Directive 93/41/EEC

Directive 93/41/EEC of 14 June 1993 on the approximation of national measures relating to the placing on the market of high- technology medicinal products, particularly those derived from biotechnology. The Directive offered two routes for authorising medicinal products, a "centralised" procedure and a procedure of "mutual recognition".

According to the Directive, the centralized procedure went through the European European Medicines Evaluation Agency (EMEA). If approved, the Commission issues a decision, valid for 5 years, which is binding on all EU Member States, to authorise the product. The centralized procedure is compulsory for products derived from biotechnology, and optional for other innovative medicinal products.

According to the Directive, the "mutual recognition" procedure involved applications which were made to the Member States selected by the applicant for the marketing authorization and the procedure operates by mutual recognition of national marketing authorisations by the member states of the European Union.