After receipt of an application, Swissmedic checks the formal aspects of the application in the “Formal control and technical validation” phase. If the documentation for the application is complete and formally correct, the application is formally accepted as valid (“Doc. OK” milestone). If there are formal shortcomings in the application documentation, however, Swissmedic sends a formal objection to the applicant.
Previously, written notification of achieving the “Doc. OK” milestone was given for applications for human medicinal products if there had been a prior formal objection. In future, there will be no correspondence on achievement of the “Doc. OK” milestone.
Following a formal objection, the period stated in the guidance document Time limits for authorisation applications is available again to Swissmedic to recheck that the documentation is formally complete. After expiry of this time limit, the “Doc. OK” milestone is deemed to have been achieved. For applicants using the Swissmedic Portal, completion of the “Doc. OK” milestone will continue to be visible in the Swissmedic Portal.
The guidance document Time limits for authorisation applications has been amended accordingly and other formal aspects have been revised.
The new practice and the revised guidance document Time limits for authorisation applications come into effect on 1 September 2024.