# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Division 8

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

If a substantial modification involves changes to entries on the EU application form referred to in Annex I, a revised version of that form shall be submitted. The fields affected by the substantial modification shall be highlighted in the revised form.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/II/division/F/division/8 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-F/division-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.