17 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holder shall ensure that the pack size of the antimicrobial corresponds to the usual posology and duration of treatment.

3. The marketing authorisation holder shall ensure that the antimicrobial may be dispensed per unit in a number corresponding to the quantities prescribed by the treating physician.

Or. en

Justification

Per unit dispensing of antimicrobials has been listed as a core component of prudent use of antimicrobials in the EU guidelines and an effective tool to mitigate AMR. As the actual size of packaging of antimicrobials is difficult to adjust to all clinical guidelines, which may also change over time, the best way to dispense the needed quantity and to avoid stocking and waste is to dispense the exact number of units needed.

Amendment 596

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

Proposal for a directive

Article 17 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Pharmacists should play a role in antimicrobial stewardship, including advising on the prudent use of antibiotics and other antimicrobials, as well as their correct disposal.

Or. en

Amendment 597

Margrete Auken

Proposal for a directive

Article 17 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. By derogation from paragraph 3, in duly justified cases, national authorities may allow for pack sizes of the antimicrobial to correspond with the usual posology and duration of treatment.

Or. en

Amendment 598

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 18 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device.

Or. en

Amendment 599

Kateřina Konečná

Proposal for a directive

Article 18 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 600

Margarita de la Pisa Carrión

Proposal for a directive

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. The application for a marketing authorisation for an integral combination of a medicinal product with a medical device shall include the documentation supporting the compliance of the medical device part with the general safety and performance requirements as referred to in paragraph 2 in accordance with Annex II, including, where relevant, the conformity assessment report by a notified body.

3. The application for a marketing authorisation for an integral combination of a medicinal product with a medical device shall include the evidence supporting the compliance of the medical device part with the general safety and performance requirements as referred to in paragraph 2 in accordance with Annex II, including, where relevant, the assessment report by a notified body.

Or. en

Amendment 601

Margrete Auken

Proposal for a directive

Article 18 – paragraph 4

Text proposed by the Commission

Amendment

4. In its evaluation of the integral combination of a medicinal product with a medical device concerned, the competent authorities shall recognise the results of the assessment of compliance of the medical device part of that integral combination with the general safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/745 including, where relevant, the results of the assessment by a notified body.

Or. en

Amendment 602

Kateřina Konečná

Proposal for a directive

Article 19 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

As part of the assessment, in accordance with Article 29, of the medicinal product referred to in the first subparagraph, the competent authorities shall assess the benefit-risk balance of the medicinal product taking into account the use of the medicinal product together with the medical device.

Or. en

Amendment 603

Margarita de la Pisa Carrión

Proposal for a directive

Article 19 – paragraph 4

Text proposed by the Commission

Amendment

4. In its evaluation of the medicinal product referred to in paragraph 1 the competent authority shall recognise the results of the assessment of compliance of the medical device concerned with the general safety and performance requirements in accordance with Annex I of Regulation (EU) 2017/745 including, where relevant, the results of the assessment by a notified body.

Or. en

Amendment 604

Joanna Kopcińska

Proposal for a directive

Article 20 – title

Text proposed by the Commission

Amendment

Combinations of medicinal products with products other than medical devices

Or. en

Justification

Should such combination of products be registered as a medicinal product? it is necessary to determine what requirements a product of another category (e.g. diet supplement) must meet in order for it to be registered with a medicinal product as part of therapy and how to assess the benefit-risk ratio when dealing with products whose marketing authorization and subsequent supervision are subject of the assessment by National Competent Authority. The provisions of the proposed directive should indicate what requirements should be applied to the product information docs.

Amendment 605

Joanna Kopcińska

Proposal for a directive

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission is empowered to adopt delegated acts in accordance with Article 215 to supplement this Directive by specifying the following: a) specific categories of products other than medical devices that may be used in combination with medicinal products; b) specific requirements of suitability for the abovementioned categories of products other than medical devices; c) amending Annexes IV to VI by specyfying additional requirements for combinations of medicinal products with products other than medical devices.

Or. en

Amendment 606

Margrete Auken

Proposal for a directive

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

The applicant of a marketing authorisation for a medicinal product referred to in Articles 9 and 11 shall not be required to submit a risk management plan and a summary thereof, provided that no additional risk minimisation measures exist for the reference medicinal product and provided that the marketing authorisation for the reference medicinal product has not been withdrawn prior to the submission of the application.

Or. en

Amendment 607

Catherine Amalric

Proposal for a directive

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, and guidelines relating to the assessment of the greenhouse gas emissions footprint of a medicine, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Or. en

Amendment 608

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 6, or provide the duly justified reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Or. en

Amendment 609

Margrete Auken

Proposal for a directive

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 5, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Or. en

Amendment 610

Margarita de la Pisa Carrión

Proposal for a directive

Article 22 – paragraph 1

Text proposed by the Commission

Amendment

1. When preparing the environmental risk assessment (‘ERA’) to be submitted pursuant to Article 6(2), the applicant shall take into account the scientific guidelines on the environmental risk assessment of medicinal products for human use as referred to in paragraph 5, or provide the reasons for any divergence from the scientific guidelines to the Agency or, as appropriate to the competent authority of the Member State concerned, in a timely manner. Where available, the applicant shall take into account existing ERAs performed under other Union legislation.

Or. en

Amendment 611

Margrete Auken

Proposal for a directive

Article 22 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The ERA shall evaluate possible risks to the environment due to use and disposal of the medicinal product according to the requirements referred to in Annex II. With regard to risks resulting from manufacturing, the ERA shall provide information on discharges and emissions of the active substance and other environmentally relevant substances according to the requirements referred to in Annex II.

Or. en

Amendment 612

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. The ERA shall indicate whether the medicinal product or any of its ingredients or other constituents is one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:

2. The ERA shall evaluate the possible risks to the environment due to the use and disposal of the medicinal product according to the requirements referred to in Annex II . It shall indicate whether the medicinal product or any of its ingredients or other constituents is one of the following substances according to the criteria of Annex I to the Regulation (EC) No 1272/2008:

Or. en

Amendment 613

Margarita de la Pisa Carrión

Proposal for a directive

Article 22 – paragraph 2 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 614

Margarita de la Pisa Carrión

Proposal for a directive

Article 22 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

(c a) very persistent and very mobile (vPvM);

Or. en

Amendment 615

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

or are endocrine active agents.

(d) are endocrine active agents.

Or. en

Amendment 616

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. With regards to risks resulting from manufacturing, the ERA shall provide information on discharged and emissions of the active susbtance(s) and other environmentally relevant susbtances according to the requirements referred to in Annex II.

Or. en

Amendment 617

Margrete Auken

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, to reduce discharges and emissions of the medicinal product to the environment and information on available techniques that will be used to reduce those discharges and emissions, in particular those occurring in manufacturing effluents before these effluents leave the manufacturing sites and to limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Or. en

Amendment 618

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

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment. When necessary, it shall also include information on available techniques and on the techniques that will be used to reduce the discharges and emissions of the medicinal product, in particular those occuring in manufacturing effluents before these effluents leave the manufacturing sites.

Or. en

Amendment 619

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall also include in the ERA risk minimisation and mitigation measures to avoid or where it is not possible, limit:

Or. en

Amendment 620

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU or in the cases where risks to the environment are identified in the scientific guidelines drawn up by the Agency on the ERA requirements for medicinal products for human use as referred to in paragraph 5. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Or. en

Amendment 621

Stanislav Polčák

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. It will also focus on the risks associated with the inappropriate handling of a medicinal product that has become waste and include measures to minimise these risks. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Or. cs

Amendment 622

Catherine Amalric

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 623

Fulvio Martusciello

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. When the ERA indicates a risk to the environment, the applicant shall also include in the ERA risk mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Or. en

Amendment 624

Margarita de la Pisa Carrión

Proposal for a directive

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall also include in the ERA risk for the environment mitigation measures to avoid or where it is not possible, limit emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU. The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment.

Or. en

Amendment 625

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 3 – point a (new)

Text proposed by the Commission

Amendment

(a) emissions to air, water and soil of pollutants listed in Directive 2000/60/EC, Directive 2006/118/EC, Directive 2008/105/EC and Directive 2010/75/EU;

Or. en

Amendment 626

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 3 – point b (new)

Text proposed by the Commission

Amendment

(b) energy use, waste generation, non recycling materials;

Or. en

Amendment 627

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 3 – point c (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 628

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 3 – point d (new)

Text proposed by the Commission

Amendment

(d) any other hazard to the environment, animal and human health.

Or. en

Amendment 629

Sara Cerdas

Proposal for a directive

Article 22 – paragraph 3 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The applicant shall provide detailed explanation that the proposed mitigation measures are appropriate and sufficient to address the identified risks to the environment, as well as any circular economy processes adopted.

Or. en

Amendment 630

Catherine Amalric

Proposal for a directive

Article 22 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The applicant also includes in the ERA an assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product. It specifies risk mitigation measures aimed at limiting greenhouse gas emissions during the production and use of the medicine. The applicant explains in detail that the proposed mitigation measures are appropriate and sufficient to limit these emissions in line with the European Union's climate objectives of Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework required to achieve climate neutrality.

Or. en

Amendment 631

Margrete Auken

Proposal for a directive

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

4. For antimicrobials and other substances which may cause antimicrobial resistance, including products with an antimicrobial mode of action, the ERA shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including by healthcare professionals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Or. en

Amendment 632

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

Proposal for a directive

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the entire manufacturing supply chain inside and outside the Union, use and disposal, including also by the healthcare professionnals and patients, of the antimicrobial taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Or. en

Amendment 633

Margarita de la Pisa Carrión

Proposal for a directive

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

4. The ERA for antimicrobials shall include an evaluation of the risk for antimicrobial resistance selection in the environment due to the manufacturing, use and disposal of the antibiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Or. en

Amendment 634

Fulvio Martusciello

Proposal for a directive

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

4. The ERA for antibiotics shall include an evaluation of the risk for antibiotic resistance selection in the environment due to the manufacturing of the active substance or medicinal product within the European Union , use and disposal of the antibiotic taking into account, where relevant, the existing international standards that have established predicted no effect concentration (PNECs) specific for antibiotics.

Or. en

Amendment 635

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) on the drafting of these scientific guidelines.

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use including environmental risk mitigation measures thereof. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) the European Centre of Disease Control (ECDC) and other relevant stakeholders, including those managing residues from medicinal products and wastewater treatment on the drafting of these scientific guidelines.

Or. en

Amendment 636

Margrete Auken

Proposal for a directive

Article 22 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) on the drafting of these scientific guidelines.

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. The Agency shall consult the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) and other stakeholders, including drinking water and wastewater operators, on the drafting of these scientific guidelines.

Or. en

Amendment 637

Sirpa Pietikäinen

Proposal for a directive

Article 22 – paragraph 5

Text proposed by the Commission

Amendment

5. The Agency shall draw up scientific guidelines in accordance with Article 138 of [revised Regulation No (EC) 726/2004], to specify technical details regarding the ERA requirements for medicinal products for human use. Where appropriate, the Agency shall consult the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA) on the drafting of these scientific guidelines.

Or. en

Amendment 638

Margrete Auken

Proposal for a directive

Article 22 – paragraph 6 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

The marketing authorisation holder shall include analytical techniques and explanations in the methodology on the ERA and update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA. The update shall include updates on the emissions of the medicinal product in manufacturing effluents and any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Or. en

Amendment 639

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 6 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and could lead to a change of the conclusions of the ERA, including updates on the emissions of the medicinal product in manufacturing effluents. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, the collation of sales data and environmental exposure data.

Or. en

Amendment 640

Fulvio Martusciello

Proposal for a directive

Article 22 – paragraph 6 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder shall update the ERA with new information without undue delay to the relevant competent authorities, in accordance with Article 90(2), if new information pertaining to the assessment criteria referred to in Article 29 becomes available and leads to a change of the conclusions of the ERA. The update shall include any relevant information from environmental monitoring, including monitoring under Directive 2000/60/EC, from eco-toxicity studies, from new or updated risk assessments under other Union legislation, as referred to in paragraph 1, and environmental exposure data.

Or. en

Amendment 641

Sirpa Pietikäinen

Proposal for a directive

Article 22 – paragraph 6 – subparagraph 2

Text proposed by the Commission

Amendment

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment.

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA to include risk mitigation measures as referred to in paragraph 3. The competent authority shall also request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment.

Or. en

Amendment 642

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 6 – subparagraph 2

Text proposed by the Commission

Amendment

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment.

Or. en

Amendment 643

Margrete Auken

Proposal for a directive

Article 22 – paragraph 6 – subparagraph 2

Text proposed by the Commission

Amendment

For an ERA conducted prior to [OP please insert the date = 18 months after the date of entering into force of this Directive], the competent authority shall request the marketing authorisation holder to update the ERA if missing information has been identified for medicinal products potentially harmful to the environment.

Or. en

Amendment 644

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 22 – paragraph 7

Text proposed by the Commission

Amendment

7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERA.

7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines referred to in the paragraph 5.

Or. en

Amendment 645

Margrete Auken

Proposal for a directive

Article 22 – paragraph 7

Text proposed by the Commission

Amendment

7. For medicinal products referred to in Articles 9 to 12, the applicant may refer to ERA studies conducted for the reference medicinal product when preparing the ERA.

7. For medicinal products referred to in Articles 9 to 12, the applicant may, where appropriate, refer to ERA studies conducted for the reference medicinal product when preparing the ERA and shall provide any other data required in accordance with Annex II and the scientific guidelines as referred to in the first paragraph.

Or. en

Amendment 646

Heléne Fritzon

Proposal for a directive

Article 22 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. The marketing authorisation holder shall ensure that package sizes of the medicinal product correspond to usual dosing and treatment durations and comprehensive shelf-life documentation of the finished, and where applicable, intermediate as well as ready-to-use medicinal product is provided. The Agency may, on its own initiative or upon request of the competent authority of a Member State require the marketing authorisation holder to develop additional package sizes and provide for additional in-use shelf-life data as necessary.

Or. en

Justification

Amendment 647

Margrete Auken

Proposal for a directive

Article 22 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. In line with the Aarhus Convention3a, full environmental assessment studies and summaries with outcomes shall be made publicly available and proactively shared with drinking water and wastewater operators. The competent authorities shall include this information in their repository of medicinal products.

_________________

3a UN Convention on access to information, public participation in decision-making and access to justice in environmental matters, done at Aarhus, Denmark, on 25 June 1998.

Or. en

Amendment 648

Catherine Amalric

Proposal for a directive

Article 22 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. The results of the ERA assessment, including data provided by the marketing authorisation holder, shall be made publicly available by the Agency or, where appropriate, by the competent authority of the Member State after deletion of any information of a commercially confidential nature.

Or. en

Amendment 649

Sirpa Pietikäinen

Proposal for a directive

Article 22 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. Priority in market authorisation shall be given to pharmaceuticals that are proven to have less harmful impacts on environment than their equivalents.

Or. en

Amendment 650

Catherine Amalric

Proposal for a directive

Article 22 – paragraph 7 b (new)

Text proposed by the Commission

Amendment

7 b. With regard to medicinal products referred to in Articles 9 to 12, the applicant may take into account the ERAs carried out for the reference medicinal product when carrying out the ERA.The Commission is empowered to adopt delegated acts in accordance with Article 215, in order to supplement this Directive by specifying:

a) reference methodologies for assessing the greenhouse gas emissions footprint of the production and use of the medicinal product;

(b) the minimum data on which to base the assessment of the greenhouse gas emissions footprint of the production and use of the medicinal product;

(c) reference methodologies for the assessment of environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product;

d) the minimum data on which to base the assessment of the environmental impacts, excluding greenhouse gas emissions, associated with the production, use and dissemination of the medicinal product.

Or. en

Amendment 651

Kateřina Konečná

Proposal for a directive

Article 22 a (new)

Text proposed by the Commission

Amendment

Article 22a

General requirements for marketing authorisation applications

Pursuant to article 6(2), the marketing authorisation applicant shall include patient experience data in the marketing application dossier. Where this is not possible, the marketing authorisation applicant should provide a detailed justification to the Agency. The Agency, in collaboration with patient organisations, competent authorities of the Member States and other relevant parties, shall draw up guidance to design, conduct, analyse, and report relevant studies incorporating robust and meaningful patient experience data for regulatory submission.

Or. en

Justification

Authorised medicines must respond to patients' needs. Patient-relevant outcomes and other patient experience data should be included in the marketing authorisation dossier, which would oblige pharmaceutical companies to fully involve patients from the start and in the design of the studies, and to fully integrate the parameters that matter most to patients into their development plans. Unfortunately, meaningful patient involvement is far from being a reality. Many clinical trials still do not include outcomes that matter to patients, such as quality of life indicators.

Amendment 652

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 22 a (new)

Text proposed by the Commission

Amendment

Article 22a

In accordance with Article 6(2), applicants for marketing authorization are required to incorporate data on patient experiences within their application dossiers. If inclusion of such data is not feasible, applicants must present a comprehensive explanation to the Agency. The Agency shall cooperate with patient organizations, Member State authorities, and other pertinent entities to develop guidance on the creation, execution, analysis, and reporting of studies that integrate substantial and significant patient experience data for regulatory purposes.

Or. en

Amendment 653

Margrete Auken

Proposal for a directive

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

By [OP please insert the date = 12 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Centre for Disease Prevention and Control (ECDC), the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Or. en

Amendment 654

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By [OP please insert the date = 12 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Or. en

Amendment 655

Sirpa Pietikäinen

Proposal for a directive

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By [OP please insert the date = 24 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified as potentially harmful to the environment in accordance with paragraph 2.

Or. en

Amendment 656

Fulvio Martusciello

Proposal for a directive

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

By [OP please insert the date = 30 months after the date of the entry into force of this Directive] the Agency shall, after consultation with the competent authorities of the Member States, the European Chemical Agency (ECHA), the European Food Safety Authority (EFSA) and the European Environmental Agency (EEA), establish a programme for the ERA to be submitted in accordance with Article 22 of the medicinal products authorised before 30 October 2005 that have not been subject to any ERA and that the Agency has identified to potentially cause a risk to the environment by risk-based prioritisation in accordance with paragraph 2.

Or. en

Amendment 657

Stanislav Polčák

Proposal for a directive

Article 23 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

This programme shall be made publicly available by the Agency.

This programme shall be made publicly available by the Agency and, if necessary, updated.

Or. cs

Amendment 658

Sirpa Pietikäinen

Proposal for a directive

Article 23 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency shall consult relevant stakeholders including drinking water and wastewater operators and may request from marketing authorisation holders the submission of relevant data or information.

Or. en

Amendment 659

Margrete Auken

Proposal for a directive

Article 23 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially harmful to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency shall consult all relevant stakeholders and request from marketing authorisation holders the submission of relevant data or information.

Or. en

Amendment 660

Fulvio Martusciello

Proposal for a directive

Article 23 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency shall set the scientific criteria for the identification of the medicinal products that potentially cause a risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.

Or. en

Amendment 661

Margarita de la Pisa Carrión

Proposal for a directive

Article 23 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency shall set the scientific criteria for the identification of the medicinal products as potentially risk to the environment and for the prioritisation of their ERA, using a risk based approach. For this task, the Agency may request from marketing authorisation holders the submission of relevant data or information.

Or. en

Amendment 662

Margrete Auken

Proposal for a directive

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder, including full data sets and summaries of conducted ERA studies, shall be made publicly available by the Agency and shall be proactively shared with drinking water and wastewater operators.

Or. en

Amendment 663

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including a summary of ERA studies and their results as submitted by the marketing authorisation holder and the assessment of the ERA and scientific guidelines referred to in Article 22(5) shall be made publicly available by the Agency.

Or. en

Amendment 664

Stanislav Polčák

Proposal for a directive

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

3. The marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency within the time limit set for the medicinal product in the programme. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.

Or. cs

Amendment 665

Fulvio Martusciello

Proposal for a directive

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

3. The current marketing authorisation holders for medicinal products identified in the programme referred to in paragraph 1 shall submit the ERA to the Agency. The outcome of the assessment of the ERA including the data submitted by the marketing authorisation holder shall be made publicly available by the Agency.

Or. en

Amendment 666

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 23 – paragraph 4

Text proposed by the Commission

Amendment

4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall inform and recommend the marketing authorisation holders of the possibility to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals. In this regard, to facilitate and foster the increased use of joint studies, the Agency shall oversee these in a cooridnating role, where necessary and appropriate.

Or. en

Amendment 667

Fulvio Martusciello

Proposal for a directive

Article 23 – paragraph 4

Text proposed by the Commission

Amendment

4. Where there are several medicinal products identified in the programme referred to in paragraph 1 that contain the same active substance and that are expected to pose the same risks to the environment, the competent authorities of the Member States or the Agency shall encourage the marketing authorisation holders to conduct joint studies for the ERA, to minimise unnecessary duplication of data and use of animals, specifically to avoid unnecessary testing of vertebrate species and to follow the 3R rule.

Or. en

Amendment 668

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

Proposal for a directive

Article 23 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Agency shall ensure that the ERA is followed by clear recommandations to the marketing authorisation holders on how to respect the guidelines and to fulfill the requirements in the future.

Or. en

Amendment 669

Sirpa Pietikäinen

Proposal for a directive

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

1. The Agency shall, in collaboration with the competent authorities of the Member States, set-up an active substance based review system of ERA data (‘ERA monographs’) for authorised medicinal products. An ERA monograph shall include a comprehensive set of physiochemical data, fate data and effect data based on an assessment of a competent authority.

1. The Agency shall, in collaboration with the competent authorities of the Member States, set-up an active, public substance based review system of ERA data (‘ERA monographs’) for authorised medicinal products. An ERA monograph shall include a comprehensive set of physiochemical data, fate data and effect data based on an assessment of a competent authority.

Or. en

Amendment 670

Fulvio Martusciello

Proposal for a directive

Article 24 – paragraph 2

Text proposed by the Commission

Amendment

2. The setting-up of the system of ERA monographs shall be based on a risk-based prioritisation of active substances.

2. The setting-up of the system of ERA monographs shall be based on a risk-based prioritisation of active substances and relevant data requirements, particularly considering vertebrate studies.

Or. en

Amendment 671

Fulvio Martusciello

Proposal for a directive

Article 24 – paragraph 3

Text proposed by the Commission

Amendment

3. In the preparation of the ERA monograph referred to in paragraph 1, the Agency may request information, studies and data from competent authorities of the Member States and from marketing authorisation holders.

3. In the preparation of the ERA monograph referred to in paragraph 1, the Agency may request existing information, studies and data from competent authorities of the Member States and from marketing authorisation holders.

Or. en

Amendment 672

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 24 – paragraph 4

Text proposed by the Commission

Amendment

4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within three years after entering into force of this Directive.

4. The Agency in cooperation with the competent authorities of the Member States shall conduct a proof-of-concept pilot of ERA monographs to be completed within two years after entering into force of this Directive.

Or. en

Amendment 673

Fulvio Martusciello

Proposal for a directive

Article 24 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 674

Fulvio Martusciello

Proposal for a directive

Article 24 – paragraph 5 – point e a (new)

Text proposed by the Commission

Amendment

(e a) risk-based prioritisation of data requirements for active substances to avoid unnecessary testing, particularly in-line with directive 2010/63/EU.

Or. en

Amendment 675

Margrete Auken

Proposal for a directive

Article 25 – paragraph 6 – subparagraph 2

Text proposed by the Commission

Amendment

If the manufacturer of an active substance refuses to undergo such an inspection, the Agency may suspend or terminate the application for an active substance master file certificate.

If the manufacturer of an active substance refuses to undergo such an inspection, the Agency shall suspend or terminate the application for an active substance master file certificate.

Or. en

Amendment 676

Margrete Auken

Proposal for a directive

Article 25 – paragraph 7

Text proposed by the Commission

Amendment

7. If the active substance master file certificate holder does not fulfil the obligations set out in the paragraphs 5 and 6, the Agency may suspend or withdraw the certificate and, the competent authorities of the Member States may suspend or revoke the marketing authorisation of a medicinal product relying on that certificate or take measures to prohibit the supply of the medicinal product relying on that certificate.

7. If the active substance master file certificate holder does not fulfil the obligations set out in the paragraphs 5 and 6, the Agency shall suspend or withdraw the certificate and, the competent authorities of the Member States shall suspend or revoke the marketing authorisation of a medicinal product relying on that certificate or take measures to prohibit the supply of the medicinal product relying on that certificate.

Or. en

Amendment 677

Billy Kelleher, Ondřej Knotek

Proposal for a directive

Article 26 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Marketing authorisation applicants may, instead of submitting the relevant data on the quality, safety and/or efficacy of a medicinal product required in accordance with Annex II, rely on an additional platform technology master file or a platform technology master file certificate granted by the Agency in accordance with this Article (‘platform technology master file certificate’).

Or. en

Amendment 678

Susana Solís Pérez, Catherine Amalric, Ondřej Knotek

Proposal for a directive

Article 26 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance present or used in the manufacture of a medicinal product;

(b) additional quality master files for which a certificate may be used in order to provide specific information on the quality of a substance, preparation or other material present or used in the manufacture of a medicinal product including cell and gene therapies;

Or. en

Amendment 679

István Ujhelyi

Proposal for a directive

Article 26 – paragraph 3 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 680

Margrete Auken

Proposal for a directive

Article 26 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

If the manufacturer of this substance refuses to undergo such an inspection, the Agency may suspend or terminate the application for the additional quality master file certificate.

If the manufacturer of this substance refuses to undergo such an inspection, the Agency shall suspend or terminate the application for the additional quality master file certificate.

Or. en

Amendment 681

Margrete Auken

Proposal for a directive

Article 27 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Colours shall be used in medicinal products only if they are included in one of the following lists:

2. Colours shall be used in medicinal products only if they are included in the Union list of authorised food additives in Table 1 in Part B of Annex II to Regulation (EC) No 1333/2008 and comply with the purity criteria and specifications laid down in Commission Regulation (EU) No 231/2012.

Or. en

Amendment 682

Margrete Auken

Proposal for a directive

Article 27 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the Union list of authorised food additives in Table 1 in Part B of Annex II to Regulation (EC) No 1333/2008 and comply with the purity criteria and specifications laid down in Commission Regulation (EU) No 231/2012;

deleted

Or. en

Amendment 683

Margrete Auken

Proposal for a directive

Article 27 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) the list established by the Commission pursuant to paragraph 3.

deleted

Or. en

Amendment 684

Margrete Auken

Proposal for a directive

Article 27 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission may establish a list of colours permitted for use in medicinal products other than those included in the Union list of authorised food additives.

By way of derogation from paragraph 2, in duly justified cases, the Commission may establish a list of colours permitted for use in medicinal products other than those included in the Union list of authorised food additives.

Or. en

Amendment 685

Margrete Auken

Proposal for a directive

Article 27 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Addition of substances on the list referred to in paragraph three shall be limited to maximum five years. Within that period, marketing authorisation holders who use the excipients shall conduct studies to ensure use of available alternatives complying with the conditions set out in paragraph 2.

Or. en

Amendment 686

Margrete Auken

Proposal for a directive

Article 27 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

If a colour used in medicinal product is removed from the Union list of authorised food additives, on the basis of the scientific opinion of the European Food Safety Authority (‘EFSA’), the Agency shall, on the request of the Commission or on its own initiative, without undue delay issue a scientific opinion as regards the use of the colour concerned in medicinal product, taking into account the opinion of the EFSA if relevant. The opinion of the Agency shall be adopted by the Committee for Medicinal Products for Human Use.

If a colour used in medicinal product is removed from the Union list of authorised food additives, on the basis of the scientific opinion of the European Food Safety Authority (‘EFSA’), the Agency shall, on the request of the Commission or on its own initiative, without undue delay issue a scientific opinion as regards the use of the colour concerned in medicinal product, taking into account the opinion of the EFSA. The opinion of the Agency shall be adopted by the Committee for Medicinal Products for Human Use.

Or. en

Amendment 687

Margrete Auken

Proposal for a directive

Article 27 – paragraph 5

Text proposed by the Commission

Amendment

5. If a colour has been removed from the Union list of authorised food additives for reasons that do not require an EFSA opinion, the Commission shall decide on the use of the colour concerned in medicinal products and, where applicable, include it in the list of colours permitted for use in medicinal products referred to in paragraph 3. The Commission may, in such cases, request the opinion from the Agency.

5. If a colour has been removed from the Union list of authorised food additives for reasons that do not require an EFSA opinion, the Commission shall decide on the use of the colour concerned in medicinal products and, where applicable, include it in the list of colours permitted for use in medicinal products referred to in paragraph 3. The Commission shall, in such cases, request the opinion from the Agency.

Or. en

Amendment 688

Margrete Auken

Proposal for a directive

Article 27 – paragraph 6

Text proposed by the Commission

Amendment

6. A colour that has been removed from the Union list of authorised food additives can still be used as a colour in medicinal products until the Commission takes the decision on whether to include the colour on the list of colours permitted for use in medicinal products in accordance with paragraph 3.

6. A colour that has been removed from the Union list of authorised food additives can still be used as a colour in medicinal products for a maximum of two years until the Commission takes the decision on whether to include the colour on the list of colours permitted for use in medicinal products in accordance with paragraph 3.

Or. en

Amendment 689

Margrete Auken

Proposal for a directive

Article 27 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. The Agency shall draw up an updated list of excipients used in medicines, based on an in-depth evaluation, in particular with regard to their risks in children and pregnant women.

Or. en

Justification

Pending obligation of the Agency since 2010

Amendment 690

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 28 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) the creation of the product occurred within a regulatory sandbox as outlined by Article 114 (2) of [revised Regulation (EC) No 726/2004], unless exceptions are warranted by scientific and technical reasoning.

Or. en

Amendment 691

Margrete Auken

Proposal for a directive

Article 28 – paragraph 6

Text proposed by the Commission

Amendment

6. When adopting delegated acts referred to in this Article, the Commission shall take into account any available information resulting from a regulatory sandbox established in accordance with Article 115 of the [revised Regulation (EC) No 726/2004].

deleted

Or. en

Amendment 692

Heléne Fritzon

Proposal for a directive

Article 28 – paragraph 6

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Sandboxes would provide yet another adapted/accelerated pathway mechanism, with limited capacity to ensure quality, safety and efficacy as they could potentially deviate from traditional authorisation pathways and evidence requirements. They may provide for authorisation based on real-world evidence, whereas randomised controlled trials with an active comparator shall remain the gold standard.

Amendment 693

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 28 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. When enacting delegated acts under this Article, the Commission shall engage in dialogue with the Agency, national competent authorities, the Pharmaceutical Committee, and pertinent interested parties.

Or. en

Amendment 694

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Article 28 – paragraph 6 b (new)

Text proposed by the Commission

Amendment

6 b. The Commission shall submit a report on the acquired experience with adapted frameworks to the European Parliament and the Council of the European Union. The first report is due five years following [insert date = 18 months post-implementation of this Directive] and on a five-year cycle subsequently. Based on the report's findings, the Commission may propose legislative changes to the overarching pharmaceutical laws, reflecting the practical insights gained from employing adapted frameworks. d frameworks.

Or. en

Amendment 695

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 29 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) shall verify whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

(a) shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Or. en

Amendment 696

Margrete Auken

Proposal for a directive

Article 29 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 697

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn.

3. Where the competent authority of the Member State considers that the marketing authorisation application is incomplete, or contains critical deficiencies that may prevent the evaluation of the medicinal product it shall inform the applicant accordingly and shall set a time limit of minimum 14 days for submitting the missing information and documentation. If the applicant fails to provide the missing information and documentation within the time limit set, the application shall be considered to have been withdrawn by default.

Or. en

Amendment 698

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 29 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn.

The competent authority of the Member State shall summarise the deficiencies in writing. On this basis, the competent authority of the Member State shall inform the applicant accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the Member State, the application shall be considered as withdrawn by default.

Or. en

Amendment 699

Michèle Rivasi

Proposal for a directive

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days after the submission of a valid application from the date of validation of a marketing authorisation application.

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 210 days (excluding clock-stops) after the submission of a valid application from the date of validation of a marketing authorisation application.

Or. en

Justification

Reducing the assessment time may be detrimental to patient safety and does not solve the current problem of lengthy clock-stops. The scientific evaluation of the application of marketing authorisation constitutes a key task of the EMA and national agencies and should in no way be presented as an administrative hurdle. Lack of sufficient time for the assessment may lead to risky decisions. Instead of reducing assessment timelines, the MA applicants should be required to make sure that all data and documents are included in the application file for a MA so that a swift evaluation procedure can be launched without being interrupted with lengthy clock-stops. The long assessment timelines are caused by the clock-stops due to incomplete application files provided by MA applicants. Research on FDA practice with shorter regulatory review timelines stressed that accelerated approval was associated with an increased risk of FDA safety actions after the approval for new drugs. (JAMA: US FDA review time of supplemental new indication approvals of drugs and biologics, 2017 to 2019).

Amendment 700

Marian-Jean Marinescu

Proposal for a directive

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

Enforcement of Council Directive 89/105/EEC, the so-called “Transparency Directive” would ensure a faster access to medicines

Amendment 701

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 180 days (excluding clock stops) after the submission of a valid application from the date of validation of a marketing authorisation application.

Or. en

Amendment 702

Margrete Auken

Proposal for a directive

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority in the Member State concerned shall examine the application in accordance with Articles 29 and 30 and grant a marketing authorisation in accordance with Articles 43 to 45 and applicable national provisions.

Or. en

Amendment 703

Margrete Auken

Proposal for a directive

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authorities in the Member State concerned shall examine the applications in accordance with Articles 29, 30 and 34 and grant a marketing authorisation in accordance with Articles 43 to 45.

Or. en

Amendment 704

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 34 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

3. Based on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to recognise the procedure within 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the decentralised procedure. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Or. en

Amendment 705

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 34 – paragraph 3

Text proposed by the Commission

Amendment

3. The applicant shall inform all the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State shall have the possibility to to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Or. en

Amendment 706

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 34 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.

The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as refused.

Or. en

Amendment 707

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 34 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

The competent authority of the reference Member State for the decentralised procedure shall summarise the deficiencies in writing. On this basis, the competent authority of the reference Member State for the decentralised procedure shall inform the applicant and the competent authorities of the Member States concerned accordingly and set a time limit of minimum 14 days to address the deficiencies. The application shall be suspended until the applicant addresses the deficiencies. If the applicant fails to address those deficiencies within the time limit set by the competent authority of the reference Member State for the decentralised procedure, the application shall be considered as withdrawn.

Or. en

Amendment 708

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 34 – paragraph 5

Text proposed by the Commission

Amendment

5. Within 90 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant.

Or. en

Amendment 709

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 34 – paragraph 5

Text proposed by the Commission

Amendment

5. Within 120 days after validation of the application, the competent authority of the reference Member State for the decentralised procedure shall prepare an assessment report, a summary of product characteristics, the labelling and the package leaflet and shall send them to the Member States concerned and to the applicant. During this period, a competent authority of a Member State may request to recognise and enter the procedure after validation and shall inform the applicant and the competent authority of the reference Member State for the decentralised procedure.

Or. en

Amendment 710

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 34 – paragraph 6

Text proposed by the Commission

Amendment

6. Within 60 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the competent authority of the reference Member State for the decentralised procedure accordingly. The competent authority of the reference Member State for the decentralised procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

6. Within 90 days of receipt of the assessment report, the competent authorities of the Member States concerned shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the competent authority of the reference Member State for the decentralised procedure accordingly. The competent authority of the reference Member State for the decentralised procedure shall record the agreement of all parties, close the procedure and inform the applicant accordingly.

Or. en

Amendment 711

Margrete Auken

Proposal for a directive

Article 35 – paragraph 1

Text proposed by the Commission

Amendment

An application for marketing authorisation for mutual recognition procedure for national marketing authorisation, granted under Articles 43 to 45 and in accordance with Article 32, shall be submitted to the competent authorities of other Member States in accordance with the procedure laid down in Article 36.

An application for marketing authorisation for mutual recognition procedure for national marketing authorisation, granted under Articles 43 to 44 and in accordance with Article 32, shall be submitted to the competent authorities of other Member States in accordance with the procedure laid down in Article 36.

Or. en

Amendment 712

Margrete Auken

Proposal for a directive

Article 36 – paragraph 1

Text proposed by the Commission

Amendment

1. An application for mutual recognition of a marketing authorisation, granted under Articles 43 to 45 and in accordance with Article 32, in several Member States in respect of the same medicinal product shall be submitted to the competent authority of the Member State that granted the marketing authorisation (‘reference Member State for the mutual recognition procedure’) and to the competent authorities of the Member States concerned where the applicant seeks to obtain a national marketing authorisation.

1. An application for mutual recognition of a marketing authorisation, granted under Articles 43 to 44 and in accordance with Article 32, in several Member States in respect of the same medicinal product shall be submitted to the competent authority of the Member State that granted the marketing authorisation (‘reference Member State for the mutual recognition procedure’) and to the competent authorities of the Member States concerned where the applicant seeks to obtain a national marketing authorisation.

Or. en

Amendment 713

Dolors Montserrat, Nathalie Colin-Oesterlé

Proposal for a directive

Article 36 – paragraph 4

Text proposed by the Commission

Amendment

4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State may request for justified public health reasons to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

4. Based on information made available by the Coordination group for decentralised and mutual recognition procedures, the competent authority of a Member State may request for justified public health reasons to recognise the procedure within 15 days after the procedure has been closed, upon agreement with the applicant and the competent authority of the reference Member State for the mutual recognition procedure. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Or. en

Amendment 714

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 36 – paragraph 4

Text proposed by the Commission

Amendment

4. The applicant shall inform the competent authorities of all Member States of its application at the time of submission. The competent authority of a Member State shall have the possibility to enter the procedure and shall inform the applicant and the competent authority of the reference Member State for the mutual recognition procedure of its request within 30 days from the date of submission of the application. The applicant shall provide the competent authorities of those Member States entering the procedure with the application without undue delay.

Or. en

Amendment 715

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 36 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 30 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Or. en

Amendment 716

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 36 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. In order to examine an application submitted in accordance with Articles 6 and 9 to 14, the competent authorities of the Member States shall verify within 20 days whether the particulars and documentations submitted in support of the application comply with Articles 6 and 9 to 14 (‘validation’), and examine whether the conditions for issuing a marketing authorisation set out in Articles 43 to 45 are complied with;

Or. en

Amendment 717

Joanna Kopcińska

Proposal for a directive

Article 36 – paragraph 5

Text proposed by the Commission

Amendment

5. If the competent authorities of the Member States concerned so require, the marketing authorisation holder shall request the competent authority of the reference Member State for the mutual recognition procedure to update the assessment report drawn on the medicinal concerned by the application. In that case, the reference Member State shall update the assessment report within 90 days after validation of the application. If the competent authorities of the Member States concerned do not require the update of the assessment report, the reference Member State shall provide the assessment report within 30 days.

5. If the competent authorities of the Member States concerned so require, the marketing authorisation holder shall request the competent authority of the reference Member State for the mutual recognition procedure to perform or update the assessment report drawn on the medicinal concerned by the application. In that case, the reference Member State shall perform or update the assessment report within 90 days after validation of the application. If the competent authorities of the Member States concerned do not require the performance or the update of the assessment report, the reference Member State shall provide the assessment report within 30 days in case medicinal product was previously authorised in European procedure.

Or. en

Amendment 718

Margrete Auken

Proposal for a directive

Article 36 – paragraph 8

Text proposed by the Commission

Amendment

8. Within 30 days after acknowledgement of the agreement, the competent authorities of all Member States concerned in which an application has been submitted in accordance with paragraph 1 shall adopt a decision according to Articles 43 to 45 in conformity with the approved assessment report, the summary of product characteristics, the labelling and package leaflet as approved.

8. Within 30 days after acknowledgement of the agreement, the competent authorities of all Member States concerned in which an application has been submitted in accordance with paragraph 1 shall adopt a decision according to Articles 43 to 44 in conformity with the approved assessment report, the summary of product characteristics, the labelling and package leaflet as approved.

Or. en

Amendment 719

Kateřina Konečná

Proposal for a directive

Article 37 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The coordination group shall be composed of one representative per Member State appointed for a renewable period of three years. Member States may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States and patients may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

Or. en

Justification

Patients’ organisations, especially those operating at the EU level, have practical knowledge of medicines requiring harmonised product information as the patients they represent may receive care in different Member States. Therefore, representatives of patients’ organisations would bring to the coordination group the important perspective of users and patients. This will further ensure that patients are involved throughout the regulatory cycle of medicines that are not centrally approved, beyond being ad hoc experts.

Amendment 720

Susana Solís Pérez

Proposal for a directive

Article 37 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The coordination group shall be composed of one representative per Member State and one representative from patients’ organisations appointed for a renewable period of three years. Member States may appoint an alternate for a renewable period of three years. Members of the coordination group may arrange to be accompanied by experts.

Or. en

Amendment 721

Margrete Auken

Proposal for a directive

Article 42 – paragraph 1 – subparagraph 4

Text proposed by the Commission

Amendment

Where a draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences.

Where, in exceptional circumstances, a draft decision differs from the opinion of the Agency, the Commission shall provide a detailed explanation of the reasons for the differences.

Or. en

Amendment 722

Margrete Auken

Proposal for a directive

Article 42 – paragraph 1 – subparagraph 5

Text proposed by the Commission

Amendment

The Commission shall send the draft decision to the competent authorities of the Member States and the applicant or the marketing authorisation holder.

The Commission shall send the draft decision to the competent authorities of the Member States and the applicant or the marketing authorisation holder and make the decision, including the justification, publicly available.

Or. en

Amendment 723

Margarita de la Pisa Carrión

Proposal for a directive

Article 42 – paragraph 1 – subparagraph 5 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

Justification

Propose to add the 10 days (maximum) timeline for the Standing Committee, as indicated in recitals 147 of the Directive and 50 of the Regulation, as it is not mentioned in the binding provisions of the Directive or Regulation. In line with other principles to reduce the bureaucratic decision-making timeline, the Directive should explicitly mention in Article 42 that the maximum timeline for Standing Committee should not exceed 10 days. A confirmation in the reduction of the Standing Committee timelines contributes to narrowing the gaps for regulatory decision making with other regions.

Amendment 724

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 43 – paragraph 3

Text proposed by the Commission

Amendment

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the antimicrobial stewardship plan and special information requirements referred to in Article 17 (1), as well as any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Or. en

Amendment 725

Margrete Auken

Proposal for a directive

Article 43 – paragraph 3

Text proposed by the Commission

Amendment

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the labelling, the package leaflet, the information related to antimicrobials referred to in Article 17(1), where applicable, as well as any conditions established in accordance with Article 44 and any obligations imposed subsequently in accordance with Article 17(2) and 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Or. en

Amendment 726

Kateřina Konečná

Proposal for a directive

Article 43 – paragraph 3

Text proposed by the Commission

Amendment

3. The competent authorities of the Member States shall, without undue delay, make publicly available the national marketing authorisation together with the summary of product characteristics, the package leaflet, the information referred to in Article 17 (1) for antimicrobials, and any conditions established in accordance with Articles 44, 45 and any obligations imposed subsequently in accordance with Article 17 (2) and Article 87, together with any deadlines for the fulfilment of those conditions and obligations for each medicinal product that they have authorised.

Or. en

Justification

For transparency and accountability purposes, when a new antimicrobial is authorised, the competent authorities should make publicly available the stewardship plan and any imposed obligations to the marketing authorisation holder in relation to such plan, as well as the validated educational material for healthcare professionals and the patient awareness card.

Amendment 727

Margarita de la Pisa Carrión

Proposal for a directive

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

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

4. The relevant authority in the Member State has the discretion to consider additional high-quality evidence sources, alongside the evidence provided by the marketing authorization holder, for its scientific evaluation. If, after reviewing all evidence, including any supplementary information, the authority deems a modification to the product's summary of characteristics necessary due to its impact on the product's benefit-risk balance within its approved uses, it shall promptly communicate its suggestion to the marketing authorization holder. The holder shall receive all extra evidence and related study documents that the proposal is based on. They shall also be asked to present their viewpoint on the provided evidence and, if required, shall have the chance for an oral discussion regarding any proposed updates to the product summary with the authority. The authority shall inform the marketing authorization holder of its decision without unnecessary delay. If the marketing authorization holder disagrees with the authority's decision, they may request a re-evaluation in writing. Upon such a request, the authority shall immediately notify the Agency, providing a detailed account of the unresolved issues and reasons for disagreement, with a copy sent to the holder. Once the holder is informed that the Agency is involved, they shall promptly submit their detailed reasons for the request to the Agency. Within 30 days of receiving these grounds, the Agency shall review the authority's decision and issue a conclusive opinion, including the rationale for its conclusion. If the Agency's final opinion necessitates a change in the product's summary of characteristics, this summary shall be accordingly updated.

Or. en

Amendment 728

Margarita de la Pisa Carrión

Proposal for a directive

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

5. The competent authorities of the Member States shall draw up an assessment report and make comments on the file as regards the results of the pharmaceutical and non-clinical tests, the clinical studies, the risk management system, the environmental risk assessment and the pharmacovigilance system of the medicinal product concerned. For expedited review processes, competent authorities shall agree binding timelines with the applicants to provide a full ERA after receiving the marketing authorisation.

Or. en

Amendment 729

Fulvio Martusciello

Proposal for a directive

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Amendment 730

Nicola Procaccini

Proposal for a directive

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Amendment 731

Alessandra Moretti

Proposal for a directive

Article 43 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each therapeutic indication applied for.

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, including information of a commercially confidential nature if their disclosure is in the public interest or relevant for public health reasons. The justification shall be provided separately for each therapeutic indication applied for.

Or. en

Amendment 732

Kateřina Konečná

Proposal for a directive

Article 43 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.

Or. en

Justification

To safeguard public trust in the marketing authorisation system, it is important that competent authorities are transparent about their decisions and the underlying data upon which they base their opinions. To that end, public interest considerations should go before confidentiality and the commercial interest of pharmaceutical companies.

Amendment 733

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 43 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authorities of the Member States shall make the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure. The justification shall be provided separately for each therapeutic indication applied for.

Or. en

Amendment 734

Sirpa Pietikäinen

Proposal for a directive

Article 43 – paragraph 6

Text proposed by the Commission

Amendment

6. The competent authorities of the Member States shall make the environmental risk assessment and its the assessment report publicly available without undue delay, together with the reasons for their opinion, after deletion of any information of a commercially confidential nature. The justification shall be provided separately for each therapeutic indication applied for.

Or. en

Amendment 735

Margrete Auken

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point e a (new)

Text proposed by the Commission

Amendment

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

Or. en

Amendment 736

Heléne Fritzon

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point f

Text proposed by the Commission

Amendment

(f) to conduct post-authorisation efficacy studies where concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed;

Or. en

Justification

The proposal sets out requirements for post-launch evidence generation (PLEG), without mentioning penalties for non-compliance. To strengthen PLEG requirements, the Committee opinion on marketing authorisation should refer to penalties for non-compliance with the obligation to conduct post-authorisation studies. Such penalties should include revocation of marketing authorization , by way of derogation from the proposed regulations article 17, paragraph 1, if PLEG studies are not completed within the defined timeline, unless duly substantiated with scientific reasons.

Amendment 737

Heléne Fritzon

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point g

Text proposed by the Commission

Amendment

(g) 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;

deleted

Or. sv

Justification

A surrogate endpoint for which there is substantial uncertainty about its link with the expected clinical benefit cannot be regarded as a validated surrogate endpoint. In the absence of data proving relevant benefits for the medical product concerned, the benefit-risk balance for it cannot be considered favourable. The provision would instead make it possible for products to be authorised in the absence of sufficient certainty regarding the relevance of the surrogate endpoint.

Amendment 738

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point g

Text proposed by the Commission

Amendment

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

Or. en

Amendment 739

Kateřina Konečná

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point g

Text proposed by the Commission

Amendment

(g) 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 740

Margrete Auken

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point g

Text proposed by the Commission

Amendment

(g) in case of medicinal products for which, on duly justified grounds submitted to the national competent authority, 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

Amendment 741

Joanna Kopcińska

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point g

Text proposed by the Commission

Amendment

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

Or. en

Justification

authorisation based on substantial uncertainty shoul always be a ground for authorisation subject to conditions

Amendment 742

Fulvio Martusciello

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point h

Text proposed by the Commission

Amendment

(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment or public health, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

Or. en

Amendment 743

Nicola Procaccini

Proposal for a directive

Article 44 – paragraph 1 – subparagraph 1 – point h

Text proposed by the Commission

Amendment

(h) to conduct post-authorisation environmental risk assessment studies, collection of monitoring data or information on use, where identified or potential concerns about risks to the environment, including antimicrobial resistance need to be further investigated after the medicinal product has been marketed;

Or. en

Amendment 744

Margrete Auken

Proposal for a directive

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph, where necessary.

2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph.

Or. en

Amendment 745

Maria Angela Danzì

Proposal for a directive

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph, where necessary.

2. The marketing authorisation shall lay down deadlines for the fulfilment of the conditions referred to in paragraph 1, first subparagraph.

Or. en

Justification

The specific obligations related to the conditional marketing authorisation shall be subject to a specific and mandatory deadline. As the conditional marketing authorisation is granted prior to the submission of comprehensive clinical data, it is essential to confirm in a reasonable timeframe that the benefit-risk balance is favourable. The same applies to possible post-authorisation studies that might be imposed on the marketing authorisation holder and might constitute an obligation as a condition of a marketing authorisation.

Amendment 746

Margrete Auken

Proposal for a directive

Article 45

Text proposed by the Commission

Amendment

Article 45

deleted

National marketing authorisation under exceptional circumstances

1. In exceptional circumstances where, in an application under Article 6 for a marketing authorisation of a medical product, or in an application under Article 92 for a new therapeutic indication of an existing marketing authorisation, an applicant is unable to provide comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use, the competent authority of the Member State may, by derogation to Article 6, grant an authorisation under Article 43, subject to specific conditions, where the following requirements are met:

(a) the applicant has demonstrated, in the application file, that there are objective and verifiable reasons not to be able to submit comprehensive data on the efficacy and safety of the medicinal product under normal conditions of use based on one of the grounds set out in Annex II;

(b) except for the data referred to in point (a), the application file is complete and satisfies all the requirements of this Directive;

(c) specific conditions are included in the decision of the competent authorities of the Member States, in particular to ensure the safety of the medicinal product as well to ensure that the marketing authorisation holder notifies to the competent authorities of the Member States any incident relating to its use and takes appropriate action where necessary.

The maintenance of the authorised new therapeutic indication and the validity of the national marketing authorisation shall be linked to the reassessment of the conditions set out 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 competent authorities of the Member State and specified in the marketing authorisation.

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.

Or. en

Justification

As this is regarding very niche products with scarce evidence, we prefer to keep these provisions solely under centralised procedure, Article 18 of the Regulation

Amendment 747

Alessandra Moretti

Proposal for a directive

Article 46 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

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 competent authority of the authorising Member State.

Or. en

Amendment 748

Margrete Auken

Proposal for a directive

Article 46 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

Without prejudice to paragraph 4 and 4a, a marketing authorisation for a medicinal product shall be valid for 5 years.

Or. en

Amendment 749

Michèle Rivasi

Proposal for a directive

Article 46 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for an unlimited period.

Without prejudice to paragraph 4, a marketing authorisation for a medicinal product shall be valid for 5 years.

Or. en

Justification

It would be unwise to grant marketing authorisations for an unlimited period, as put forward in the proposals. For an optimal and responsible use of medicines, a sound re-assessment of their benefits and risks is needed, in particular after a period of 5 years after the initial MA. The 5-year renewal should be seen as a valuable second opportunity to analyse the available data thoroughly, taken into account its use in real life situations. This goes fully in line with the EMA’s objective to assess, monitor and inform regulatory decision-making throughout the lifecycle of a medicine and the provision of up-to-date information for healthcare professionals and patients. In case of post-MA obligations, EMA or national agencies should present a detailed report on the results of post-MA obligation studies at the occasion of the 5-year renewal. A 5-year renewal should allow the Agencies to clear the market of products with poor risk-benefit balances compared to others, or of drugs whose companies fail to provide requested post-marketing studies. In case the 5-year renewal would not be upheld, then the MA should be reassessed for each new variation linked to pharmacovigilance issues. At these occasions, the EMA or national agencies should make publicly available a written notice on the benefit-risk balance stating whether it remains favourable or not.

Amendment 750

Michèle Rivasi

Proposal for a directive

Article 46 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

By way of derogation from the first subparagraph, a national marketing authorisation granted in accordance with Article 45(1) shall be valid for five years and be subject to renewal in accordance with paragraph 2.

The national marketing authorisation shall be valid for five years and be subject to renewal in accordance with paragraph 2.

Or. en

Amendment 751

Margrete Auken

Proposal for a directive

Article 46 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

By way of derogation from the first subparagraph, marketing authorisation for products referred to in Article 9 shall be valid for an unlimited period.

Or. en

Amendment 752

Margrete Auken

Proposal for a directive

Article 46 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

By way of derogation from the first subparagraph, a competent authority of the Member State may decide at the time of granting the national marketing authorisation, on objectively and duly justified grounds relating to safety of the medicinal product, to limit the validity of the national marketing authorisation to five years.

deleted

Or. en

Amendment 753

Alessandra Moretti

Proposal for a directive

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. The marketing authorisation holder may submit an application for a renewal of a national marketing authorisation granted under paragraph 1, second or third subparagraph. Such application shall be submitted at least nine months before the national marketing authorisation ceases to be valid.

2. To renew a national marketing authorisation, the marketing authorisation holder shall submit an application at least nine months before the national marketing authorisation ceases to be valid.

Or. en

Amendment 754

Margrete Auken

Proposal for a directive

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. The marketing authorisation holder shall submit an application for a renewal of a national marketing authorisation granted under paragraph 1 at least nine months before the national marketing authorisation ceases to be valid.

Or. en

Amendment 755

Margrete Auken

Proposal for a directive

Article 46 – paragraph 4

Text proposed by the Commission

Amendment

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

Or. en

Amendment 756

Margrete Auken

Proposal for a directive

Article 46 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. When an authorised product previously placed on the market in the authorising Member State is no longer actually present on the market for a period of three consecutive years, the authorisation for that product shall cease to be valid.

Or. en

Amendment 757

Margrete Auken

Proposal for a directive

Article 46 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. By way of derogation from paragraph 1 and 3, marketing authorisation for a medicinal product shall be withdrawn if the review of the post-authorisation studies referred to in Article 44 paragraph 1 result in a negative risk-benefit assessment.

Or. en

Amendment 758

Annalisa Tardino

Proposal for a directive

Article 47 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. it

Amendment 759

Margarita de la Pisa Carrión

Proposal for a directive

Article 47 – paragraph 1 – point d

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 760

Fulvio Martusciello

Proposal for a directive

Article 47 – 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 under Article 44, paragraph 1, point (h), cannot be agreed.

Or. en

Amendment 761

Nicola Procaccini

Proposal for a directive

Article 47 – 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 under Article 44, paragraph 1, point (h), cannot be agreed.

Or. en

Amendment 762

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 47 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the environmental risk assessment is incomplete or insufficiently substantiated or the reason for the imcomplete nature of the ERA are not duly justified or subtantiated by the applicant or if the risks identified in the environmental risk assessment have not been sufficiently addressed by the applicant or by the risk mitigation measures by the applicant, in accordance Article 22 (3) this Directive;

Or. en

Amendment 763

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

Proposal for a directive

Article 47 – 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 764

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Article 47 – 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 765

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Article 47 – 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, however with clear prioritization of human health benefits over risk to environment;

Or. en

Amendment 766

Sirpa Pietikäinen

Proposal for a directive

Article 47 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) there is an equivalent alternative product on the market with scientifically proven less negative environmental impacts.

Or. en

Amendment 767

Sunčana Glavak

Proposal for a directive

Article 49 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the results of all clinical studies, conducted in compliance with an agreed paediatric investigation plan as referred to in Article 6(5), point (a), shall be included in the summary of product characteristics and, if appropriate, in the package leaflet, or

(a) the results of all clinical studies, conducted in compliance with an agreed paediatric investigation plan as referred to in Article 6(5), point (a), and (aa) shall be included in the summary of product characteristics and, if appropriate, in the package leaflet, or

Or. en

Amendment 768

Margrete Auken

Proposal for a directive

Article 49 – paragraph 2

Text proposed by the Commission

Amendment

2. If the application complies with all the measures contained in the agreed completed paediatric investigation plan and if the summary of product characteristics reflects the results of studies conducted in compliance with that agreed paediatric investigation plan, the competent authority of the Member State shall include within the marketing authorisation a statement indicating compliance of the application with the agreed completed paediatric investigation plan.

Or. en

Amendment 769

Susana Solís Pérez

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antibiotic with an identified antimicrobial resistance risk; or

Or. en

Amendment 770

Maria Angela Danzì

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antibiotic or systemic antiviral or systemic antifungal;

Or. en

Justification

Restricting availability of all antimicrobials to prescription may result in unnecessary burden on health systems and on delays in care, while evidence suggests that medicines are more effective when applied earlier. Also, the potential to create resistance of topical antivirals and antifungals is very low. Antiparasitic medicines should also be subject to prescription as they can contribute to the spread of AMR.

Amendment 771

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antimicrobial of systemic administration; or

Or. en

Amendment 772

Joanna Kopcińska

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antimicrobial of systemic administration;

Or. en

Amendment 773

Nathalie Colin-Oesterlé

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antimicrobial for systemic use; or

Or. fr

Amendment 774

Margarita de la Pisa Carrión

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antimicrobial for systemic use; or

Or. en

Amendment 775

Joanna Kopcińska, Margarita de la Pisa Carrión

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antimicrobial for systemic use; or

Or. en

Amendment 776

Fulvio Martusciello

Proposal for a directive

Article 51 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) is an antimicrobial; or

(e) is an antibiotic ; or

Or. en

Amendment 777

Margrete Auken

Proposal for a directive

Article 51 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) is an antiparasitic; or

Or. en

Amendment 778

Maria Angela Danzì

Proposal for a directive

Article 51 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) is an antiparasitic; or

Or. en

Justification

Amendment 779

Joanna Kopcińska

Proposal for a directive

Article 51 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) is an antibiotic; or

Or. en

Amendment 780

Fulvio Martusciello

Proposal for a directive

Article 51 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) contains an active substance which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

(f) contains an active substance for which medical prescription is required as an agreed risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

Or. en

Amendment 781

Margrete Auken

Proposal for a directive

Article 51 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) contains an active substance, adjuvants or any other ingredient or constituent which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile, substances listed in Annex X of the Directive 2000/60/EC or individual priority substances in Annex I of the Directive 2008/105/EC for which medical prescription is required as risk minimisation measure with regard to the environment.

Or. en

Justification

Banning over-the-counter sales for medicines containing substances that are particularly harmful to the environment is an essential control-at-source measure to limit water pollution from excessive use while ensuring access to these medicines for patients who need them. The prescription requirement should apply to all substances listed in Article 22 (2) of this Directive, including endocrine disruptors which can pass untreated through most urban wastewater treatment plants and harm aquatic ecosystems.

Amendment 782

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 51 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) contains an active substance or any of its ingredients or constituent parts are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile or listed in Annex X of Directive 2000/60/EC or Annex I of Directive 2006/118/EC for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

Or. en

Amendment 783

Sirpa Pietikäinen

Proposal for a directive

Article 51 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) contains an active substance listed in Article 22, paragraph 2 of this Directive or listed as an individual priority substance in Annex I to Directive 2008/105/EC [Environmental Quality Standards Directive] and which are persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise. Emergency contraception shall be exempted from this requirement.

Or. en

Amendment 784

István Ujhelyi

Proposal for a directive

Article 51 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) contains an active substance in a concentration which are is persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, or persistent, mobile and toxic, or very persistent and very mobile for which medical prescription is required as risk minimisation measure with regard to the environment, unless the use of the medicinal product and the patient safety require otherwise.

Or. en

Amendment 785

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription or submit certain antimicrobial medicinal products to special medical prescription or restricted prescription.

Or. en

Amendment 786

Maria Angela Danzì

Proposal for a directive

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and submit certain antimicrobial medicinal products to special medical prescription or restricted prescription.

Or. en

Justification

Per-unit dispensing of antimicrobials has been listed as a core component of prudent use of antimicrobials in the EU guidelines. As the actual size of packaging of antimicrobials is difficult to adjust to all clinical guidelines, which may also change over time, the best way to dispense the needed quantity and to avoid stocking and waste is to dispense the exact number of units needed.

Amendment 787

Peter Liese, Tiemo Wölken

Proposal for a directive

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription. Member States shall ensure that the necessary capacities for appropriate testing and antigen rapid tests are available before the administration of an antibiotic substance, and shall finance such testing through their healthcare systems.

A prescription for antibiotic products shall be subject to the following conditions, which shall become effective two years after the entry into force of this Directive:

(a) be limited to the amount required for the treatment or therapy concerned;

(b) only be prescribed for a limited duration to cover the period of risk when used as prophylaxis;

(d) not be influenced by any form of economic incentive provided directly or indirectly to persons who prescribe medicinal products, given the risks associated with antimicrobial resistance.

Or. en

Amendment 788

Margrete Auken

Proposal for a directive

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that prescriptions and dispensation is aligned with the number of units required for the treatment concerned and may set additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned, restrict the use of certain antimicrobials to the use in hospitals, or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription, including the requirement that second-line treatments cannot be given before a first-line treatment. Additional measures may include mandatory training of healthcare professionals on the environmental impact of medicines use and disposal and stewardship regarding the use of antimicrobials.

Or. en

Amendment 789

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Andreas Glück

Proposal for a directive

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States may decide to make an antimicrobial other than those referred to in paragraph 1 point (e) subject to prescription, and additional conditions on the prescription of antimicrobials, restrict the validity of medical prescription and limit the quantities prescribed to the amount required for the treatment or therapy concerned by authorising the use of pre-cut blister units or submitting certain antimicrobial medicinal products to special medical prescription or restricted prescription.

Or. en

Amendment 790

Peter Liese, Tiemo Wölken

Proposal for a directive

Article 51 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Prior to the prescription of an antibiotic product, execpt in cases of emergency, the person qualified to prescribe is required to examine the sensitivity of the bacterial pathogens causing the illness (antibiogram).The antibiogram shall be conducted:

(a) in the case of treatments with antibiotics;or

(b) when changing the antibiotic product during a course of treatment;or

(c) in the case of combined adminstration of antibiotics for one indication, except for authorised ready-made products containing a combination of antibiotic active substances;

Or. en

Amendment 791

Peter Liese, Tiemo Wölken

Proposal for a directive

Article 51 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

By derogation from paragraph 2, subparagraph 1a of this article, an antibiogram is not required if:

(a) The collection of samples would involve a risk of additional impairment to the health status of the patient to be treated;or

(b) There is no suitable method available for the determination of the sensitivity of the pathogen;

If, due to an emergency or the derogations outlined above an antibiogram cannot be performed, an appropriate rapid test must be conducted whenever possible.

Or. en

Amendment 792

Maria Angela Danzì

Proposal for a directive

Article 51 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Wherever possible, Member States shall provide that prescriptions and dispensation shall be aligned with the number of units required for the treatment or therapy concerned.

Or. en

Justification

Amendment 793

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 51 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States shall, wherever possible, provide for per unit prescription and dispensing for the treatment or therapy concerned.

Or. en

Amendment 794

Joanna Kopcińska

Proposal for a directive

Article 51 – paragraph 5 – point b

Text proposed by the Commission

Amendment

(b) other circumstances of use that it has specified.

deleted

Or. en

Justification

we undermine all above efforts to build more common approach to antimicrobials thus thwarting undertaking

Amendment 795

Margrete Auken

Proposal for a directive

Article 55

Text proposed by the Commission

Amendment

Article 55

deleted

Data protection of evidence for the change of prescription status

Where a change of prescription status of a medicinal product has been authorised on the basis of significant non-clinical tests or clinical studies, the competent authority shall not refer to the results of those tests or studies when examining an application by another applicant for or marketing authorisation holder for a change of prescription status of the same substance for one year after the initial change was authorised.

Or. en

Amendment 796

Maria Angela Danzì

Proposal for a directive

Article 56 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The marketing authorisation holder shall, in good faith, file for pricing and reimbursement in the Member States in which the marketing authorisation is valid within 4 months after the marketing authorisation was granted.The marketing authorisation holder shall be exempt from this obligation provided the competent authority of the Member State grants a product specific waiver.

The obligation referred to in the first subparagraph shall exclude medicinal products defined in Article 4.1 (13), Article 10, Article 11, Article 12.

Member States representatives may request the Commission to discuss issues related to this obligation in the Committee established by Council Decision 75/320/EEC (“Pharmaceutical Committee"). The Commission might invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Or. en

Justification

Proposed incentive for launch in all Member States concerned does focus on the end results – availability of medicines – but at the same time the extension of regulatory data protection applies only to approx. 30% of medicines (where the RDP is the last period of regulatory protection). An obligation for all marketing authorisation holders to file for pricing and reimbursement, in good faith, will result in broader coverage of medicines and will push manufacturers and the Member States to negotiate fair prices and ensure availability of medicines. Proposed obligation does not cover generic and biosimilar medicinal products.

Amendment 797

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies or persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its contractual 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 the Member State in question are covered. Member States shall rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) to ensure Marketing authorisation holders comply with their supply obligations.

Or. en

Amendment 798

Cyrus Engerer

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors in accordance with Article 166 and 167, pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Or. en

Amendment 799

Margrete Auken

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall 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 the Member State in question are covered.

Or. en

Amendment 800

Maria Angela Danzì

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

The term “within the limits of its responsibility” is not clear and does not provide sufficient accountability of the marketing authorisation holders. It is common knowledge that many reasons for medicine shortages lay on the side of the marketing authorisation holder.

Amendment 801

Peter Liese

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Or. en

Justification

The current use of "or" allows authorization holders to meet their obligation by supplying to just one of the entities mentioned, which may exclude wholesale distributors from access to products. Replacing "or" with "and" would ensure wholesalers' access to supplies without disrupting direct-to-pharmacy or other distribution models.

Amendment 802

Margarita de la Pisa Carrión

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The marketing authorisation holder of a medicinal product placed on the market in a Member State shall, within the limits of its responsibility, ensure appropriate and continued supplies of that medicinal product to wholesale distributors, pharmacies and persons authorised to supply medicinal products so that the needs of patients in the Member State in question are covered.

Or. en

Amendment 803

Marian-Jean Marinescu

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

The introduction of such an obligation should not lead to a supply system on a first-come, first served basis which would create competitive distortions and create the risk that the Marketing Authorisation Holder would not be able to supply other wholesalers in accordance with their usual orders.

Amendment 804

Maria Angela Danzì

Proposal for a directive

Article 56 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

The arrangements for implementing the first subparagraph should, moreover, be justified on grounds of public health protection and be proportionate in relation to the objective of such protection, in compliance with the Treaty rules, particularly those concerning the free movement of goods and competition.

The arrangements for implementing the first subparagraph should be based on the high level of human health protection in compliance with the Treaty rules.

Or. en

Justification

A clear reference to the Treaty-based high level of human health protection would help in guiding the arrangements for this obligation.

Amendment 805

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 56 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. For SoHO-derived medicinal products, which are obtained from altruistic and unpaid donations, Member States shall ensure, through public service obligations, that manufacturers, within the limits of their responsibilities, provide an appropriate and continuous supply to patients in each Member State.Member States shall negociate fair and transparent prices for SoHO-derived medicinal products and ensure that low-profit products are also available to patients and that there is a continuous investment on research and innovation for those products.

When medicinal products are derived from donated SoHOs, manufacturers must, as for public service obligation in the Member States, report annually to the authorities the amount of processed locally-collected SoHOs and medicinal products prepared from them.

Or. en

Amendment 806

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 56 – paragraph 4

Text proposed by the Commission

Amendment

4. The marketing authorisation holder shall, at all stages of manufacturing and distribution ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.

4. The marketing authorisation holder shall, at all stages of manufacturing and distribution, within the limits of its responsability, ensure that the starting materials and ingredients of the medicinal products and the medicinal products themselves comply with the requirements of this Directive and, where relevant, the [revised Regulation (EC) No 726/2004] and other Union law and shall verify that such requirements are met.

Or. en

Amendment 807

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 56 – paragraph 7

Text proposed by the Commission

Amendment

7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.

7. Where the marketing authorisation holder considers or has reason to believe that the medicinal product it has made available on the market is not in conformity with the marketing authorisation or this Directive and the [revised Regulation (EC) No 726/2004] it shall immediately take the necessary corrective actions to bring that medicinal product into conformity, to withdraw it or recall it, as appropriate, in consultation with the competent authorities. The marketing authorisation holder shall immediately inform the competent authorities and the distributors concerned to that effect.

Or. en

Amendment 808

Joanna Kopcińska, Margarita de la Pisa Carrión, Andrey Slabakov

Proposal for a directive

Article 56 – paragraph 9

Text proposed by the Commission

Amendment

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product, and any data in its possession relating to the volume of prescriptions.

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product in the Union or Member State, and any data in its possession relating to the volume of prescriptions in the Union or Member State. The marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product.

Or. en

Amendment 809

Margarita de la Pisa Carrión

Proposal for a directive

Article 56 – paragraph 9

Text proposed by the Commission

Amendment

Or. en

Amendment 810

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Article 56 – paragraph 9

Text proposed by the Commission

Amendment

9. Upon request the marketing authorisation holder shall provide the competent authority with all data relating to the volume of sales of the medicinal product in the Union or Member State. The Marketing Authorisation Holder could rely on the information contained in the repositories system referred to in Article 67, paragraph 2, second sub-paragraph, point (e) for the provision of data relating to the volume of sales of the medicinal product and any data in its possession relating to the volume of prescriptions.

Or. en

Amendment 811

Heléne Fritzon

Proposal for a directive

Article 56 – paragraph 9 a (new)

Text proposed by the Commission

Amendment

9 a. The marketing authorisation holder shall also be responsible for making the medicinal product available in therapy-appropriate package sizes and provide for comprehensive shelf-life documentation. Requests by the Agency pursuant to Article 22 paragraph 8 shall be complied with by the marketing authorisation holder without delay.

Or. en

Justification

Since supply of therapy-appropriate package sizes and comprehensive shelf-life documentation correspond to environmental policy concerns, being pursued by the revision of pharmaceutical legislation, their enforcement should be supported by implementing sanctions.

Amendment 812

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 57 – title

Text proposed by the Commission

Amendment

Responsibility to report on public financial support

Responsibility to report on public financial support and cost data for all applicable research and development activities of medicinal products

Or. en