# 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 4.1: Special studies

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

For particular groups of substances or if the effects observed during repeated dose studies in animals include changes indicative of e.g. immunotoxicity, neurotoxicity- or, endocrine dysfunction, further testing shall be required, e.g. sensitisation studies or delayed neurotoxicity tests. Depending on the nature of the product, it may be necessary to conduct additional studies to assess the underlying mechanism of the toxic effect or the irritation potential. Such studies shall usually be conducted with the final formulation.
The state of scientific knowledge and established guidance shall be taken into account when designing such studies and evaluating their results.

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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/4.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-I/part-3/division-A/chapter-I/division-4/division-4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.