EMEA: Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products
25.03.2009
EMEA:
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the MAHs. For additional information, this document should be read in conjunction with the European Commission (EC) Guideline on ‘2nd step’ for PMF and Vaccine Antigen Master File (VAMF) certification.
Corrected Procedure: 2nd step of the PMF certification procedure the centrally authorised medicinal products. The objective of this document is to give a practical guidance to the MAHs. For additional information, this document should be read in conjunction with the European Commission (EC) Guideline on ‘2nd step’ for PMF and Vaccine Antigen Master File (VAMF) certification.
The source of the news: http://www.emea.europa.eu/pdfs/human/pmf/37346405en.pdf
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