# 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 30

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

If the IB is not an SmPC, it shall contain a clearly identifiable section called the ‘Reference Safety Information’ (RSI). In accordance with paragraphs 10 and 11 of Annex III, the RSI shall contain product information on the investigational medicinal product and on how to determine what adverse reactions are to be considered as expected adverse reactions, and on the frequency and nature of those adverse reactions.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/E/division/30 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-30
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.