Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures
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:
Keywords: Human medicines, regulatory and procedural guidance
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