# 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 5: Informed consent applications

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

Applications based on Article 13c shall contain the data described in Part 1 of Title 1 of this Annex, provided that the marketing authorisation holder for the original veterinary medicinal product has given the applicant his consent to refer to the content of Parts 2, 3 and 4 of the dossier of that product. In this case, there is no need to submit quality, safety and efficacy detailed and critical summaries.

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Source: https://www.legislation.gov.uk/eur/2019/6/annex/II/title/III/division/5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-III/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.