A company is planning an Article 13 submission to Swissmedic based on several EU sequences for a known active pharmaceutical ingredient without innovation. The initial submission in the EU was made with a Drug Master File (DMF) from the API manufacturer. During the course of the life cycle, the API manufacturer switched to a Certificate of Suitability (CEP).
But what does this mean for the Article 13 submission in Switzerland? Does the original DMF have to be submitted, including all updates?
Swissmedic confirmed: If the reference approval to which the Article 13 TPA submission refers was initially made with a DMF and was later converted to a CEP, the DMF remains part of the reference dossier. For submission to Swissmedic, the DMF must be submitted in full – including the List of Questions (LoQ), the answers to the LoQ and the final Assessment Report (AR RP). The submission of the closed part of the DMF must be coordinated with the submission. The DMF form Part A, Part B and the letter of access must be prepared, as for a normal DMF submission.
