Targeted Stakeholder Consultation on the Amendments to Commission Implementing Regulation (EU) 520/2012 on Pharmacovigilance Activities

On 1 September 2021 the European Commission announced the targeted stakeholder consultation from 31 August to 15 October 2021.

The Commission Implementing Regulation (IR) on the performance of pharmacovigilance activities was adopted in 2012. It outlines the practical details to be respected by marketing authorization holders, national competent authorities and the European Medicines Agency (EMA).

As part of the Pharmaceutical Strategy for Europe, the Commission is not only committed to evaluate and review the general pharmaceutical legislation, but also to update and optimize existing implementing measures like the IR. The overall experience with the IR is good. However, following consultation with the EMA and the Pharmacovigilance Risk Assessment Committee, the need for some targeted amendments has been identified to take account of the experience gained and to update certain provisions in view of new technical standards being applied. The aim of this consultation is to inform and consult on those amendments. They focus on the following sections of the IR:

  • Chapter I - Pharmacovigilance system master file
  • Chapter III - Minimum requirements for the monitoring of data in the Eudravigilance database
  • Chapter IV - Use of terminology, formats and standards
  • Chapter V - Transmission of suspected adverse reactions
  • Chapter VIII - Post-authorization safety studies

While this consultation primarily seeks the stakeholders’ feedback on those proposed amendments, the Commission welcomes any additional remarks that could improve the application of the IR.

The comments and proposals received will be published and considered in the work leading to the amendments of the IR.

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