# Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Division 4.3.2: Pharmacokinetics

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

(a) Conventional pharmacokinetic studies to investigate absorption, distribution, metabolism and excretion shall not be required. However, parameters such as viability, longevity, distribution, growth, differentiation and migration shall be investigated, unless otherwise duly justified in the application on the basis of the type of product concerned.
(b) For somatic cell therapy medicinal products and tissue engineered products, producing systemically active biomolecules, the distribution, duration and amount of expression of these molecules shall be studied.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/4/division/4.3/division/4.3.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-4/division-4.3/division-4.3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.