# Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), Article 24: Signal detection audit trail

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

1. The national competent authorities and the Agency shall keep an audit trail of their signal detection activities conducted in the Eudravigilance database and of the relevant queries and their results.
2. The audit trail shall allow traceability of how signals have been detected and of how validated and confirmed signals have been assessed.

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Source: https://www.legislation.gov.uk/eur/2012/520/article/24 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/article-24
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.