# 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 5.2.1: Human pharmacokinetic studies

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

Human pharmacokinetic studies shall include the following aspects:
(a) shedding studies to address the excretion of the gene therapy medicinal products;
(b) biodistribution studies;
(c) pharmacokinetic studies of the medicinal product and the gene expression moieties (e.g. expressed proteins or genomic signatures).

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/5/division/5.2/division/5.2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-5/division-5.2/division-5.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.