In brief

On 31 August 2021 the European Commission (the "Commission") launched a consultation on the operation of Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities (the "Implementing Regulation") targeted at stakeholders involved in such activities. We have set out our key takeaways from the announcement of this consultation below.

What is Commission Implementing Regulation (EU) 520/2012?

  • The Implementing Regulation was originally adopted in 2012 and summarizes the operational aspects of Directive 2010/84/EU and Regulation (EU) No 1235/2010, both of which regulate the safety monitoring of medicines across the EU. The practical details set out in the Implementing Regulation must be adhered to by marketing authorization holders, national competent authorities and the European Medicines Agency (EMA).

What is the aim of the consultation?

  • In accordance with the Pharmaceutical Strategy for Europe, the Commission has a responsibility to regularly review the general pharmaceutical regulations as well as the Implementing Regulation. While the Implementing Regulation has operated effectively according to the consultation document, the Commission's review, conducted in conjunction with the EMA and Pharmacovigilance Risk Assessment Committee, has identified aspects of the Regulation which need to be updated to account for new technical standards. Therefore, the consultation will inform amendments to the following sections of the Implementing Regulation:
  • Chapter I: The contents of the Pharmacovigilance System Master File (e.g. subcontracting);
  • Chapter III: Minimum requirements for the monitoring of data in the Eudravigilance database (e.g. use as an additional information source in order to support existing pharmacovigilance procedures);
  • Chapter IV: The use of pharmacovigilance terminology, formats and standards (e.g. use of the ISO/ICH E2B(R3) modalities which will become mandatory as of 30 June 2022;
  • Chapter V: The transmission of information pertaining to suspected adverse reactions (referencing literature in individual case safety reports using digital objective identifier (DOI) when reporting suspected adverse reactions); and
  • Chapter VIII: Post-authorization safety studies (e.g. registering and including the study protocol of all imposed non-interventional post-authorization studies in the EU PAS Register before commencing the collection of data).

Next steps

  • While the consultation will focus on amendments to the areas set out above, stakeholders are also invited to submit additional proposals on how the Implementing Regulation could be improved. These proposals will be assessed by the Commission throughout the amendment process.
  • If you are interested in contributing to the consultation, please submit a response to [email protected] with the following subject line: "TSC/2021/24 - Targeted stakeholder consultation on the amendments to the Commission Implementing Regulation No (EU) 520/2012". The consultation will run until 15 October 2021.