24 June 2024

Public Consultation on Variations Classification Guideline

We would like to draw your attention to the ongoing public consultation on the Variations Classification Guideline, available until August 23, 2024. The proposed amendments can be reviewed on the following webpage:: Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures. The Heads of Medicines Agencies (HMA) and the European Commission invite representatives from the pharmaceutical industry and other stakeholders to comment on these proposed changes. This refers specifically to the guidelines on the details of the different categories of variations and the procedures for their implementation. You may submit your feedback by completing the following survey: Submission of comments on the revision of Variation Guidelines.