Article 57
1. The Agency shall 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, safety and 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, acting particularly through its committees, shall undertake the following tasks: (a) coordination of the scientific evaluation of the quality, safety and efficacy of medicinal products which are subject to Community marketing authorisation procedures; (b) transmitting on request and making publicly available assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; (c) coordination of the supervision, under practical conditions of use, of medicinal products which have been authorised 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 evaluation, coordination of the implementation of pharmacovigilance obligations and the monitoring of such implementation; (d) ensuring the dissemination of information on adverse reactions to medicinal products authorised in the Community, by means of a database permanently accessible to all Member States; health-care professionals, marketing authorisation holders and the public shall have appropriate levels of access to these databases, with personal data protection being guaranteed; (e) assisting Member States with the rapid communication of information concerning pharmacovigilance to health-care professionals. (f) distributing appropriate pharmacovigilance information to the general public; (g) 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; (h) providing scientific advice on the use of antibiotics in food-producing animals in order to minimise the occurrence of bacterial resistance in the Community; this advice shall be updated when needed; (i) coordinating the verification of compliance with the principles of good manufacturing practice, good laboratory practice, good clinical practice and the verification of compliance with pharmacovigilance obligations; (j) upon request, providing technical and scientific support in order to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the evaluation of medicinal products, in particular in the context of discussions organised in the framework of international conferences on harmonisation; (k) recording the status of marketing authorisations for medicinal products granted in accordance with Community procedures; (l) creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner; (m) assisting the Community and Member States in the provision of information to health-care professionals and the general public about medicinal products evaluated by the Agency; (n) advising undertakings on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products; (o) checking that the conditions laid down in Community legislation on medicinal products and in the marketing authorisations are observed in the case of parallel distribution of medicinal products authorised in accordance with this Regulation; (p) drawing up, at the Commission's request, any other scientific opinion concerning the evaluation of medicinal products or the starting materials used in the manufacture of medicinal products; (q) with a view to the protection of public health, compilation of scientific information concerning pathogenic agents which might be used in biological warfare, including the existence of vaccines and other medicinal products available to prevent, or to treat, the effects of such agents; (r) coordination of the supervision of the quality of medicinal products placed on the market by requesting testing of compliance with their authorised specifications by an Official Medicines Control Laboratory or by a laboratory that a Member State has designated for that purpose; (s) forwarding annually to the budgetary authority any information relevant to the outcome of the evaluation procedures. 2. The database provided for in paragraph 1(l) shall include the summaries of product characteristics, the patient or user package leaflet and the information shown on the labelling. The database shall be developed in stages, priority being given to medicinal products authorised under this Regulation and those authorised under Chapter 4 of Title III of Directive 2001/83/EC and of Directive 2001/82/EC respectively. The database shall subsequently be extended to include any medicinal product placed on the market within the Community. Where appropriate, the database shall also include references to data on clinical trials currently being carried out or already completed, contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC. The Commission shall, in consultation with the Member States, issue guidelines on data fields which could be included and which may be accessible to the public.