# Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, Division A: VACCINE ANTIGEN MASTER FILE

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

For particular immunological veterinary medicinal products and by derogation from the provisions of Title II, Part 2 Section C on active substances, the concept of a Vaccine Antigen Master File is introduced.
For the purpose of this Annex, a Vaccine Antigen Master File means a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information on quality concerning each of the active substances, which are part of this veterinary medicinal product. The stand-alone part may be common to one or more monovalent and/or combined vaccines presented by the same applicant or marketing authorisation holder.
Scientific guidelines for the submission and evaluation of a vaccine antigen master file shall be adopted by the Agency. The procedure for the submission and evaluation of a vaccine antigen master file shall follow the guidance published by the Commission in The rules governing medicinal products in the European Union , Volume 6B, Notice to Applicants.

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Source: https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/IV/division/1/division/A (the official version)
Page: https://openlegislation.uk/eu-directive-2001-82/annex-I/title-IV/division-1/division-A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.