Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1

Title:
Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1

https://www.gmp-compliance.org/files/guidemgr/379403enfin.pdf

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 guidance on the structure and requirements for presentation of data on starting material in a Plasma Master File (PMF). This guidance shall also apply when the PMF certification scheme is not followed.

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