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 2C Guideline on the “2nd step”, when the Competent Authority has to take into account the effect of the PMF/VAMF certification on the concerned medicinal product(s).

Origin/Publisher:

EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL http://ec.europa.eu/enterprise/index_en.htm

Document Type:
EudraLex
Content:
Guideline on Plasma Master File (PMF)and Vaccine Antigen Master File (VAMF) “Second Step”

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