Changes from plenary report to adopted text

Added(b) provide additional relevant information to the Agency;

Added(c) take into account the recommendations referred to in Article 132(1);

Added(d) comply with any measures taken by the Commission in accordance with Article 134(1), point (a), or by the Member State pursuant to Article 127(7), point (e);

Added(e) inform the Agency of any measures taken and report on the results of such measures.

AddedArticle 134 Role of the Commission

Added1. The Commission may, where it considers it appropriate and necessaryshall: [Am. 296]

Added(-a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating critical shortages of medicinal products; [Am. 297]

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

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

Added(c) request the MSSG to provide information or an opinion or further recommendations referred to in Article 132(1).

Added(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; [Am. 298]

Added(cb) develop, within the framework of Directive 2014/24/EU, guidelines to support 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. [Am. 299]

Added1a. The Commission shall work with the ECDC on producing reliable forecasts of potential threats and potential shortages. [Am. 300]

Added2. The Commission, taking into consideration the information or the opinion, referred to in paragraph 1, or MSSG recommendations, may decideis empowered to adopt an implementing actdelegated acts in accordance with Article 175 supplementing this Regulation to improve security of supply, while allowing Member States to adopt or maintain legislation ensuring a higher degree of protection against shortages of medicinal products, in respect of the commitments taken in the framework of the Voluntary Solidarity Mechanism. The delegated acts. 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. [Am. 301]

Added3. The implementing act referred to in paragraph 2 shall be adopted in accordance with the examination procedure referred to in Article 173(2). [Am. 302]

AddedCHAPTER XI EUROPEAN MEDICINES AGENCY

AddedSection 1 Tasks of the Agency

AddedArticle 135 Establishment

AddedThe functioning of the European Medicines Agency established by Regulation (EC) No 726/2004 (the ‘Agency’) shall continue in accordance with the present Regulation.

AddedThe Agency shall be responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products for human use and of veterinary medicinal products.

AddedArticle 136 Legal status

Added1. The Agency shall have legal personality.

Added2. In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property, and be party to legal proceedings.

Added3. The Agency shall be represented by an Executive Director.

AddedArticle 137 Seat

AddedThe seat of the Agency shall be established in Amsterdam, the Netherlands.

AddedArticle 138 Objectives and tasks of the Agency

Added1. The Agency shall provide the Member States and the institutions of the Union with the best possible scientific opinion on any question relating to the evaluation of the quality, safety and, efficacy and environmental risk of medicinal products for human use, veterinary medicinal products, which is referred to it in accordance with the Union legal acts relating to medicinal products for human use or veterinary medicinal products. [Am. 303]

AddedThe Agency, acting particularly through its Committees and working groups, shall carry out the following tasks: [Am. 304]

Added(a) coordinating the scientific evaluation of the quality, safety and, efficacy and environmental risk of medicinal products for human use, which are subject to Union marketing authorisation procedures; [Am. 305]

Added(aa) develop, after consulting with relevant national authorities and national bodies responsible for pricing and reimbursement in accordance with Article 162 of this Regulation and the Member State Coordination Group on Health Technology Assessment established by Article 3 of Regulation (EU) 2021/2282, harmonised standards for the design of scientific studies for marketing authorisation holders; [Am. 306]

Added(b) coordinating the scientific evaluation of the quality, safety and efficacy of veterinary medicinal products, which are subject to Union marketing authorisation procedures in accordance with Regulation (EU) 2019/6, providing advice on methodological aspects relating to the trials for such products and the use of clinical trial results affected for regulatory purposes and coordinating and the performance of other tasks set out in Regulation (EU) 2019/6 and Regulation (EC) 470/2009; [Am. 307]

Added(c) transmitting on request and making publicly available assessment reports, summaries of product characteristics, periodic safety update reports, labels and, package leaflets and AMR awareness cards, where applicable, for the medicinal products for human use; [Am. 308]

Added(d) coordinating the monitoring of medicinal products for human use which have been authorised in the Union and providing advice on the measures necessary to ensure the safe and effective use of those products, in particular by coordinating the evaluation and implementation of pharmacovigilance obligations and systems and the monitoring of such implementation;

Added(e) ensuring the collation and dissemination of information on suspected adverse reactions to medicinal products for human use authorised in the Union by means of databases that are permanently accessible to all Member States;

Added(f) assisting Member States with the rapid communication of information on pharmacovigilance concerns relating to medicinal products for human use to healthcare professionals and coordinating the safety announcements of the competent authorities of the Member States;

Added(g) distributing appropriate information on pharmacovigilance concerns relating to medicinal products for human use to the general public, in particular by setting up and maintaining a European medicines web-portal;

Added(h) coordinating, as regards medicinal products for human use and veterinary medicinal products, the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice, good pharmacovigilance practice and, as regards medicinal products for human use, the verification of compliance with pharmacovigilance obligations;

Added(i) ensuring the secretariat of the Joint Audit Programme referred to in Article 54;

Added(j) upon request, providing technical and scientific support in order to improve cooperation between the Union, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation and monitoring of medicinal products for human use and of veterinary medicinal products, in particular in the framework of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the Veterinary International Conference on Harmonization;

Added(k) coordinating as referred to in Article 53 a structured cooperation on inspections in third countries between Member States, the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe, the World Health Organization or trusted international authorities, by means of international inspection programmes;

Added(l) conducting inspections with Member States to verify the compliance with the principles of good manufacturing practice, including issuing GMP certificates and good clinical practice at the request of the Supervisory Authority referred to in Article 50(2) whenever additional capacity is needed to carry out inspection of Union interest including in response of public health emergencies;

Added(m) recording the status of marketing authorisations for medicinal products for human use granted in accordance with Union marketing authorisation procedures;

Added(n) creating a user-friendly database on medicinal products for human use, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database is to facilitate the search for information already authorised for package leafletsleaflet, and for other documents deemed relevant by the Agency; it is to include a section on medicinal products for human use authorised for the treatment of children; the information provided to the general public is to be worded in an appropriate and comprehensible manner; [Am. 309]

Added(o) assisting the Union and its Member States in the provision of information to health-care professionals and the general public about medicinal products for human use and about veterinary medicinal products evaluated by the Agency;

Added(p) providing scientific advice to undertakings or, as relevant, not-for-profit entities on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products for human use;

Added(q) supporting, through enhanced scientific and regulatory advice, the development of medicinal products which are of major interest from the point of view of public health, including antimicrobial resistance, and in particular from the viewpoint of therapeutic innovation (priority medicines);

Added(r) checking that the conditions laid down in Union legal acts on medicinal products for human use and on veterinary medicinal products and in the marketing authorisations are met in the case of parallel distribution of medicinal products for human use and on veterinary medicinal products authorised in accordance with this Regulation or, as applicable, Regulation (EU) 2019/6;

Added(s) drawing up, at the Commission’s request, any other scientific opinion concerning the evaluation of medicinal products for human use and of veterinary medicinal products or the starting materials used in the manufacture of medicinal products for human use;

Added(t) with a view to the protection of public health, compiling scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products for human use and other veterinary medicinal products available to prevent or treat the effects of such agents;

Added(u) coordinating the supervision of the quality of medicinal products for human use and of veterinary medicinal products placed on the market by requesting testing of compliance with their authorised specifications to the European Directorate for the Quality of Medicines and Healthcare that coordinates with the Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose. The Agency and the European Directorate for the Quality of Medicines and Healthcare shall enter into a written contract for the provision of services to the Agency under this subparagraph;

Added(v) forwarding annually to the budgetary authority aggregated information on procedures for medicinal products for human use and veterinary medicinal products;

Added(w) taking decisions as referred to in Article 6(5) of [revised Directive 2001/83/EC];

Added(x) contributing to the joint reporting with the European Food Safety Authority and European Centre for Disease Prevention and Control on the sales and use of antimicrobials in human and veterinary medicine as well as on the situation as regards antimicrobial resistance in the Union based on contributions received by Member States, taking into account the reporting requirements and periodicity in Article 57 of Regulation (EU) 2019/6. Such joint reporting shall be carried out at least every three years;

Added(y) adopting a decision granting, refusing or transferring an orphan designation;

Added(z) adopting decisions on paediatric investigation plans, waivers and deferrals in relation to medicinal products;

Added(za) providing regulatory support and scientific advice for the development of orphan and paediatric medicinal products;

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

Added(zc) establishing a mechanism of consultation of authorities or bodies active along the life cycle of medicinal products for human use for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the Agency, notably with the SoHO Coordination Board, Medical Devices Coordination Group, the Member State Coordination Group on Health Technology Assessment and national pricing and reimbursement authorities; [Am. 310]

Added(zd) developing coherent scientific assessment methodologies in the fields falling within its mission;