# 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), Article 43: Annual reporting by the sponsor to the Agency

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

1. Regarding investigational medicinal products other than placebo, the sponsor shall submit annually through the database referred to in Article 40(1) to the Agency a report on the safety of each investigational medicinal product used in a clinical trial for which it is the sponsor.
2. In the case of a clinical trial involving the use of more than one investigational medicinal product, the sponsor may, if provided for in the protocol, submit a single safety report on all investigational medicinal products used in that clinical trial.
3. The annual report referred to in paragraph 1 shall only contain aggregate and anonymised data.
4. The obligation referred to in paragraph 1 starts with the first authorisation of a clinical trial in accordance with this Regulation. It ends with the end of the last clinical trial conducted by the sponsor with the investigational medicinal product.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/43 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-43
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.