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Eudralex Volume 3 Requirements for quality documentation concerning biological investigational medicinal products in clinical trials


European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium),

Document Type:
This guideline outlines the requirements for the data to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Products (IMP) containing biological / biotechnology derived substances.

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