Eudralex Volume 3 TESTS ON SAMPLES OF BIOLOGICAL ORIGIN
Title:
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:
Guideline
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.