# 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 1.2: Vaccines

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

For vaccines for human use and by derogation from the provisions of Module 3 on ‘ Active substance(s) ’ , the following requirements when based on the use of a Vaccine Antigen Master File system shall apply.
The marketing authorisation application dossier of a vaccine other than human influenza vaccine, shall be required to include a Vaccine Antigen Master File for every vaccine antigen that is an active substance of this vaccine.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/III/division/1/division/1.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-III/division-1/division-1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.