# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 1.1: Plasma-derived medicinal product

Extent: E+W+S+N.I.

For medicinal products derived from human blood or plasma and by derogation from the provisions of Module 3, the dossier requirements mentioned in ‘ Information related to the starting and raw materials ’ , for starting materials made of human blood/plasma may be replaced by a Plasma Master File certified in accordance with this Part.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/III/division/1/division/1.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-III/division-1/division-1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.