Information about the change in approach to the validation of the type II variation

State Institute for Drug Control informs the MAHs about a change in the approach to the validation of Type II variations.  

In July 2014 an updated document "Questions and Answers to Variations" has been published on the CMDh website. Within this document a new question 4.17 explaining how to submit variations when several changes are falling under the same category in the classification guideline was issued. In this Q/A it is explicitly mentioned that each trigger in a variation application results in a single variation which may be submitted in a grouped application.

From July 2014 therefore the State Institute for Drug Control proceeds in accordance with this CMDh recommendation and does not accept variations that are unconnected, under a single Type II variation, particularly with respect to type II variations under classification C.I.4.


Marketing Authorisation Branch

12. 12. 2014