- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Regulatory Support
(1998; 49 pages) [French] [Spanish]
The European Community has developed a comprehensive legislative network to facilitate the free movement of goods, capital, services and persons in the Community. According to Directives 65/65/EEC  and 75/318/EEC , pharmaceutical products require pre-marketing approval before gaining access to the market. Requirements for the documentation of quality, safety, and efficacy, the dossier and expert reports are laid down in Directive 91/507/EEC . Article 39 para 2 of Directive 75/319/EEC  obliged Member States to check all products on the market at that time, with a deadline of 12 years, to determine whether they met the requirements of these directives. Countries have taken different approaches in reviewing phytomedicines.