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