# 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 3.2.1.2: Gene therapy medicinal product containing genetically modified cells

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

The finished medicinal product shall consist of genetically modified cells formulated in the final immediate container for the intended medical use. The finished medicinal product may be combined with a medical device or active implantable medical device.
The active substance shall consist of cells genetically modified by one of the products described in section 3.2.1.1 above.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/3/division/3.2/division/3.2.1/division/3.2.1.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-3/division-3.2/division-3.2.1/division-3.2.1.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.