Variations

Always up to date

Your products and their marketing authorisation dossiers change in the course of time – either to remain in line with the latest scientific and technological developments or to adapt to market-related and legal changes.

Comprehensive service from one source

We submit your variation applications quickly and successfully to the competent authorities. We will be glad to clarify the variation type (IA, IB, II) for you in advance, prepare the variation documentation accordingly and perform the procedure with all the authorities involved and/or the EMA. We also implement changes in accordance with the national requirements of countries outside the EU (Emering Markets)

Please note:

As from January 1, 2010 a modified system applies in Europe. For example, certain minor amendments need only be reported in the "Annual Reporting System". Naturally, we will also be glad to perform this task on your behalf. Your personal contact from our Lifecycle Management team will keep an eye on things for you.