Missing documentation on the Restricted Part of the Drug Master File (DMF) in the context of Art. 13 TPA applications


Swissmedic has found that in applications submitted under Art. 13 TAP the DMF holders have not provided complete documentation on the Restricted Part of the DMF. In particular, the Assessment Report of the Restricted Part, the List of Questions and the company's answers to the Restricted Part are missing.

The following documents have been updated to reflect changes in practice:

Swissmedic advises the applicant to explicitly draw the DMF Holder's attention to this point so as to avoid any delays in processing the application.

The new versions of the affected documents enter into force immediately. The previous versions of the checklists for formal control will continue to be accepted during a transitional period lasting until 1 February 2016.