Application for Marketing Authorisation and Variations


The new application forms for marketing authorization applications and variations are available at

Variations not requiring assessment (VNRA)
Variations not requiring assessment have to be submitted and processed directly via the UPD. Currently, there are still technical problems and delays in uploading data. For more information, please visit, EMA support can be contacted via the following link: Please bear in mind that such changes can also be submitted up to 30 days retrospectively.

Variations requiring assessment (VRA)
Changes requiring assessment (VRA) have to be submitted as usually via CESP and the data are shared with all MS via CTS.

Change of ownership
Information on change of ownership acc. to § 25 AMG please find here.


Further inquiry note