- Directive 75/318/EEC
Directive 75/318/EEC of
20 May 1975on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products. This directive of the European Unionsought to bring the benefits of innovative pharmaceuticals to patients across Europeby introducing the mutual recognition, by Member States, of their respective national marketing authorisations.
The Directive states that Member States shall take all appropriate measures to ensure that the applications for marketing authorization, are submitted by the applicants in accordance with the guidelines of the Directive.
Regulation of therapeutic goods
European Medicines Agency
* [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31975L0318:EN:HTML Council Directive 75/318/EEC of
20 May 1975]
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