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