# 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 4.3: Observations in humans

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

Information shall be provided showing whether the pharmacologically active substances of the veterinary medicinal product are used as medicinal products in human therapy; if this is so, a compilation shall be made of all the effects observed (including adverse reactions) in humans and of their cause, to the extent that they may be important for the assessment of the safety of the veterinary medicinal product, where appropriate including results from published studies; where constituents of the veterinary medicinal products are themselves not used or are no longer used as medicinal products in human therapy, the reasons shall be stated.

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Source: https://www.legislation.gov.uk/eur/2019/6/annex/II/title/I/part/3/division/A/chapter/I/division/4/division/4.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-I/part-3/division-A/chapter-I/division-4/division-4.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.