# Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance), Division B: MULTI-STRAIN DOSSIER

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

For certain immunological veterinary medicinal products (foot-and-mouth disease, avian influenza and bluetongue) and by derogation from the provisions of Title II, Part 2 Section C on active substances the concept of the use of a multi-strain dossier is introduced.
A multi-strain dossier means a single dossier containing the relevant data for a unique and thorough scientific assessment of the different options of strains/combinations of strains permitting the authorisation of vaccines against antigenically variable viruses.
Scientific guidelines for the submission and evaluation of multi-strain dossiers shall be adopted by the Agency. The procedure for the submission and evaluation of multi-strain dossiers 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/eur/2019/6/annex/II/title/IV/division/1/division/B (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-IV/division-1/division-B
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.