# 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 5.3.1: Somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s)

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

For somatic cell therapy medicinal products where the mode of action is based on the production of defined active biomolecule(s), the pharmacokinetic profile (in particular distribution, duration and amount of expression) of those molecules shall be addressed, if feasible.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/5/division/5.3/division/5.3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-5/division-5.3/division-5.3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.