Targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities

The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities.

About Commission Implementing Regulations

A Commission Implementing Regulation is a legally binding act of the European Union. It is directly applicable in all member states of the European Union, akin to national legislation.

  • Implementing regulations
    • take precedent over national legislation in case the two contradict one another
    • are always limited in scope. Their aim is to ensure uniform implementation of European legislation, and the subject-matter of any implementing regulations serves that goal alone.
    • are directly applicable and need not be transposed into national legislation. This ensures implementation takes a similar shape in each individual member state. Member states are required to implement implementing regulations.
    • can only be issued when European legislation stipulates further measures are called for to ensure uniform implementation of said legislation by the member states. The mandate for implementing regulations is limited to what is necessary for uniform implementation, no additional, complementary or adjoining rules can be set. Implementing regulations deal with very specific policies and often address highly technical details of legislation.

The EU has two procedures by means of which implementing regulations can be established. In both procedures the Commission initiates and ultimately decides on implementing regulations. A committee of representatives of the member states can either advise on or has to approve of implementing regulations.

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

The  Commission Implementing Regulation (EU) 520/2012 (IR) on the performance of pharmacovigilance activites was adopted in 2012. It outlines the practical details to be respected by marketing authorisation holders, national competent authorities and the European Medicines Agency (EMA).

What is the consultation about?

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 optimise existing implementing measures like the Commission Implementing Regulation (EU) 520/2012 (IR). Whilst the overall experience with the IR is good, following consultation with the European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC), the need for some targeted amendments has been identified. This is 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-authorisation 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.

Who are targeted stakeholders?

These are are stakeholders involved in pharmacovigilance activaties.

The consultation document

The seven page consultation document includes a detailed outline of the changes that are currently being considered. The changes to the IR are also presented in a present/proposed format.

Where should you submit your response to the consultation?

Please refer to the consultation document for instruction on how and where to submit your response to the consultation.

What are the start and end dates of the consultation?

Start date: 31 August 2021

End date: 15 October 2021