Consultation on Amendments on Pharmacovigilance Activities

Recommendation

5/6 June 2024

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A targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 (IR) on pharmacovigilance activities has been published on the EC website. Comments and proposals received will be published and considered in the work leading to the revision of the IR.

Objective of the consultation

The Commission Implementing Regulation (IR) on the performance of pharmacovigilance activities was adopted in 2012. It outlines the practical details to be followed by marketing authorization holders (MAHs), national competent authorities and the European Medicines Agency (EMA). Since EU inspectors have frequently raised findings in the area of contracts / agreements with third parties performing certain pharmacovigilance services for MAHs, it is considered that it would be beneficial to enhance MAHs' oversight regarding compliance controls of third parties.

The proposed revision focuses on the following sections of the IR:

• Chapter I - Pharmacovigilance system master file (e.g. subcontracting),
• Chapter III - Minimum requirements for monitoring of data in Eudravigilance (e.g. use as additional source of information to support existing pharmacovigilance processes and resource to evaluate signals detected from other sources). See also EMA – Pilot on monitoring Eudravigilance by MAHs,
• Chapter IV - Use of terminology, formats and standards (e.g. use of the ISO ICSR standard based on the ICH E2B(R3) modalities which will become mandatory as of 30 June 2022),
• Chapter V - Transmission of suspected adverse reactions (e.g. literature referencing in individual case safety reports by using the digital object identifier (DOI) when reporting suspected adverse reactions),
• Chapter VIII - Post-authorization safety studies (e.g. register and include the study protocol of all imposed non-interventional post-authorization studies in the EU PAS Register before starting with the data collection).

Stakeholders involved in pharmacovigilance activities are invited to comment on this consultation by 15 October 2021 at the latest. More information is available under Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 published on the EC website.