The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
Eudralex Volume 3 GUIDELINE ON THE SCIENTIFIC DATA REQUIREMENTS FOR A PLASMA MASTER FILE (PMF) Revision 1
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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