Public Consultation Paper on the review of the Guideline on the details of the various categories of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products.


Commission Regulation (EC) No 1234/2008 establishes in its Article 4(2) that the guidelines on the details of the various categories of variations shall be regularly updated, taking into account the recommendations delivered in accordance with Article 5 of this Regulation.

With this public consultation, Directorate General for Health and Consumers intends to consult all stakeholders on a contribution to the review of the above mentioned guidelines. This contribution is an input from the EU Variation Task Force coordinated by EMA and it will form the basis for the review of the Commission variations guidelines.