Signal submission with AMZV amendments

What is the correct procedure for the submission of signal texts if amendments in line with the revised AMZV are ongoing in parallel?

When making a signal submission, amendments that have been added as the result of parallel applications (e.g., amendment in line with the revised AMZV) and that have been submitted to Swissmedic but not yet approved must be reversed. However, compulsory changes made as a result of the new templates from Swissmedic, such a titles and compulsory fixed text (e.g., ElViS reference), must be kept in the event of a signal submission, and a comment added where necessary. It is possible to explain the situation by adding a corresponding comment in the “Variations and extensions TPO4” form, stating that further changes to the product information texts (e.g., Full Declaration, amendment/addition of extra titles, formatting changes, amendment of MedDRA terms, etc.) have already been submitted in one or more parallel ongoing applications and are in the assessment stage, but that the texts submitted with the signal have only implemented the compulsory changes from the new templates. Swissmedic accepts this procedure.

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Dr. Katharina Oehler
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