Resources made available to the Agency in 2009

(Regulation (EC) No 726/2004 of the Parliament and of the Council)

A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. Union action, which shall complement national policies, shall be directed towards improving public health, preventing physical and mental illness and diseases, and obviating sources of danger to physical and mental health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education, and monitoring, early warning of and combating serious cross-border threats to health. (Article 168 of the TFEU)

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 Member States 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 Union marketing authorisation procedures. — To coordinate the supervision of medicinal products which have been authorised within the Union (pharmaco-vigilance). — 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 (CHMP), consisting of one member and one alternate from each Member State and 5 coopted members, advises on any question relating to the evaluation of medicinal products for human use. 2 — The Committee for Medicinal Products for Veterinary Use (CVMP), consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of veterinary medicinal products. 3 — The Committee for Orphan Medicinal Products (COMP), consisting of one member and one alternate from each Member State, advises on any question relating to the evaluation of orphan medicinal products. 4 — The Committee on Herbal Medicinal Products (HMPC), consisting of one member and one alternate from each Member State and 5 coopted members, advises on any question relating to the evaluation of herbal medicinal products. 5 — The Paediatric Committee (PDCO), consisting of one member and one alternate from each Member State, six members and alternates representing healthcare professionals and patients’ associations, is responsible for the scientific assessment and agreement of paediatric investigation plans and for the system of waivers and deferrals thereof. 6 — The Committee for Advanced Therapy (CAT), consisting of five members of CHMP and their (five) alternates, one member and one alternate from each Member State, two members and two alternates representing clinicians, two members and two alternates representing patients’ associations, is responsible for any question relating to the assessment of advanced therapy medicinal products and ATMP certification and classification. 7 — The Management Board consists of one member and one alternate from each Member State, 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. 8 — The Executive Director is appointed by the Management Board on a proposal from the Commission. 9 — Internal audit Internal Audit Service of the Commission. 10 — External audit Court of Auditors. 11 — Discharge authority Parliament, acting on a recommendation from the Council.

Budget 194,389 million euro (182,895 million euro); Union contribution: 18,7 % (18,8 %) Staff at 31 December 2009 Posts provided for in the establishment plan: 530 (481) Posts occupied: 511 (469) 160 (104) other staff (contract staff, seconded national experts, employment agency staff) Total staff: 664 (587) Allocated to: Operational: 520 (483) Administrative: 144 (104)