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

Public health community

Period of consultation

31 August to 15 October 2021 (12:00 CET)

Targeted stakeholders

Stakeholders involved in the pharmacovigilance activaties.

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 respected by marketing authorisation 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 optimise 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-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.

The consultation document

The consultation document includes a detailed outline of the changes that are currently considered.

Protection of personal data

The European institutions are committed to protecting and respecting your privacy. As this service/application collects and further processes personal data, Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, is applicable. More information is available here.

Specific privacy statement

Please consult the Privacy Statement

Additional information

• European Commission - Pharmacovigilance
• EMA – Pilot on monitoring Eudravigilance by marketing authorisation holders

How to submit your contribution

Stakeholders are invited to comment on this consultation by 15 October 2021 at the latest.

Responses should preferably be sent to sante-pharmaceuticals-B5ec [dot] europa [dot] eu (subject: TSC%2F2021%2F24%20-%20Targeted%20stakeholder%20consultation%20on%20the%20amendments%20to%20the%20Commission%20Implementing%20Regulation%20No%20%28EU%29%20520%2F2012) (sante-pharmaceuticals-B5[at]ec[dot]europa[dot]eu) referring in the subject line to “TSC/2021/24 - Targeted stakeholder consultation on the amendments to the Commission Implementing Regulation No (EU) 520/2012”.

They can also be sent by post to Directorate-General for Health and Food Safety, Unit B/5, B232 06/085, B-1049 Brussels.

The subject line of the letter or email should contain the reference “TSC/2021/24 - Targeted stakeholder consultation on the amendments to the Commission Implementing Regulation (EU) No 520/2012”.

When submitting your response, please include your name and e-mail address and specify if you are responding as an individual or as a representative of an organisation. If you represent an organisation, please indicate its name and category - company/business; public authority (local, regional, national, international); patient organisation; healthcare professional organisation; academic; NGO; other.

Contact details

Any queries about the targeted stakeholder consultation should be sent to: Unit B5 - Medicines: policy, authorisation and monitoring, Directorate-General for Health and Food Safety sante-pharmaceuticals-B5ec [dot] europa (subject: TSC%2F2021%2F24%20-%20Targeted%20stakeholder%20consultation%20on%20the%20amendments%20to%20the%20Commission%20Implementing%20Regulation%20No%20%28EU%29%20520%2F2012) (sante-pharmaceuticals-B5[at]ec[dot]europa) referring to “TSC/2021/24 - Targeted stakeholder consultation on the amendments to the Commission Implementing Regulation No (EU) 520/2012”.