Concept paper on revision of guideline on epidemiological data on blood-transmissible infections

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Download document Concept paper on revision of guideline on epidemiological data on blood-transmissible infections
Reference number EMA/CHMP/BWP/295676/2014
Status draft: consultation closed
First published 2014-08-01
Last updated 2014-08-01

Summary

The guideline on epidemiological data on blood-transmissible infections (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 European Medicines Agency. The first revision of this guideline came into effect in 2011, and it was recognised at that time that a further revision may be needed based on the experience of data submission and evaluation.