# 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 22

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

If following unblinding, an event turns out to be a SUSAR the reporting rules for SUSARs set out in Article 42 and in Section 2 of this Annex shall apply.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/III/division/2/division/2.5/division/22 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.5/division-22
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.