Resources made available to the Agency in 2007

Competences of the Agency as defined in Regulation (EC) No 726/2004 of the European Parliament and of the Council

A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities. Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases and obviating sources of danger to human health. (…) (Article 152 of the Treaty)

Objectives — To coordinate the scientific resources that the Member States' authorities make available to the Agency for the authorisation and supervision of medicinal products for human and veterinary use. — To provide the MemberStates and the institutions of the European Union with scientific advice on medicinal products for human or veterinary use.

Tasks — To coordinate the scientific evaluation of medicinal products which are subject to Community marketing authorisation procedures. — To coordinate the supervision of medicinal products which have been authorised within the Community (pharmacovigilance). — To advise on the maximum limits for residues of veterinary medicinal products which may be accepted in foodstuffs of animal origin. — To coordinate verification of compliance with the principles of good manufacturing practice, good laboratory practice and good clinical practice. — To record the status of marketing authorisations granted for medicinal products.

1. The Committee for Medicinal Products for Human Use, consisting of one member and one alternate from each MemberState, advises on any question relating to the evaluation of medicinal products for human use. 2. The Committee for Medicinal Products for Veterinary Use, consisting of one member and one alternate from each MemberState, advises on any question relating to the evaluation of veterinary medicinal products. 3. The Committee for Orphan Medicinal Products, consisting of one member and one alternate from each MemberState, advises on any question relating to the evaluation of orphan medicinal products. 4. The Committee on Herbal Medicinal Products, consisting of one member and one alternate from each MemberState, advises on any question relating to the evaluation of herbal medicinal products. 5. The Paediatric Committee, consisting of five members with their alternates of the Committee for Medicinal Products for Human Use, one member and one alternate from each Member State, six members and alternates representing healthcare professionals and patients' associations, responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof. 6. The Management Board consists of one member and one alternate from each MemberState, two representatives of the Commission, two representatives appointed by the European Parliament, two representatives from patients' organisations, one representative from doctors' organisations and one representative from veterinarians' organisations. The Board adopts the work programme and the annual report. 7. The Executive Director is appointed by the Management Board on a proposal from the Commission. 8. External audit Court of Auditors. 9. Discharge authority Parliament acting on recommendation of the Council.

Final budget for 2007: 163,1 million euro (138,7 million euro) Community contribution (excluding subsidy for orphan medicines): 24,3 % (21,6 %) Staff numbers at 31 December 2007: 441 (424) posts provided for in the establishment plan Posts occupied: 422 (395) 95 (77) other staff (auxiliary agents, contract agents seconded national experts, employment agency staff) Total staff: 518 (472) Assigned to the following duties: Operational: 444 (406) Administrative: 74 (66)