Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures

The proposed amendments aim to make the lifecycle management of medicinal products for human use more efficient and future-proof.

The European Commission is reviewing the rules governing the procedures for post-authorisation changes to the terms of a marketing authorisation for human medicines. 

This concerns the Commission Regulation (EC) No 1234/2008 together with the variations guidelines within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC. 

In this context, EMA, the Heads of Medicines Agencies (HMA) and the European Commission are inviting pharmaceutical industry representatives and other interested parties to comment on the proposed amendment. This refers specifically to the guidelines on the details of the different categories of variations and operation of the variations procedures.

Find the documents with the proposed changes in the 'Stakeholder consultation' section on this page (a clean version and one with track changes). 

Before replying, please consolidate your comments at your EU trade industry association / organisation level.  

Please submit your feedback - only - through the EU survey tool below by 23 August 2024:

• EU survey: Submission of comments on the revision of Variation Guidelines

Keywords: Human medicines, regulatory and procedural guidance

Stakeholder consultation

Executive summary for proposed amendments to the European Commission guidelines on variations categories and procedures

Reference Number: EMA/269251/2024

European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation - clean version

Draft: consultation closed Consultation dates: 13/06/2024 to 23/08/2024 Reference Number: EMA/269287/2024 Summary:

The proposed amendments and an executive summary are available on the EMA corporate website at Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures. Please consolidate your comments at your EU trade industry association / organisation level and submit them through the dedicated EU survey tool only: EU survey: Submission of comments on the revision of Variation Guidelines.

European Commission guidelines on variations categories and procedures: Proposal for stakeholder consultation - in tracked changes