# 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 5

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

In determining whether an adverse event is unexpected, consideration shall be given to whether the event adds significant information on the specificity, increase of occurrence, or severity of a known, already documented serious adverse reaction.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/III/division/2/division/2.2/division/5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.2/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.