This guideline outlines the scientific data requirements for epidemiological data on blood transmissible infections to be included in applications for Plasma Master File certification submitted to the European Medicines Agency (EMA). It is a new revision of the CHMP/EMA Plasma Master File epidemiology guideline (EMEA/CPMP/BWP/125/04) which came into operation in July 2005.

 

 

Posted on the EMA website on 1 June 2015