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Eudralex Volume 3 Concept Paper: Revision of the Note for guidance on Plasma-Derived Medicinal Products

Origin/Publisher:

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

Document Type:
concept Paper
Content:
Two major issues necessitate the revision of the Note for Guidance (NfG): the knowledge on the viral safety issues of plasma-derived medicinal products is still in evolution and the legislative situation has changed significantly during the last few years.

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