Variations to marketing authorisations
Published:
Changes
The marketing authorisation holder must keep up to date with scientific and technical developments related to medicinal products. When changes to documentation and/or product information are required, the MAH must submit a variation application to NOMA.
Page contents
Medicinal products for human use
The Variation Regulation (EU) 1234/2008 applies to medicinal products for human use and to all procedures.
Application form and guidance for completing the application form
Important documents for work related to variation applications
- The
Commissions guidance
on the details of the various categories of the procedures, including annexes. -
CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008
Medicinal products for veterinary use
The Regulation on veterinary medicinal products (EU) 2019/6 applies to veterinary medicinal products and to all procedure types.
Application form and guidance for completing the application form
Important documents for work related to variation applications
-
The Commission’s guidance on variations to veterinary medicinal products requiring assessment (VRA) and not requiring assessment (External link) (VNRA). The links include Annex with the Commission’s classification table indicating conditions and documentation requirements.