# 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 5.1.3

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

Given that, due to the nature of advanced therapy medicinal products, their manufacturing process may change during clinical development, additional studies to demonstrate comparability may be required.

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/5/division/5.1/division/5.1.3 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-5/division-5.1/division-5.1.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.