Guideline on epidemiological data on blood transmissible infections
This guideline (EMA/CHMP/BWP/548524/2008) 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 EMA. The revision of this guideline follows an earlier revision of this guideline (EMA/CHMP/BWP/548524/2008) which came into effect in 2011 and superseded the guideline, which came into operation in July 2005 (Ref. EMEA/CPMP/BWP/125/04).
Click on this link for more information.