# 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), Division 11.2

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

Limitations: limitations of the study taking into account circumstances that may have affected the quality or integrity of the data, limitations of the study approach and methods used to address them, sources of potential bias and imprecision, and validation of the events. Both the direction and magnitude of potential biases shall be discussed.

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Source: https://www.legislation.gov.uk/eur/2012/520/annex/III/division/3/division/11/division/11.2 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-3/division-11/division-11.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.