Can a DMF-update be submitted in Switzerland as a type II B.I.z variation application, identically to the EU?
There are numerous cases of DMF-updates which were submitted in the EU as type II B.I.z variation applications. This happens with reference to Appendix III of the Commission Regulation (EC) 1234/2008 (specifications for grouping in the EU) and/or CMDh/CMDv: Q&A (question 3.4 of the list for the submission of variations according to Commission Regulation (EC) 1234/2008). This type of grouping was previously taken into account by Swissmedic but will longer beaccepted in the future. The specific changes should continue to be listed in the designated variation templates [B.I.a.1 (New active substance manufacturer); B.I.a.2 (Change in the manufacturing process); B.I.a.3 (Change in batch size); B.I.a.4 (Change to IPCs); B.I.b.1 (Change in the specification parameters); etc.] and be submitted as a multiple application.
