# 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 A.3: Pharmacokinetics

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

Basic pharmacokinetic data concerning a new active substance are required in the context of assessment of the clinical safety and efficacy of the veterinary medicinal product.
The objectives of pharmacokinetic studies in the target animal species can be divided into three main areas:
(i) descriptive pharmacokinetics leading to the determination of basic parameters;
(ii) use of these parameters to investigate the relationships between dosage regimen, plasma and tissue concentration over time and pharmacological, therapeutic or toxic effects;
(iii) where appropriate, to compare the kinetics between different target species and to explore possible species differences having an impact on target animal safety and efficacy of the veterinary medicinal product.
In the target animal species, pharmacokinetic studies are, as a rule, necessary as a complement to the pharmacodynamic studies to support the establishment of effective dosage regimens (route and site of administration, dose, dosing interval, number of administrations, etc.). Additional pharmacokinetic studies may be required to establish dosage regimens according to certain population variables.
Where pharmacokinetic studies have been submitted under Part 3 cross reference to such studies may be made.
In the case of new combinations of known substances which have been investigated in accordance with the provisions of this Directive, pharmacokinetic studies of the fixed combination are not required if it can be justified that the administration of the active substances as a fixed combination does not change their pharmacokinetic properties.
Appropriate bioavailability studies shall be undertaken to establish bioequivalence:
when comparing a reformulated veterinary medicinal product with the existing one,
where necessary for the comparison of a new method or route of administration with an established one.

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