- Tous > Quality and Safety: Medicines > Quality Assurance
- Tous > Quality and Safety: Medicines > Regulatory Support
- Tous > Quality and Safety: Medicines > Safety and Efficacy
- Mots-clés > authorisation procedure
- Mots-clés > European Medicines Agency (EMA)
- Mots-clés > European Union (EU)
- Mots-clés > legislation
- Mots-clés > marketing authorization
- Mots-clés > medicinal products - evaluation
- Mots-clés > medicinal products - marketing
- Mots-clés > pharmacovigilance
- Mots-clés > registration
- Mots-clés > regulation
(2004; 33 pages)
Article 71 of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products provides that, within six years of the entry into force of the Regulation, the Commission is to publish a general report on the experience acquired as a result of the operation of the procedures laid down in the Regulation.
In the light of the Commission's report on the experience gained, it has proved necessary to improve the operation of the authorisation procedures for the placing of medicinal products on the market in the Community and to amend certain administrative aspects of the European Agency for the Evaluation of Medicinal Products. In addition, the name of that Agency should be simplified and changed to the European Medicines Agency, (hereinafter referred to as the ‘Agency’)...