# 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 2.2: Somatic cell therapy medicinal product

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

Somatic cell therapy medicinal product means a biological medicinal product which has the following characteristics:
(a) contains or consists of cells or tissues that have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or of cells or tissues that are not intended to be used for the same essential function(s) in the recipient and the donor;
(b) is presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.
For the purposes of point (a), the manipulations listed in Annex I to Regulation (EC) No 1394/2007, in particular, shall not be considered as substantial manipulations.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/2/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-2/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.