Application for variation to a marketing authorisation
08 January 2010
The new variation application form has been published on the European Commission website and must be used from 1 January 2010 for all marketing authorisation variations submissions. Click on the link below to download.
Application for variation to a marketing authorisation.
A user guide on how to use the new variation application form has also been published by the European Medicines Agency and CMDh.
Explanatory notes on Variation Application Form (Human medicinal products only) (January 2010)