Changes from plenary report to adopted text

Added(ze) cooperating with EU decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards the scientific assessment of relevant substances, exchange of data and information and development of coherent scientific methodologies, including replacing, reducing or refining animal testing, and, where possible, prioritising replacement strategies such as non-animal in vitro and silico approaches, taking into account the specificities of the assessment of medicinal products; [Am. 311]

Added(zf) coordinating the monitoring and management of critical shortages of medicinal products included in the list referred to in Article 123(1);

Added(zg) coordinating the identification and management of the Union list of critical medicinal products referred to in Article 131;

Added(zh) supporting the working party referred to in Article 121(1), point (c), and the MSSG in their tasks in relation to critical shortages and critical medicines;

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

Added(zj) facilitating joint non-clinical studies between applicants and holders to avoid unnecessary duplication of tests using live animals;

Added(zk) facilitating data sharing of results from non-clinical studies on live animals;

Added(zl) drawing up scientific guidelines to facilitate the implementation of the definitions established in this Regulation and in [revised Directive 2001/83], and for the environmental risk assessment of medicinal products for human use, in consultation with the Commission and the Member States.

Added(zla) where scientific guidelines are provided, the Agency shall ensure that such guidelines are kept up-to-date and based on the latest scientific developments. [Am. 312]

Added2. The database provided for in paragraph 1, point (n), shall include all medicinal products for human use authorised in the Union together with the summaries of product characteristics, European product assessment reports, periodic safety update reports, where applicable documentation related to scientific advice received, environmental risk assessment reports, the package leaflet and, the information shown on the labelling, awareness cards in the case of antimicrobials, post-marketing obligations related to the medicinal product, shortage prevention and, where relevant, mitigation plans, and information as to in which Member States the medicinal product is placed on the market and other documents deemed relevant by the Agency. Where relevant, it shall include the electronic links to the dedicated webpages where the marketing authorisation holders have reported the information pursuant to Article 40(4), point (b), and Article 57 of [revised Directive 2001/83/EC]. [Am. 313]

AddedFor the purposes of the database, the Agency shall set up and maintain a list of all medicinal products for human use authorised in the Union. To this effect:

Added(a) the Agency shall make public a format for the electronic submission of information on medicinal products for human use;

Added(b) marketing authorisation holders shall electronically submit to the Agency information on all medicinal products for human use authorised in the Union and shall inform the Agency of any new or varied marketing authorisations granted in the Union, using the format referred to in point (a).

Added(ba) marketing authorisation holders shall electronically submit to the Agency information concerning in which Member States the medical products for human use authorised in the Union have been placed on the market. [Am. 314]

AddedWhere appropriateapplicable, the database shall also include references to clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 81 of Regulation (EU) No 536/2014. [Am. 315]

AddedArticle 139 Coherence of scientific opinions with other Union bodies

Added1. The Agency shall take the necessary and appropriate measures to monitor and identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other Union bodies and agencies carrying out similar tasks in relation to issues of common concern.

Added2. Where the Agency identifies a potential source of divergence, it shall contact the body or agency in question to ensure that all relevant scientific or technical information is shared and in order to identify potentially contentious scientific or technical issues.

Added3. Where a substantive divergence over scientific or technical issues is identified and the body concerned is a Union Agency or a scientific committee, the Agency and the body concerned shall cooperate to resolve the divergence, and inform the Commission without undue delay.

Added4. The Commission may ask the Agency to conduct an assessment as regards specifically the use of the substance concerned in medicinal products. The Agency shall make public its assessment stating clearly the reasons for its specific scientific conclusions.

Added5. To enable coherence between scientific opinions and to avoid duplication of tests, the Agency shall make arrangements with other bodies or agencies established under Union law for cooperation on scientific assessments and methodologies. The Agency shall also make arrangements for the exchange of data and information on relevant substances with the Commission, Member States’ authorities and other Union Agencies, in particular for environmental risk assessments, non-clinical studies and maximum residue limits.

AddedThese arrangements shall seek to ensure that exchanges of data and information are made available in electronic formats and shall protect the commercially confidential nature of the information exchanged and be without prejudice to the provisions on regulatory protection.

AddedArticle 140 Scientific opinions in the context of international collaboration

Added1. The Agency may give a scientific opinion, in particular in the context of cooperation with the World Health Organization, for the evaluation of certain medicinal products for human use intended for markets outside the Union. For this purpose, an application shall be submitted to the Agency in accordance with the provisions of Article 6. Such application may be submitted and assessed together with a marketing authorisation application or any subsequent variation for the EU. The Agency may, after consulting the World Health Organization, and as appropriate other relevant organisations, draw up a scientific opinion in accordance with Articles 6, 10 and 12. The provisions of Article 13 shall not apply.

Added2. The Agency shall establish specific procedural rules for the implementation of paragraph 1, as well as for the provision of scientific advice.

AddedArticle 141 International regulatory cooperation

Added1. In so far as is necessary in order to achieve the objectives set out in this Regulation, and without prejudice to the respective competences of the Member States and the institutions of the Union, the Agency may cooperate with the competent authorities of third countries and/or with international organisations.

AddedTo this end, the Agency may, subject to prior approval by the Commission, establish working arrangements with the authorities of third countries and international organisations, with regard to:

Added(a) the exchange of information, including non-public information, where relevant jointly with the Commission;

Added(b) sharing of scientific resources and expertise, with a view to facilitating collaboration, while maintaining independent assessment in full compliance with the provisions of this Regulation and [revised Directive 2001/83/EC] and under conditions determined beforehand by the Management Board, in agreement with the Commission;

Added(c) the participation in certain aspects of the Agency's work, under conditions determined beforehand by the Management Board, in agreement with the Commission.

AddedThese arrangements shall not create legal obligations incumbent on the Union and its Member States.

Added2. The Agency shall ensure that it is not seen as representing the Union position to an outside audience or as committing the Union to international cooperation.

Added3. The Commission may, in agreement with the Management Board and the relevant committee, invite representatives of international organisations with an interest in the harmonisation of technical requirements applicable to medicinal products for human use and to veterinary medicinal products to participate as observers in the work of the Agency. The conditions for participation shall be determined in advance by the Commission.

AddedSection 2 Structure and operation

AddedArticle 142 Administrative and management structure

AddedThe Agency shall comprise:

Added(a) a Management Board, which shall exercise the functions set out in Articles 143, 144 and 154.

Added(b) an Executive Director, who shall exercise the responsibilities set out in Article 145;

Added(c) a Deputy Executive Director who shall exercise the responsibilities set out in Article 145(7);

Added(d) the Committee for Medicinal Products for Human Use;

Added(e) the Pharmacovigilance Risk Assessment Committee;

Added(f) the Committee for Veterinary Medicinal Products set up pursuant to Article 139(1) of Regulation (EU) 2019/6;

Added(g) the Herbal Medicinal Products working group set up pursuant to Article 141 of [revised Directive 2001/83/EC];

Added(h) the Emergency task force set up pursuant to Article 15 of Regulation (EU) 2022/123;

Added(i) the MSSG set up pursuant to Article 3 of Regulation (EU) 2022/123;

Added(j) the Medical Device Shortages Steering Group, set up pursuant to Article 21 of Regulation (EU) 2022/123;

Added(k) the inspection working group;

Added(l) a Secretariat, which shall provide technical, scientific and administrative support to all bodies of the Agency and ensure appropriate coordination between them, and which shall provide technical and administrative support for the coordination group referred to in Article 37 of [revised Directive 2001/83/EC] and ensure appropriate coordination between it and the Committees. It shall also ensure the implementation of all transparency commitments and undertake the work required of the Agency under the procedures for the assessment and preparations of decisions for paediatric investigation plans, waivers, deferrals or orphan designations. [Am. 316]

AddedArticle 143 Management Board

Added1. The Management Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights.

AddedIn addition, two representatives of patients' organisations, one representative of doctors' organisations, one representative of pharmacists’ organisations and one representative of veterinarians' organisations, all with voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board. [Am. 317]

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

Added2. Members of the Management Board and their alternates shall be appointed on the basis of their knowledge, recognised experience and commitment in the field of medicinal products for human or veterinary use, taking into account relevant managerial, administrative and budgetary expertise [which are to be used to further the objectives of this Regulation].

AddedAll parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a gender balanced representation between men and women on the Management Board. [Am. 318]

Added3. Each Member State and the Commission shall appoint their members of the Management Board as well as an alternate who will replace the member in their absence and vote on their behalf.

Added4. The term of office for members and their alternates shall be four years. That term shall be extendable once consecutively. [Am. 319]

Added4a. Representatives from patients' organisations serving as members or alternate members on scientific committees shall be eligible for reimbursement of expenses incurred in the execution of their duties as representatives, financed through the Agency budget, in accordance with the financial rules applicable to the Agency. [Am. 320]

Added5. The Management Board shall elect a chairperson and a Deputy chairperson from among its members.

AddedThe chairperson and the Deputy chairperson shall be elected by a majority of two-thirds of the members of the Management Board with voting rights.