The European Commission is currently reviewing the procedures for post-authorisation changes to the terms of a marketing authorisation for human medicines. This review pertains to Commission Regulation (EC) No 1234/2008, alongside the variations guidelines within the existing legal framework of Regulation (EC) No 726/2004 and Directive 2001/83/EC.
In this context, the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission are inviting pharmaceutical industry representatives and other interested parties to provide feedback on the proposed amendments. These amendments specifically address the guidelines detailing the various categories of variations and the operation of the variations procedures.
Key Points:
- Regulations under review: Commission Regulation (EC) No 1234/2008, Regulation (EC) No 726/2004, and Directive 2001/83/EC.
- Focus: Guidelines on categories of variations and procedures.
You can find the proposed changes documents here.
How to Participate:
Before submitting your comments, please consolidate your feedback at your EU trade industry association or organisational level. All feedback must be submitted exclusively through the EU survey tool linked below by 23 August 2024.
We encourage all stakeholders to review the proposed amendments and provide their valuable input to ensure the guidelines remain effective and relevant.
For further information, you can contact us at: [email protected]
