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Eudralex Volume 3 GUIDELINE ON ASSESSING THE RISK FOR VIRUS TRANSMISSION – NEW CHAPTER 6 OF THE NOTE FOR GUIDANCE ON PLASMADERIVED MEDICINAL PRODUCTS

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Guideline
Content:
The aim of this chapter is to outline the general principles that manufacturers should follow in performing risk assessments for virus transmission by plasma-derived medicinal products. These risk assessments are required for the substantiation of statements on virus safety and any remaining potential risk in the product information for these products, as outlined in the Note for Guidance on the Warning on Transmissible Agents in SPCs and Package Leaflets for Plasma-derived Medicinal Products (CPMP/BPWG/BWP/561/03).

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