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Eudralex Volume 3 CONCEPT PAPER ON the revision of the GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS EMEA/CPMP/BWP/125/04)requirements for a Plasma Master File


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

Document Type:
Draft Revision Guideline
Guideline for inclusion in the Guideline on the Scientific data requirements for a Plasma Master File (EMEA/CPMP/BWP/3794/03).The requirement to collect epidemiological data on blood transmissible infections is intended to obtain information on the infection risk in a specific donor population and is thus an essential part of the measures taken to ensure an adequate selection of donors of blood and plasma. The purpose of these data is to characterise the donor population with respect to infection risk, and to allow comparison of risks between donor populations of individual collection centres.

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