Sittings · Document

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

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

Committee on the Environment, Public Health and Food Safety

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Amendment 1492

Dolors Montserrat

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for critical medicinal product placed on the market. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by determining medicinal products for whicvh a shortage prevention plan shall be maintaned and kept up to date, including due to the lack of availability of alternatives. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1493

Dolors Montserrat

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information established in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2. The shortage prevention plan shall be made available to the Agency and the competent authority of the Member State where the medicinal product has been placed on the market.

Or. es

Amendment 1494

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. Within 18 months of the entry into force of the present Regulation, the marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1495

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product included on the Union list of critical medicinal products established by Article 131. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. fr

Amendment 1496

Fulvio Martusciello

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the Union list of critical medicinal products referred to in Article 131. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1497

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the Union list of critical medicinal products mentioned in Article 131 . To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1498

Andreas Glück, Peter Liese

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the Union critical medicinal products list. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Justification

Having shortage prevention plans should generally be good practice, but can only be enforced for a limited number medicinal products. Therefore, a limitation to products on the Union critical medicinal product list is proposed.

Amendment 1499

Margarita de la Pisa Carrión

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product placed on the list of esencial UE medicals. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1500

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for critical and strategic medicinal products placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1501

István Ujhelyi

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any medicinal product as referred in article 127(1) . To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1502

Stelios Kympouropoulos, Peter Liese

Proposal for a regulation

Article 117 – paragraph 1

Text proposed by the Commission

Amendment

1. The marketing authorisation holder as defined in Article 116(1) shall have in place and keep up to date a shortage prevention plan, for any critical medicinal product placed on the market. To put in place the shortage prevention plan, the marketing authorisation holder shall include the minimum set of information set out in Part V of Annex IV and take into account the guidance drawn up by the Agency according to paragraph 2.

Or. en

Amendment 1503

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 117 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Pursuant to Article 173(2), the Commission may adopt implementing acts listing medicinal products not included on the Union list of critical medicinal products for which a shortage prevention plan is required due to a lack of therapeutic alternatives.

Or. fr

Amendment 1504

Tilly Metz

Proposal for a regulation

Article 117 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Shortage prevention plans shall be without delay submitted to the competent authority concerned defined in Article 116(1) and be made publicly available, upon request.

Or. en

Amendment 1505

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 117 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c) and following consultation with health professionals and patient organisations, shall assess the plan and draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

Or. en

Amendment 1506

Tomislav Sokol, Pernille Weiss

Proposal for a regulation

Article 117 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), patients´ organisations and healthcare professionals and other interested parties shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

Or. en

Amendment 1507

Andrey Slabakov

Proposal for a regulation

Article 117 – paragraph 2

Text proposed by the Commission

Amendment

2. Where relevant, the Agency, in collaboration with the working party referred to in Article 121(1), point (c), and other interested parties, shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

Or. en

Amendment 1508

Stelios Kympouropoulos

Proposal for a regulation

Article 117 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency, in collaboration with the working party referred to in Article 121(1), point (c), and other relevant parties, shall draw up guidance to marketing authorisation holders as defined in Article 116(1) to put in place the shortage prevention plan.

Or. en

Amendment 1509

Andreas Glück, Peter Liese

Proposal for a regulation

Article 118 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Based on the reports referred to in Articles 120(1) and 121(1), point (c), information referred to in Articles 119, 120(2) and 121 and the notification made pursuant to Article 116(1), points (a) to (d), the competent authority concerned as referred to in Article 116(1) shall continuously monitor any potential or actual shortage of those medicinal products.

Or. en

Justification

Data on the flow of medicinal products are available at large scale in the European Medicines Verifications System (EMVS). This data should be used as well in order to monitor shortages within the Union.

Amendment 1510

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 118 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. fr

Amendment 1511

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

Proposal for a regulation

Article 118 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1512

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

Proposal for a regulation

Article 118 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. On the basis of the information provided pursuant to article 121(2), point (f), the Agency should monitor and assess any actions foreseen or taken by a Member State to mitigate a shortage at national level with regards to their impact on the availability and supply of medicinal products at European level.

Or. en

(See linked amendment on article 122 (1new))

Amendment 1513

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 118 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. To carry out that monitoring, the Agency shall establish a European medicine stock platform that is continuously updated in real time with data sent by the competent authorities of the Member States, marketing authorisation holders and wholesale distributors.

Or. fr

Amendment 1514

Kateřina Konečná

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may set a deadline for the submission of the information requested.

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3) or the shortage prevention plan referred to in Article 117, where this has not already been requested following paragraph 9 of Article 127. The competent authority concerned shall set a deadline for the submission of the information requested.

Or. en

Amendment 1515

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

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117, where this has not already been requested following paragraph 9 of article 127. The competent authority concerned shall set a deadline for the submission of the information requested.

Or. en

Amendment 1516

Dolors Montserrat

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. 2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit updated versions of the shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may establish a deadline for the submission of the information requested.

Or. es

Justification

The shortage mitigation plan in accordance with Article 119(2), the risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3) and the shortage prevention plan referred to in article 117 shall be in the possession of the competent authorities whether or not the medicinal products are in short supply or at risk of shortage. Therefore, the competent authorities shall request updated versions in order to monitor shortages as necessary.

Amendment 1517

Margarita de la Pisa Carrión

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit updated versions of a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned may set a deadline for the submission of the information requested.

Or. en

Amendment 1518

Tilly Metz

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned shall set a deadline for the submission of the information requested.

Or. en

Amendment 1519

Andrey Slabakov

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned shall set a deadline for the submission of the information requested.

Or. en

Amendment 1520

Maria Angela Danzì

Proposal for a regulation

Article 118 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of paragraph 1, the competent authority concerned as defined in Article 116(1) may request any additional information from the marketing authorisation holder as defined in Article 116(1). In particular, it may request the marketing authorisation holder to submit a shortage mitigation plan in accordance with Article 119(2), a risk assessment of impact of suspension, cessation or withdrawal in accordance with Article 119(3), or the shortage prevention plan referred to in Article 117. The competent authority concerned shall set a deadline for the submission of the information requested.

Or. it

Justification

In the event of shortages of medicinal products, marketing authorisation holders should be given a clear deadline to submit the required information. It is a well-known fact that in the absence of the proposed framework, regulators find it difficult, sometimes impossible, to obtain the information in time.

Amendment 1521

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 119 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(ba) promptly provide information on the stock available and any supply shortages in accordance with Article 130(2), point (da), establishing a European medicine stock platform.

Or. fr

Amendment 1522

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 119 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) issue forecast of demand to provide early-warning of potential critical shortages.

Or. en

Amendment 1523

Tomislav Sokol

Proposal for a regulation

Article 119 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. To comply with their obligations, marketing authorisation holders shall have access to all relevant information contained in the repositories system referred to Article 67, paragraph 2, second subparagraph, point (e) for the purpose of fulfilling any obligation arising under [Revised] Directive (…) or this Regulation, including notifying shortages and assessing whether a product was supplied to another Member State than the one where it was placed.

Or. en

Amendment 1524

Catherine Amalric

Proposal for a regulation

Article 119 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. For the purposes of developing the shortage mitigation plan referred to in Article 118, the marketing authorization holder within the meaning of Article 116(1) shall include the minimum set of information provided for in Annex IV on primary packaging, in order to allow dispensation by unit upon request from the competent authorities of the Member State.

Or. en

Amendment 1525

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 120 – paragraph 1

Text proposed by the Commission

Amendment

1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public may report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State.

Or. en

Amendment 1526

Tiemo Wölken

Proposal for a regulation

Article 120 – paragraph 1

Text proposed by the Commission

Amendment

1. Wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] to the public shall report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority in that Member State.

Or. en

Amendment 1527

Marian-Jean Marinescu

Proposal for a regulation

Article 120 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency, the competent authority in a Member State, and the relevant marketing authorisation holder to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.

Or. en

Justification

A requirement for information to be provided when a shortage is notified to ensure that this shortage was not caused by parallel distribution should be introduced.

Amendment 1528

Tomislav Sokol

Proposal for a regulation

Article 120 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1529

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 120 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When a marketing authorisation holder notifies a temporary disruption in supply of a medicinal product, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products shall provide information requested in a timely manner to the Agency and to the competent authority in a Member State, to confirm that the temporary disruption in supply of the product in a Member State was not caused by parallel distribution to another Member State.

Or. en

Amendment 1530

Cyrus Engerer

Proposal for a regulation

Article 120 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. For the purposes of the reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers designated under article 166(1)(a) of [revised Directive 2001/83/EC] shall transmit the information set out in Part Va of Annex IV to the competent authorities of the Member States in a timely manner.

Or. en

Amendment 1531

Pernille Weiss, Stelios Kympouropoulos

Proposal for a regulation

Article 120 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of Article 118(1), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner.

Or. en

Amendment 1532

Cyrus Engerer

Proposal for a regulation

Article 120 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1533

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

Proposal for a regulation

Article 120 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1534

Tilly Metz

Proposal for a regulation

Article 120 – paragraph 2

Text proposed by the Commission

Amendment

2. For the purposes of Article 118(1), upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner.

Or. en

Amendment 1535

Tilly Metz

Proposal for a regulation

Article 121 – paragraph 1 – point -a (new)

Text proposed by the Commission

Amendment

(-a) collect and assess the information on potential and actual shortages provided by marketing authorisation holders, importers, manufacturers and suppliers of medicinal products or active substances, wholesale distributors, healthcare professionals, patients and consumers and other persons or legal entities that are authorised or entitled to supply medicinal products to the public;

Or. en

Amendment 1536

Tilly Metz

Proposal for a regulation

Article 121 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;

(b) publish and regularly update information on actual shortages of medicinal products, including date when the shortage occurred, expected duration, the reasons as per Article 24(1) and mitigation measures, in cases in which that competent authority has assessed the shortage based on information reported by different stakeholders, on a publicly available website or database interoperable with the European Shortages Monitoring Platform (‘ESMP’), established by Regulation (EU) 2022/123, and ensure such information, including regarding available alternatives, has been proactively communicated to representatives of healthcare professionals and patients;

Or. en

Amendment 1537

Cyrus Engerer

Proposal for a regulation

Article 121 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;

(b) publish information on actual shortages of medicinal products, the reason for the shortage, as well as measures taken to counter the actual shortage, as soon as that competent authority has assessed the shortage and provided clear recommendations and possible alternatives to healthcare professionals and patients, on a publicly available and user-friendly website. The Member State shall, within one week, inform the Agency of any measure foreseen or taken at national level to mitigate the shortage or expected shortage.

Or. en

Amendment 1538

Stelios Kympouropoulos

Proposal for a regulation

Article 121 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;

(b) publish information on actual shortages of medicinal products, as well as measures taken to counter the shortages, as soon as that competent authority has assessed the shortage and provided concrete recommendations, on a publicly available and user-friendly website. The Member State shall, with no undue delay, inform the Agency of any anticipated measures or measures taken at national level to mitigate the shortage.

Or. en

Amendment 1539

Maria Angela Danzì

Proposal for a regulation

Article 121 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;

(b) publish on a publicly available website information on actual shortages of medicinal products, including the known reasons for them, where appropriate in accordance with points (a) to (fa) of the second subparagraph of Article 24(1), in cases in which that competent authority has assessed the shortage and provided recommendations to health-care professionals and patients, including on the alternatives available;

Or. it

Justification

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

Amendment 1540

Kateřina Konečná

Proposal for a regulation

Article 121 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;

(b) publish information on expected or actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available and user- friendly database;

Or. en

Amendment 1541

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 121 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) publish information on actual shortages of medicinal products, in cases in which that competent authority has assessed the shortage, on a publicly available website;

(b) publish information on all notified shortages of medicinal products, as soon as the competent authority has assessed the shortage, on a publicly available website;

Or. en

Amendment 1542

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 121 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) create a system that is user-friendly and straightforward, allowing patients and patient organizations to report shortages of medicinal products.

Or. en

Amendment 1543

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

Proposal for a regulation

Article 121 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) establish an accessible and easily understandable system for patients and patient organisations to report shortages of medicinal products;

Or. en

Amendment 1544

Kateřina Konečná

Proposal for a regulation

Article 121 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) establish an accessible and easily understandable system for patients and patient organisations to report shortages of medicinal products;

Or. en

Justification

The involvement of patients and their representatives in the development of policy solutions is essential, as they are one of the main actors at the end of the supply chain. In particular, they can participate in providing information on alternatives and in reporting shortages to the authorities. Enabling patients to report drug shortages will improve the collection of data and the understanding of their societal impact, thus improving drug shortage management.

Amendment 1545

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 121 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) establish an accessible and easily understandable system for patient organisations to report shortages of medicinal products;

Or. en

Amendment 1546

Margarita de la Pisa Carrión

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) assess information on potential or actual deficiencies provided by marketing authorisation holders authorised to market in a Member State in accordance with Article 5 of [Directive 2001/83/EC as revised] as defined in paragraph 1 of Article 116, importers and manufacturers of medicinal products or active ingredients and relevant suppliers thereof, wholesale distributors, associations representing interested parties or other legal persons or entities which are authorised or authorised to supply medicinal products to the public.

Or. en

Amendment 1547

Dolors Montserrat

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(ca) assess information on potential or actual shortages provided by marketing authorisation holders authorised to place on the market in a Member State in accordance with Article 5 of [revised Directive 2001/83/EC] as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers thereof, wholesale distributors, representative associations of interested parties or other legal persons or entities authorised or entitled to supply medicinal products to the public.

Or. es

Justification

The competent national authorities shall also be responsible for assessing information received directly from marketing authorisation holders and information received from other stakeholders in the supply chain in accordance with Article 120(1).

Amendment 1548

Marian-Jean Marinescu

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medication product request pharmacies supplying hospitals and hospital pharmacies, to communicate electronically data on available stock of the respective medicinal product.

Or. en

Justification

As demonstrated during the COVID-19 crisis, hospitals will be a key stakeholder in the mitigation and management of medicines shortages; they will need to share information on demand and supply of medicinal products in-situ to National Competent Authorities to support manufacturers plan production of medicinal products.

Amendment 1549

István Ujhelyi

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) shall in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medication product request pharmacies supplying hospitals and hospital pharmacies, to communicate electronically data on available stock of the respective medicinal product

Or. en

Amendment 1550

Tiemo Wölken

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) request from pharmacies supplying hospitals and hospital pharmacies, to electronically communicate data on available stock of the respective medicinal product, in order to avert or mitigate an imminent or existing supply shortage relevant to the supply of a medicinal product.

Or. en

Amendment 1551

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(ca) promptly provide information on the stock available and any supply shortages in accordance with Article 130(2), point (da), establishing a European medicine stock platform.

Or. fr

Amendment 1552

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

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) address recommandations to health professionals and patients on the alternative medicinal products to use to pursue treatments;

Or. en

Amendment 1553

Andrey Slabakov

Proposal for a regulation

Article 121 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) consider the use of appropriate regulatory measures to mitigate the shortage.

Or. en

Amendment 1554

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen, Dacian Cioloş

Proposal for a regulation

Article 121 – paragraph 1 – point c b (new)

Text proposed by the Commission

Amendment

(c b) launch information campaign to discourage hoarding or to avoid waste, at any level of the supply chain, from wholesalers to patients.

Or. en

Amendment 1555

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 121 – paragraph 1 – point c b (new)

Text proposed by the Commission

Amendment

(cb) examine the options for regulatory flexibility to alleviate shortages of medicinal products in the event of a health crisis.

Or. fr

Amendment 1556

Andrey Slabakov

Proposal for a regulation

Article 121 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The competent authority of the Member State may recommend to the relevant authority or social security schemes to raise the prices of medicinal products for which they have identified a risk of shortage or of consolidation. The recommendation must be justified in writing, stating the active substance and the dosage forms concerned. Based on the recommendation, the relevant authority or social security schemes can increase the regulated price caps.

Or. en

Amendment 1557

Stelios Kympouropoulos

Proposal for a regulation

Article 121 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. shall request pharmacies supplying hospitals or hospital pharmacies, to communicate electronic data on the availability and stock of the relevant medicinal product, in order to mitigate or avert supply shortage.

Or. en

Amendment 1558

Pernille Weiss

Proposal for a regulation

Article 121 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level.

(f) as soon as possible inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level.

Or. en

Amendment 1559

Frédérique Ries, Susana Solís Pérez, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 121 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) inform the Agency of any actions foreseen or taken by that Member State to mitigate the shortage at national level.

(f) inform the Agency within one week of any actions foreseen or taken by that Member State to mitigate the shortage at national level.

Or. en

Amendment 1560

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

Proposal for a regulation

Article 121 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. After the expansion of the ESMP referred to in article 122 (6) and for the purpose of articles 118 (1), and 121 (2), point (a), competent authorities of the Member States shall set up national IT systems which are interoperable with the ESMP and allow for the automated exchange of information with the ESMP while avoiding duplication of reporting.

Or. en

Amendment 1561

Stelios Kympouropoulos, Pernille Weiss

Proposal for a regulation

Article 121 – paragraph 5 – point d

Text proposed by the Commission

Amendment

(d) inform the Agency of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions.

(d) as soon as possible inform the Agency of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions.

Or. en

Amendment 1562

Frédérique Ries, Susana Solís Pérez, Billy Kelleher

Proposal for a regulation

Article 121 – paragraph 5 – point d

Text proposed by the Commission

Amendment

(d) inform the Agency in a timely manner of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report within one week on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions.

Or. en

Amendment 1563

Cyrus Engerer

Proposal for a regulation

Article 121 – paragraph 5 – point d

Text proposed by the Commission

Amendment

(d) within one week, inform the Agency of any actions foreseen or taken by that Member State in accordance with points (b) and (c) and report on any other actions taken to mitigate or resolve the critical shortage in the Member State, as well as the results of these actions, within one month.

Or. en

Amendment 1564

Tilly Metz

Proposal for a regulation

Article 121 – paragraph 6

Text proposed by the Commission

Amendment

6. The Member States may request that the MSSG provide further recommendations, referred to in Article 123(4).

6. The Member States may request that the MSSG provide further recommendations, referred to in Article 123(4). Where Member States that take an alternative course of action not in line with the recommendations of the MSSG at national level, they shall share the reasons for doing so with the MSSG in a timely manner.

Or. en

Justification

Based on EMA mandate

Amendment 1565

Catherine Amalric, Max Orville, Billy Kelleher, Frédérique Ries

Proposal for a regulation

Article 121 a (new)

Text proposed by the Commission

Amendment

Article121a

National websites on medicines shortages

The website referred to in article 121 paragraph 1(b) shall include at least the following information:

(a) trade name of the medicinal product and international non-proprietary name, for interoperability purposes;

(b) indication;

(d) start and end dates of the shortages;

(e) information for healthcare professionals and patients, including information about therapeutic alternatives available.

Or. en

Amendment 1566

Kateřina Konečná

Proposal for a regulation

Article 121 a (new)

Text proposed by the Commission

Amendment

Article121a

National websites on medicine shortages

The website referred to in paragraph 1(b) shall include at least the following information:

(a) trade name of the medicinal product and international-non-proprietary name;

(b) indication;

(d) start and end dates;

(e) information for healthcare professionals and patients, including information on alternative treatments.

Or. en

Amendment 1567

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

Proposal for a regulation

Article 122 – paragraph 1

Text proposed by the Commission

Amendment

1. For the purposes of Article 118(1), the Agency may request additional information from the competent authority of the Member State, through the working party referred to in Article 121(1), point (c). The Agency may set a deadline for the submission of the information requested.

1. For the purposes of Article 118(1) and 118(1a)(new), the Agency may request additional information from the competent authority of the Member State, through the working party referred to in Article 121(1), point (c). The Agency may set a deadline for the submission of the information requested.

Or. en

Amendment 1568

Andrey Slabakov

Proposal for a regulation

Article 122 – paragraph 1

Text proposed by the Commission

Amendment

1. For the purposes of Article 118(1), the Agency may request additional information from the competent authority of the Member State, through the working party referred to in Article 121(1), point (c). The Agency shall set a deadline for the submission of the information requested.

Or. en

Amendment 1569

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

Proposal for a regulation

Article 122 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. For the purpose of Article 118 (1a) (new) and based on the information provided pursuant to articles 121 (1), point (d), and 121 (2), the Agency shall assess the actions taken or foreseen by a Member State to mitigate a shortage at national level with regards to any potential or actual negative impacts of these actions on the availability and security of supply in another Member State and at European level.

The Agency shall inform the Member State in question of its assessment in a timely manner and the MSSG and the Member States potentially or actually impacted through the single point of contact working party referred to in Article 3(6) of Regulation (EU) 2022/123. The Agency shall also inform the Commission of its assessment.

Or. en

Amendment 1570

Andrey Slabakov

Proposal for a regulation

Article 122 – paragraph 2

Text proposed by the Commission

Amendment

2. On the basis of Article 118(1), the Agency, in collaboration with the working party referred to in Article 121(1), point (c), shall identify the medicinal products for which the shortage cannot be resolved without EU coordination.

2. On the basis of Article 118(1), the Agency, in collaboration with the working party referred to in Article 121(1), point (c), shall identify the the critical and/or other medicinal products for which the shortage cannot be resolved without EU coordination.

Or. en

Amendment 1571

Frédérique Ries

Proposal for a regulation

Article 122 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. For the purpose of identifying the medicinal products for which the shortage cannot be resolved without EU coordination pursuant to paragraph 2, the Agency may consult market authorisation holders and other relevant stakeholders.

Or. en

Amendment 1572

Andrey Slabakov

Proposal for a regulation

Article 122 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall inform the MSSG of the shortages of the medicinal products that have been identified pursuant to paragraph 2.

3. The Agency shall inform the MSSG of the shortages of the critical or strategic medicinal products that have been identified pursuant to paragraph 2.

Or. en

Amendment 1573

Frédérique Ries

Proposal for a regulation

Article 122 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with the working party referred to in Article 121(1), point (c):

Or. en

Amendment 1574

Kateřina Konečná

Proposal for a regulation

Article 122 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with patients’ organisations and the working party referred to in Article 121(1), point (c):

Or. en

Amendment 1575

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 122 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. For the purposes of fulfilling the tasks referred to in Articles 118(1), 123 and 124, the Agency shall ensure the following, in consultation with patients' organisations and the working party referred to in Article 121(1), point (c):

Or. en

Amendment 1576

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 122 – paragraph 4 – point d

Text proposed by the Commission

Amendment

(d) specify the methods for the provision of recommendations referred to in Article 123(4);

(d) specify the methods for the provision of recommendations referred to in Article 123(4), including the introduction of regulatory flexibility;

Or. fr

Amendment 1577

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 122 – paragraph 4 – point d a (new)

Text proposed by the Commission

Amendment

(da) define the tools, working methods and guidelines for the solidarity mechanism referred to in Article 123(3a), in particular any necessary regulatory flexibility allowing for the quick movement of medicinal products between Member States and backed up by appropriate funding.

Or. fr

Amendment 1578

Marian-Jean Marinescu

Proposal for a regulation

Article 122 – paragraph 4 – point e a (new)

Text proposed by the Commission

Amendment

(e a) specify the systems and procedures to ensure the European Shortages Monitoring Platform (ESMP) includes accurate information on available critical medicinal stocks in legal entities that are authorised or entitled to supply medicinal products to the public including pharmacies supplying hospitals and hospital pharmacies.

Or. en

Justification

Member states provide approximations of hospitals estimations, which is not based on accurate data. If this occurs while no systems and processes are in place during a crisis, it would be impossible to properly manage medication shortages during these crisis periods.

Amendment 1579

István Ujhelyi

Proposal for a regulation

Article 122 – paragraph 4 – point e a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1580

Sirpa Pietikäinen

Proposal for a regulation

Article 122 – paragraph 4 – point e a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1581

Stelios Kympouropoulos

Proposal for a regulation

Article 122 – paragraph 4 – point e a (new)

Text proposed by the Commission

Amendment

(e a) suggest specific procedures to include accurate information, at the European Shortages Monitoring Platform (ESMP), on available critical medicinal stocks in legal entities authorised or entitled to supply medicinal products to the public.

Or. en

Amendment 1582

Cyrus Engerer

Proposal for a regulation

Article 122 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Agency shall assess the measures notified by Member States under Articles 121(1), point (b); 121(2), point (f); and 121(5), point (d) in relation to the effects they may have on the availability of medicines in other Member States, and report on this to the Commission.

Or. en

Amendment 1583

Tomislav Sokol

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive [revised Directive 2001/83/EC], without duplication of reporting for marketing authorisation holders and national competent authorities. The ESMP shall be fully digitalised and automated.

Or. en

Amendment 1584

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that data is interoperable between the ESMP, Member States’ IT systems and, where relevant, with other relevant IT systems and databases, without duplication of reporting. Data included in the ESMP shall contain information on the expected duration of the shortages and the mitigation measures to resolve it. The ESMP shall be fully digitalised and automated and shall use artifical intelligence to provide information about trends in demand and supply from existing data.

Or. en

Amendment 1585

Fulvio Martusciello

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of Directive 2023/0132 (COD) , without duplication of reporting for Marketing Authorisation Holders and National Competent Authorities.

Or. en

Amendment 1586

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP to make it a genuine prevention tool by transforming it into a European medicine stock platform that is continuously updated in real time, as provided for in Article 130. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.

Or. fr

Amendment 1587

Margarita de la Pisa Carrión

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases including repositories system information on safety feature without duplication of reporting for marketing authorisation Holder, other actors involved in supply chain and National Competent Authorities

Or. en

Amendment 1588

Tilly Metz

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP and include, among others, information on the duration, reasons and mitigation measures of medicine shortages. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.

Or. en

Amendment 1589

Andrey Slabakov

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 1590

Stelios Kympouropoulos

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 1591

Kateřina Konečná

Proposal for a regulation

Article 122 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 1592

Pernille Weiss

Proposal for a regulation

Article 122 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The Agency shall assess measures notified by competent authorities of the Member States under Article 121 with regard to possible effects on the availability of medicines in other Member States, and shall where relevant report its findings to the Commission.

Or. en

Amendment 1593

Frédérique Ries

Proposal for a regulation

Article 123 – paragraph 1

Text proposed by the Commission

Amendment

1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG shall adopt a list of critical shortages of medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).

1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c) and, where relevant, market authorisation holders and other stakeholders involved in the supply chain, the MSSG shall adopt a list of critical shortages of medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).

Or. en

Amendment 1594

Margarita de la Pisa Carrión

Proposal for a regulation

Article 123 – paragraph 1

Text proposed by the Commission

Amendment

1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c) with MAHs and other actors of the supply chain, the MSSG shall adopt a list of critical shortages of medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).

Or. en

Amendment 1595

Andrey Slabakov

Proposal for a regulation

Article 123 – paragraph 1

Text proposed by the Commission

Amendment

1. Based on the monitoring referred to in Article 118(1), and following consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG shall adopt a list of critical shortages of critical and strategic medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC]and for which co-ordinated Union level action is necessary (‘the list of critical shortages of medicinal products’).

Or. en

Amendment 1596

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 123 – paragraph 2

Text proposed by the Commission

Amendment

2. The MSSG shall review the status of the critical shortage whenever necessary and shall update the list when it considers that a medicinal product needs to be added or that the critical shortage has been resolved based on the report pursuant to Article 122(5). The MSSG may recommend monitoring forecasts of supply and demand for medicinal products for human use in the EU/EEA and monitoring of available stocks in the whole supply chain.

Or. en

Amendment 1597

Catherine Amalric, Max Orville, Billy Kelleher, Andreas Glück, Dacian Cioloş

Proposal for a regulation

Article 123 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

After adopting the list of critical shortages of medicinal products, the MSSG may analyse the vulnerabilities in the supply chain of those medicines.

Or. en

Amendment 1598

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 123 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. In accordance with the methods established in Article 122(4), point d, the MSSG may decide to activate the solidarity mechanism to allow available national surplus stocks to be shared to alleviate critical shortages.

Or. fr

Amendment 1599

Tilly Metz

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

4. The MSSG may provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

4. The MSSG shall provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), an information regarding available alternatives, to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

Or. en

Amendment 1600

Maria Angela Danzì

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

4. The MSSG shall provide recommendations on measures to resolve or to mitigate the critical shortage, as well as on alternatives available, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

Or. it

Justification

The MSSG plays a crucial role in dealing with shortages of medicinal products at EU level and it should issue recommendations as standard procedure. Health-care professionals require information and recommendations. Doctors must be notified of available alternatives to medicinal products that are unavailable.

Amendment 1601

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

4. The MSSG shall provide recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

Or. en

Amendment 1602

Kateřina Konečná

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 1603

Andrey Slabakov

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

4. The MSSG may provide recommendations on measures to resolve or to mitigate the critical shortage of critical or strategic medicinal products, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

Or. en

Amendment 1604

Cyrus Engerer

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

4. The MSSG may provide without any undue delay recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

Or. en

Amendment 1605

Stelios Kympouropoulos

Proposal for a regulation

Article 123 – paragraph 4

Text proposed by the Commission

Amendment

4. The MSSG may provide as soon as possible recommendations on measures to resolve or to mitigate the critical shortage, in accordance with the methods referred to in Article 122(4), point (d), to relevant marketing authorisation holders, the Member States, the Commission, the representatives of healthcare professionals or other entities.

Or. en

Amendment 1606

Catherine Amalric, Max Orville, Billy Kelleher, Frédérique Ries, Erik Poulsen, Andreas Glück, Dacian Cioloş

Proposal for a regulation

Article 123 – paragraph 4 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Member States, within the MSSG, may decide to activate the “Voluntary Solidarity Mechanism for medicines” to

(a) notify a critical shortage of a medicinal product at national level to other Member States and the Commisison,

(b) identify, with the support of the Agency, the availabilities of the medicinal product in other Member States,

(c) organise, with the support of the Agency, meetings with the issuing Member States, the donating part and other relevant parties to discuss operational requirements,

(d) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicines.

Or. en

Amendment 1607

Andrey Slabakov

Proposal for a regulation

Article 124 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The competent authority of the Member State, the Agency and the Commission shall be entitled to restrict parallel distribution of medicinal products following their additions to the list of critical shortages of medicinal products in accordance with Article 123, paragraphs 1 and 2.

Or. en

Amendment 1608

Tomislav Sokol

Proposal for a regulation

Article 124 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Commission shall be entitled to restrict parallel distribution of medicinal products following their additions to the list of critical shortages of medicinal products in accordance with Article 123, paragraphs 1 and 2.

Or. en

Amendment 1609

Tilly Metz

Proposal for a regulation

Article 124 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

For the purposes of this paragraph, the Agency may set a deadline for the submission of the information requested.

For the purposes of this paragraph, the Agency shall set a deadline for the submission of the information requested.

Or. en

Amendment 1610

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 124 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

For the purposes of this paragraph, the Agency may set a deadline for the submission of the information requested.

For the purposes of this paragraph, the Agency shall set a deadline for the submission of the information requested.

Or. en

Amendment 1611

Andrey Slabakov

Proposal for a regulation

Article 124 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

For the purposes of this paragraph, the Agency may set a deadline for the submission of the information requested.

For the purposes of this paragraph, the Agency shall set a deadline for the submission of the information requested.

Or. en

Amendment 1612

Kateřina Konečná

Proposal for a regulation

Article 124 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

For the purposes of this paragraph, the Agency may set a deadline for the submission of the information requested.

For the purposes of this paragraph, the Agency shall set a deadline for the submission of the information requested.

Or. en

Amendment 1613

Andreas Glück, Catherine Amalric

Proposal for a regulation

Article 124 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Agency shall assess actual critical shortages of medicinal products and provide recommendations to healthcare professionals and patients

Or. en

Justification

In cases of a critical shortage, where a substitution with a another available medicinal product is not possible, healthcare professionals require a timely recommendation by the EMA, in order to adapt treatments.

Amendment 1614

Kateřina Konečná

Proposal for a regulation

Article 124 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available and user-friendly database that provides information on expected or actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. The database shall include the information described in article 121a, in addition to the list of Member States affected by each shortage.This webpage shall also provide references to the databases of shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).

Or. en

Amendment 1615

Kateřina Konečná

Proposal for a regulation

Article 124 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients and on critical shortages in the Member States. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and include, to the extent possible, information from other relevant sources and databases identified by the Agency.

Or. en

Amendment 1616

Tomislav Sokol

Proposal for a regulation

Article 124 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1617

Andreas Glück, Catherine Amalric

Proposal for a regulation

Article 124 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and inlcude reference to alternative treatment options or products and appropriate communication that counteracts the hoarding of medicines as a result of the publication.

Or. en

Justification

Recommendations to healthcare professionals in all cases of shortage should be moved to a single paragraph 2a. Public access to shortages is very welcome, but implies the risk of self-fulfilling prophecies which may result in increased hoarding.

Amendment 1618

Tilly Metz

Proposal for a regulation

Article 124 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on actual critical shortages of medicinal products in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the databases of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b) and the ESMP.

Or. en

Amendment 1619

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 124 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency shall establish within its web-portal referred to in Article 104 a publicly available webpage that provides information on all notified critical shortages of medicinal products as soon as the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. This webpage shall also provide references to the lists of actual shortages published by the competent authorities of the Member State pursuant to Article 121(1), point (b).

Or. en

Amendment 1620

Tilly Metz

Proposal for a regulation

Article 124 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The web portal referred to in paragraph 3 shall include at least the following information:

(a) the name and common name of the medicinal product on critical shortage;

(b) the therapeutic indications for the medicinal product on critical shortage;

(d) the start and expected duration of the critical shortage of the medicinal product;

(e) the Member States affected by the critical shortage of the medicinal product;

(f) mitigation measures taken to address the critical shortage of the medicinal product;

(g) other relevant information for healthcare professionals and patients, including information on whether alternative medicinal products are available.

Or. en

Justification

Based on EMA mandate

Amendment 1621

Cyrus Engerer

Proposal for a regulation

Article 124 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Marketing authorisation holders as defined in Article 116(1) and other actors listed in Article 120(2) that are directly affected by the measures notified under Articles 121(1), point (b); 121(2), point (f); and 121(5), point (d) shall be granted access to documents, while protecting commercially confidential information. The Agency may set a deadline within which marketing authorisation holders and other actors may submit their comments.

Or. en

Amendment 1622

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 125 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) provide any additional information that the Agency may request;

(a) provide any additional information that the Agency may request, including regular information on the available stocks of medicines;

Or. en

Amendment 1623

Maria Angela Danzì

Proposal for a regulation

Article 125 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. it

Justification

In the event of shortages of critical medicinal products, marketing authorisation holders shall be given clear recommendations and shall be required to follow them so as to improve the situation. The MSSG plays a crucial role in dealing with shortages of medicinal products at EU level and its recommendations must be put into practice rather than merely taken into account.

Amendment 1624

Cindy Franssen, Tom Vandenkendelaere

Proposal for a regulation

Article 125 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) inform the Agency of the end date of the critical shortage.

(f) inform the Agency of the causes and of the end date of the critical shortage.

Or. en

Amendment 1625

Sirpa Pietikäinen

Proposal for a regulation

Article 125 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) inform the Agency of the end date of the critical shortage.

(f) inform the Agency of the causes and of the end date of the critical shortage.

Or. en

Amendment 1626

Maria Angela Danzì

Proposal for a regulation

Article 125 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) inform the Agency of the end date of the critical shortage.

(f) inform the Agency of the causes and the end date of the critical shortage.

Or. it

Justification

With a view to increasing transparency and avoiding shortages due to economic causes, such as withdrawals from the market, marketing authorisation holders must also report the causes of shortages to the Agency.

Amendment 1627

Andrey Slabakov

Proposal for a regulation

Article 125 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) inform the Agency of the end date of the critical shortage.

(f) inform the Agency of the end date of the critical shortage, without undue delay.

Or. en

Amendment 1628

Alessandra Moretti

Proposal for a regulation

Article 125 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) inform the Agency about the exact causes for the shortage and provide clear clarifications about the responsibilities for this shortage along the entire life cycle of the medicinal product;

Or. en

Amendment 1629

Cyrus Engerer

Proposal for a regulation

Article 126 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall, where it considers it appropriate and necessary:

1. The Commission shall, where it considers it appropriate and necessary to manage shortages and critical shortages:

Or. en

Amendment 1630

Pernille Weiss

Proposal for a regulation

Article 126 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where relevant, the Commission may within the scope of its competences take appropriate measures to address findings of the Agency according to the assessment in Article 122 – paragraph 6 a (new).

Or. en

Amendment 1631

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

Proposal for a regulation

Article 126 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall take the appropriate steps to address any concerns raised by the assessment of the Agency referred to in Article 122 (1a) (new).

Or. en

Amendment 1632

Cyrus Engerer

Proposal for a regulation

Article 126 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall take the appropriate steps to address any concerns raised by the report of the Agency in Article 122(6).

Or. en

Amendment 1633

Andrey Slabakov

Proposal for a regulation

Article 127 – title

Text proposed by the Commission

Amendment

Identification and management of critical medicinal products by the competent authority of the Member State

Identification and management of critical and strategic medicinal products by the competent authority of the Member State

Or. en

Amendment 1634

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 127 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authority of the Member State shall identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).

1. The competent authority of the Member State shall identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a), following a consultation with national health professionals and patients organisations.

Or. en

Amendment 1635

Andrey Slabakov

Proposal for a regulation

Article 127 – paragraph 1

Text proposed by the Commission

Amendment

1. The competent authority of the Member State shall identify critical medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).

1. The competent authority of the Member State shall identify critical and strategic medicinal products in that Member State, using the methodology set out in Article 130(1), point (a).

Or. en

Amendment 1636

Andrey Slabakov

Proposal for a regulation

Article 127 – paragraph 2

Text proposed by the Commission

Amendment

2. The competent authority of the Member State acting through the working party referred to in Article 121(1), point (c), shall report to the Agency the critical medicinal products in that Member State identified pursuant to the paragraph 1, as well as the information received from the marketing authorisation holder as defined in Article 116(1).

2. The competent authority of the Member State acting through the working party referred to in Article 121(1), point (c), shall report to the Agency the critical and strategic medicinal products in that Member State identified pursuant to the paragraph 1, as well as the information received from the marketing authorisation holder as defined in Article 116(1).

Or. en

Amendment 1637

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 127 – paragraph 3

Text proposed by the Commission

Amendment

3. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information including the shortage prevention plan referred to in Article 117 from the marketing authorisation holder as defined in Article 116(1).

3. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information including the shortage prevention plan referred to in Article 117 and information on the available stocks of medicines from the marketing authorisation holder as defined in Article 116(1).

Or. en

Amendment 1638

Andrey Slabakov

Proposal for a regulation

Article 127 – paragraph 3

Text proposed by the Commission

Amendment

3. For the purposes of the identification of critical and medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information on a product-by-product basis from the marketing authorisation holder as defined in Article 116(1).

Or. en

Amendment 1639

Andrey Slabakov

Proposal for a regulation

Article 127 – paragraph 4

Text proposed by the Commission

Amendment

4. For the purposes of the identification of critical medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information from other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public.

4. For the purposes of the identification of critical and strategic medicinal products referred to in paragraph 1, the competent authority of the Member State may request relevant information from other entities including other marketing authorisation holders, importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public.

Or. en

Amendment 1640

Kateřina Konečná

Proposal for a regulation

Article 127 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. Once the competent authority has identified the critical medicinal products, it shall request the corresponding marketing authorisation holders to submit the shortage prevention plan for each product, providing it has not been already requested following paragraph 3. Where necessary, the competent authority shall provide binding and other recommendations on measures to reinforce the prevention plan. Such recommendations may be issued through the MSSG following the procedure described in paragraph 1 of Article 132. The competent authority may request at any time the prevention plans of non-critical medicinal products and shall issue binding or other recommendations where necessary. The competent authority shall set a deadline for the submission by marketing authorisation holders of the requested information.

Or. en

Amendment 1641

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 128 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(ea) manage and replenish the European reserve of medicines of health and strategic importance (MISSs) established in Article 134(2).

Or. fr

Amendment 1642

Tiemo Wölken

Proposal for a regulation

Article 128 – paragraph 2

Text proposed by the Commission

Amendment

2. The marketing authorisation as defined in Article 116(1) authorisation shall be responsible for providing correct, not misleading, and complete information as requested by the competent authority concerned as defined in Article 116(1) and shall have the duty to cooperate and to disclose on their own motion any relevant information without undue delay to that competent authority and to update the information as soon as that information becomes available.

2. The marketing authorisation holder as defined in Article 116(1) shall be responsible for providing correct, not misleading, and complete information as requested by the competent authority concerned as defined in Article 116(1) and shall have the duty to cooperate and to disclose on their own motion any relevant information without undue delay to that competent authority and to update the information as soon as that information becomes available.

Or. en

Amendment 1643

Maria Angela Danzì

Proposal for a regulation

Article 128 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The marketing authorisation referred to in Article 116(1) shall also entail the obligation to establish and maintain minimum safety stocks of critical medicinal products set out in Article 131.The minimum safety stocks of critical medicinal products shall be sufficient to cover demand for them for a period of two months in the Member States in which the medicinal product is marketed.

The marketing authorisation holder may apply to the relevant authority for an exemption from maintaining minimum safety stocks on the following grounds:

(a) the manufacturing process or shelf life of the critical medicinal product is incompatible with the duration of the minimum safety stock;

(b) other valid reasons agreed with the relevant authority.

Or. it

Justification

Following the good example of some Member States, it is recommended that an obligation be introduced for marketing authorisation holders to establish and maintain sufficient safety stocks of the finished medicinal product to meet demand for two months in a Member State. The obligation should apply to the critical medicinal products selected pursuant to this Regulation.

Amendment 1644

Tilly Metz

Proposal for a regulation

Article 128 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The marketing authorisation holder shall set up and maintain a minimum safety stock of critical medicinal products which shall be sufficient to cover two months demand of all Member States where the product has been placed on the market.

Or. en

Amendment 1645

Tilly Metz

Proposal for a regulation

Article 128 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. By derogation from paragraph 2a, national competent authorities may, in duly justified cases, grant an exemption from stockpiling obligations to the marketing authorisation holder, upon request, or adopt other complementary measures on the safety of stocks.

Or. en

Amendment 1646

Cyrus Engerer

Proposal for a regulation

Article 129 – paragraph 1

Text proposed by the Commission

Amendment

For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public shall provide any information requested in a timely manner.

Or. en

Amendment 1647

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

Proposal for a regulation

Article 129 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1648

Tilly Metz

Proposal for a regulation

Article 129 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

Language aligned with EMA mandate

Amendment 1649

István Ujhelyi

Proposal for a regulation

Article 129 – paragraph 1

Text proposed by the Commission

Amendment

For the purposes of Article 127(4) and Article 130(2), point (c), and Article 130(4), point (c), where relevant, upon request from the competent authority concerned as defined in Article 116(1), entities including other marketing authorisation holders as defined in Article 116(1), importers and manufacturers of medicinal products or active substances and relevant suppliers of these, wholesale distributors, stakeholder representative associations or other persons or legal entities that are authorised or entitled to supply medicinal products to the public, including hospitals and ambulatory care settings, shall provide any information requested in a timely manner.

Or. en

Amendment 1650

Tomislav Sokol

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), patients’ organisations, healthcare professionals and marketing authorisation holders ensure the following:

Or. en

Amendment 1651

Fulvio Martusciello

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and marketing authorisation holders, ensure the following:

Or. en

Amendment 1652

Margarita de la Pisa Carrión

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c) and marketing authorisation holders, ensure the following:

Or. en

Amendment 1653

Kateřina Konečná

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

The Agency shall, in collaboration with patients’ organisations and the working party referred to in Article 121(1), point (c), ensure the following:

Or. en

Amendment 1654

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

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

The Agency shall, in collaboration with patient organisations and the working party referred to in Article 121(1), point (c), ensure the following:

Or. en

Amendment 1655

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Agency shall, in collaboration with the working party referred to in Article 121(1), point (c), ensure the following:

The Agency shall, in collaboration with patient organisations and the working party referred to in Article 121(1), point (c), ensure the following:

Or. en

Amendment 1656

Andrey Slabakov, Elisabetta De Blasis

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;

(a) develop a common methodology to identify critical medicinal products, including the evaluation of the therapeutic indication and importance, the availability of appropriate alternatives, and vulnerabilities with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;

Or. en

Amendment 1657

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, prioritising medicines of health and strategic importance (MISSs) and in consultation, where appropriate, with relevant stakeholders;

Or. fr

Amendment 1658

Tilly Metz

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1659

Tomislav Sokol

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;

Or. en

Amendment 1660

Fulvio Martusciello

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1661

Frédérique Ries

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and available alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;

Or. en

Amendment 1662

Maria Angela Danzì

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities with respect to the supply chain of those medicines, where appropriate, with relevant stakeholders;

Or. it

Justification

The involvement of HCPs and other stakeholders in the development of a common methodology to identify critical medicines cannot be optional. The methodology should be transparent and developed in a collaborative manner.

Amendment 1663

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(da) establish a European medicine stock platform that is continuously updated in real time with data sent by the competent authorities of the Member States, industrial actors and wholesale distributors.

Or. fr

Amendment 1664

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point d b (new)

Text proposed by the Commission

Amendment

(db) develop, with the Member States, innovative and coordinated strategies and step up exchanges of good practice in the area of stock management.

Or. fr

Amendment 1665

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 1 – point d c (new)

Text proposed by the Commission

Amendment

(dc) coordinate, with marketing authorisation holders, the management of the European reserve of medicines of health and strategic importance (MISSs) established in Article 134(2).

Or. fr

Amendment 1666

Maria Angela Danzì

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency shall publish the information referred to in points (b), (c) and (d) on a dedicated webpage on its web-portal.

The Agency shall publish the information referred to in points da(a) to (d) on a dedicated webpage on its web-portal.

Or. it

Justification

The methodology used to identify critical medicinal products (Article 130(1)(a)) shall be published on the Agency's web-portal. The critical medicines must be selected in a transparent manner and the relevant stakeholders must be involved in the decision-making process.

Amendment 1667

Tilly Metz

Proposal for a regulation

Article 130 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency shall publish the information referred to in points (b), (c) and (d) on a dedicated webpage on its web-portal.

The Agency shall publish the information referred to in paragraph 1 on a dedicated webpage on its web-portal.

Or. en

Amendment 1668

Tilly Metz

Proposal for a regulation

Article 130 – paragraph 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) the marketing authorisation holder of the medicinal product, including the shortage prevention plan, referred to in Article 117;

(b) the marketing authorisation holder of the medicinal product, including the shortage prevention and mitigation plan, referred to in Article 117 and 119(2);

Or. en

Amendment 1669

Catherine Amalric, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 130 – paragraph 5

Text proposed by the Commission

Amendment

5. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency shall report to the MSSG on any relevant information received from the marketing authorisation holder pursuant to Article 133 and the competent authority of the Member State in accordance with Article 127, paragraphs 7 and 8.

5. Following the adoption of the Union list of critical medicinal products in accordance with Article 131, the Agency shall assess and report to the MSSG on any relevant information received from the marketing authorisation holder pursuant to Article 133 and the competent authority of the Member State in accordance with Article 127, paragraphs 7 and 8.

Or. en

Amendment 1670

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

Proposal for a regulation

Article 130 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. Following the request by a Member State to launch the Voluntary Solidarity Mechanism referred to in article 132(5), the Agency shall provide assistance to the MSSG and may:

(a) confirm that the conditions are met to launch the Voluntary Solidarity Mechanism;

(b) notify the members of the MSSG of the launch of the Voluntary Solidarity Mechanism;

(d) put the issuing country in contact with those Member States able to support them;

(e) organise meetings with the issuing Member States, the donating party and other relevant concerned parties;

(f) request the activation of the Union Civil Protection Mechanism to coordinate and logistically support the voluntary transfer of medicines.

Or. en

Amendment 1671

Andrey Slabakov

Proposal for a regulation

Article 131 – title

Text proposed by the Commission

Amendment

The Union List of Critical Medicinal Products

The Union List of Critical and Strategic Medicinal Products

Or. en

Amendment 1672

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC], prioritising medicines of health and strategic importance (MISSs) and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

The Union list of critical medicinal products shall be drawn up in coordination with the lists established and communicated by the Member States.

Or. fr

Amendment 1673

Dolors Montserrat

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1674

Andrey Slabakov

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1675

Tomislav Sokol

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) in addition to marketing authorisation holders, patients´ organisations and other relevant stakeholders. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Or. en

Amendment 1676

Fulvio Martusciello

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c), in addition to marketing authorisation holders and other relevant stakeholders. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Or. en

Amendment 1677

Tilly Metz

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) as well as representatives of patients, consumers and healthcare professionals. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Or. en

Amendment 1678

Margarita de la Pisa Carrión

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) also markreting authorisation holders, national agencys and other actors. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Or. en

Amendment 1679

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c) and health professionals and patients organisations. Based on this consultation, the MSSG shall propose a Union list of critical medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Or. en

Amendment 1680

Andrey Slabakov

Proposal for a regulation

Article 131 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the reporting referred to in Article 130, paragraph 2, second subparagraph, and Article 130(5), the MSSG shall consult the working party referred to in Article 121(1), point (c). Based on this consultation, the MSSG shall propose a Union list of critical and strategic medicinal products authorised to be placed on the market of a Member State pursuant to Article 5 of [revised Directive 2001/83/EC] and for which coordinated Union level action is necessary (“the Union list of critical medicinal products”).

Or. en

Amendment 1681

Kateřina Konečná

Proposal for a regulation

Article 131 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Agency shall establish a consultation process with patients and consumers in relation to the procedure for establishing the Union list of critical medicines.

Or. en

Amendment 1682

Tomislav Sokol

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers and inventory management.

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c) in addition to marketing authorisation holders, patients’ organisations and other relevant stakeholders, the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures or recommendations on should be justified and risk-based, targeted and proportionate to the identified, underlying root causes of the supply security risk and patient impact and may include diversification of suppliers.

Or. en

Amendment 1683

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on increase of manufacturing capacity, reorganisation of manufacturing capacity, diversification of suppliers, inventory management, establishment of minimum safety stock and if necessary, redistribution of available stock among Member States to address urgent needs.

Or. en

Amendment 1684

Kateřina Konečná

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG shall request marketing authorisation holders to submit to the Agency, by a specific deadline, the prevention plans of those medicinal products. The MSSG shall, where necessary, provide binding or other recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Such measures may include recommendations on diversification of suppliers and inventory management.

Or. en

Amendment 1685

Fulvio Martusciello

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c) in addition to marketing authorisation holders and other relevant stakeholders, the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Any measures or recommendations should be justified and risk-based, targeted and proportionate to the identified, underlying root causes of the supply security risk and patient impact.

Or. en

Amendment 1686

Margarita de la Pisa Carrión

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), with the marketing autorisation holders and other actors, the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. measures or recommendations on diversification of suppliers and inventory management that ate justified and well balance, facing root causes of the supply risk and patients

Or. en

Amendment 1687

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

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1688

Andrey Slabakov

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1689

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

Or. fr

Amendment 1690

István Ujhelyi

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities. Any measures or recommendations should be justified and risk-based, targeted and proportionate to the identified, underlying root causes of the supply security risk and patient impact.

Or. en

Amendment 1691

Susana Solís Pérez

Proposal for a regulation

Article 132 – paragraph 1

Text proposed by the Commission

Amendment

1. Following the adoption of the Union list of critical medicinal products pursuant to Article 131(3), in consultation with the Agency and the working party referred to in Article 121(1), point (c), the MSSG may provide recommendations, in accordance with the methods referred to in Article 130(1), point (d), on appropriate security of supply measures to marketing authorisation holders as defined in Article 116(1), the Member States, the Commission or other entities.

Or. en

Amendment 1692

Frédérique Ries

Proposal for a regulation

Article 132 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Any recommandations provided pursuant to paragraph 1 should be justified and risk-based, targeted and proportionate.

Or. en

Amendment 1693

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

Proposal for a regulation

Article 132 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. The MSSG shall set up a Voluntary Solidarity Mechanism to allow Member States to request assistance in obtaining stocks of a medicine during critical shortages. The MSSG shall specify the procedures and criteria to launch the Voluntary Solidarity Mechanism in consultation with the Member States, the Agency and the Commission.

Or. en

Amendment 1694

Frédérique Ries

Proposal for a regulation

Article 132 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1 c. Following the adoption or update of the Union list of critical medicinal products, the MSSG shall assess the shortage prevention plan of the medicinal products present on the list.

Or. en

Amendment 1695

Maria Angela Danzì

Proposal for a regulation

Article 133 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. it

Justification

Holders of marketing authorisations for critical medicinal products shall be given clear recommendations and shall be required to follow them so as to improve security of supply. The MSSG plays a crucial role in dealing with shortages of medicinal products at EU level and its recommendations must be taken into account.

Amendment 1696

Kateřina Konečná

Proposal for a regulation

Article 133 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) maintain contingency stocks of finished medicinal products included in the list referred to in Article 131. Contingency stocks shall be sufficient to meet at least a two-month demand of the medicinal product in each Member State where it has been placed on the market. This obligation shall not preclude the possibility of Member States to adopt complementary measures on safety stocks based on their own lists of medicines considered of major interest.

Or. en

Amendment 1697

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 133 a (new)

Text proposed by the Commission

Amendment

Article 133a

Creation of non-profit pharmaceutical undertakings

1. To alleviate critical shortages of medicines of health and strategic interest (MISS) in emergencies or where they are no longer profitable for pharmaceutical companies, and in the absence of existing industrial production, the European Commission is empowered to adopt delegated acts in accordance with Article 175, establishing one or more non-profit European pharmaceutical undertakings capable of producing these medicinal products.

2. With a view to creating the undertakings referred to in paragraph 1, the Commission shall:

(a) call on the MSSG to provide an analysis of the market failures that these undertakings need to cover;

(b) call on industrial actors to justify in writing the reasons for the systemic nature of these critical shortages;

Or. fr

Amendment 1698

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission may, where it considers it appropriate and necessary:

1. The Commission shall:

Or. fr

Amendment 1699

Tilly Metz

Proposal for a regulation

Article 134 – paragraph 1 – point -a (new)

Text proposed by the Commission

Amendment

(-a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating critical shortages of medicinal products;

Or. en

Justification

Based on EMA mandate

Amendment 1700

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) take into account the MSSG recommendations and implement the relevant measures;

(Does not affect the English version.)

Or. fr

Amendment 1701

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) inform the MSSG of those measures taken by the Commission.

(b) inform the MSSG and the Member State authorities of those measures taken by the Commission.

Or. fr

Amendment 1702

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(Does not affect the English version.)

Or. fr

Amendment 1703

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(ca) develop guidelines to ensure that national initiatives on stockpiling are proportionate to the needs and do not create undesirable consequences, such as supply shortages, in other Member States;

Or. fr

Amendment 1704

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 134 – paragraph 1 – point c b (new)

Text proposed by the Commission

Amendment

(cb) develop, within the framework of the Public Procurement Directive 2014/24/EU1 c, guidelines to support sustainable public procurement practices in the pharmaceutical field, in particular with regard to the implementation of the most economically advantageous tender (MEAT) criteria in order to establish remedies against single-winner, price-only tenders.

_________________

1 c Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94 28.3.2014, p. 65).

Or. fr

Amendment 1705

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

Proposal for a regulation

Article 134 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Commission shall also work with the European Centre for Disease prevention and Control on building reliable forecasts of potentiel threats and potential shortages.

Or. en

Amendment 1706

Marian-Jean Marinescu

Proposal for a regulation

Article 134 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decide to adopt an implementing act to improve security of supply. The implementing act may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, shall adopt an implementing act to improve security of supply. The implementing act may impose contingency stock requirements of active pharmaceutical ingredient or finished dosage forms, or other relevant measures required to improve security of supply, on marketing authorisation holders, wholesale distributors or other relevant entities.

Or. en

Justification

improving the security of medicines supply