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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)
Annex III

Division 2 REPORTING OF SUSPECTED UNEXPECTED SERIOUS ADVERSE REACTIONS (SUSARS) BY THE SPONSOR TO THE AGENCY IN ACCORDANCE WITH ARTICLE 42

United Kingdom

Original text. Later amendments are not shown.

2.1Adverse Events and Causality
2.2Expectedness, unexpectedness and the RSI
2.3Information for the reporting of SUSARs
2.4Follow-up reports of SUSARs
2.5Unblinding treatment allocation

Division 2

Division 2.1 →

Legislation: 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)
Citation: EU Regulation No 536/2014, division 2
Official version: legislation.gov.uk

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Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives. legislation.gov.uk is the official version.

Not legal advice.

👋 Jason Cartwright
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