# 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 4.2: Specific requirements for gene therapy medicinal products

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

In order to determine the extent and type of non-clinical studies necessary to determine the appropriate level of non-clinical safety data, the design and type of the gene therapy medicinal product shall be taken into account.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/4/division/4.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-4/division-4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.