# 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 40: Electronic database for safety reporting

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

1. The European Medicines Agency established by Regulation (EC) No 726/2004 (the ‘Agency’) shall set up and maintain an electronic database for the reporting provided for in Articles 42 and 43. That database shall be a module of the database referred to in Article 24 of Regulation (EC) No 726/2004 (the ‘Eudravigilance database’).
2. The Agency shall, in collaboration with Member States, develop a standard web-based structured form for the reporting by sponsors to the database referred to in paragraph 1 of suspected unexpected serious adverse reactions.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/40 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-40
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.