# 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 3

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

The efficacy of an immunological veterinary medicinal product shall be demonstrated for each category of target animal species recommended for vaccination, by each recommended route of administration and using the proposed schedule of administration. The influence of passively acquired and maternally derived antibodies on the efficacy of a vaccine shall be adequately evaluated, if appropriate. Unless justified, the onset and duration of immunity shall be established and supported by data from trials.

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Source: https://www.legislation.gov.uk/eur/2019/6/annex/II/title/II/chapter/II/division/A/division/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-II/chapter-II/division-A/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.