# 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 a): Principles

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

For the purposes of this Annex:
Vaccine Antigen Master File shall mean a stand-alone part of the marketing authorisation application dossier for a vaccine, which contains all relevant information of biological, pharmaceutical and chemical nature concerning each of the active substances, which are part of this 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.
A vaccine may contain one or several distinct vaccine antigens. There are as many active substance(s) as vaccine antigen(s) present in a vaccine.
A combined vaccine contains at least two distinct vaccine antigens aimed at preventing a single or several infectious diseases.
A monovalent vaccine is a vaccine, which contains one vaccine antigen aimed at preventing a single infectious disease.

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