Article 51

In order to promote the protection of human and animal health and of consumers of medicinal products throughout the Community, and in order to promote the completion of the internal market through the adoption of uniform regulatory decisions based on scientific criteria concerning the placing on the market and use of medicinal products, the objectives of the Agency shall be to provide the Member States and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, the safety, and the efficacy of medicinal products for human or veterinary use, which is referred to it in accordance with the provisions of Community legislation relating to medicinal products. To this end, the Agency shall undertake the following tasks within its Committees: the coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorization procedures; the transmission of assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; the coordination of the supervision, under practical conditions of use, of medicinal products which have been authorized within the Community and the provision of advice on the measures necessary to ensure the safe and effective use of these products, in particular by evaluating and making available through a database information on adverse reactions to the medicinal products in question (pharmacovigilance); advising on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin in accordance with Regulation (EEC) No 2377/90. coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice and good clinical practice; upon request, providing technical and scientific support for steps to improve cooperation between the Community, its Member States, international organizations and third countries on scientific and technical issues relating to the evaluation of medicinal products; recording the status of marketing authorizations for medicinal products granted in accordance with Community procedures; providing technical assistance for the maintenance of a database on medicinal products which is available for public use; assisting the Community and Member States in the provision of information to health care professionals and the general public about medicinal products which have been evaluated within the Agency; where necessary, advising companies on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.