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Eudralex Volume 3 TESTS ON SAMPLES OF BIOLOGICAL ORIGIN

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Guidelien
Content:
This document provides basic guidance on the presentation of data validating test procedures carried out for toxicological and pharmacological studies as well as for clinical trials provided for by Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation in respect of a medicinal product.

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