# 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), Article 21: Substantial modification of aspects covered by Parts I and II of the assessment report

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

1. Where a substantial modification relates to aspects covered by Parts I and II of the assessment report, the application for authorisation of that substantial modification shall be validated in accordance with Article 17.
2. The aspects covered by Part I of the assessment report shall be assessed in accordance with Article 18 and the aspects covered by Part II of the assessment report shall be assessed in accordance with Article 22.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/21 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.