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  • Title: European project concerning the guidelines on medicinal products derived from human blood and plasma.
    Author: Horaud F.
    Journal: Dev Biol Stand; 1991; 75():237-40. PubMed ID: 1794627.
    Abstract:
    The Biotechnology/Pharmacy Working Party (BPWP) decided in October 1989 to put on its working programme the elaboration of a guideline on medicinal products derived from human blood and plasma. This has been determined by the adoption of Directive 89/381/EEC extending the scope of the EEC pharmaceutical legislation to medicinal products derived from human plasma. Because Directive 89/381/EEC will come into force on 1 Jan. 1992, the existing products derived from plasma should be reviewed in order to harmonize them with the EEC requirements before 1 Jan. 1993. In this paper, I give an account of the main points and questions addressed by the BPWP draft in order to stimulate comments from producers and regulatory agencies.
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