# 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 2.2: Pharmacokinetics

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

Data on the fate of the active substance and its metabolites in the species used in the toxicological studies shall be provided, covering absorption, distribution, metabolism and excretion (ADME). The data shall be related to the dose/effect findings in the pharmacological and toxicological studies, to determine adequate exposure. Comparison with the pharmacokinetic data obtained in the studies on the target species, Part 4, Chapter I, Section A.2, shall be included in Part 4 in order to determine the relevance of the results obtained in the toxicology studies for the toxicity to the target species.

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Source: https://www.legislation.gov.uk/eur/2019/6/annex/II/title/I/part/3/division/A/chapter/I/division/2/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2019-6/annex-II/title-I/part-3/division-A/chapter-I/division-2/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.