# 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 12

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

If the initial report of a SUSAR referred to in point (a) of Article 42(2) (fatal or life-threatening) is incomplete, for example if the sponsor has not provided all the information within seven days, the sponsor shall submit a completed report based on the initial information within an additional eight days.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/III/division/2/division/2.4/division/12 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.4/division-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.