# 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 9.5

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

Data sources and measurement: for each variable of interest, sources of data and details of methods of assessment and measurement. If the study has used an existing data source, such as electronic health records, any information on the validity of the recording and coding of the data shall be reported. In the case of a systematic review or meta-analysis, description of all information sources, search strategy, methods for selecting studies, methods of data extraction and any processes for obtaining or confirming data from investigators.

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Source: https://www.legislation.gov.uk/eur/2012/520/annex/III/division/3/division/9/division/9.5 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-3/division-9/division-9.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.