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Guideline

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.

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).
Internet:http://ec.europa.eu/health/files/eudralex/vol-2/c/2ndstepvamfpmf_08_2004.pdf
Origin/Publisher:EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL http://ec.europa.eu/enterprise/index_en.htm
Content:Guideline on Plasma Master File (PMF)and Vaccine Antigen Master File (VAMF) “Second Step”
Document Type:EudraLex