To date, Swissmedic has always doubled the periods when companies applied for extensions and also granted a second extension without the need to justify this in a corresponding application. Swissmedic is now changing its practice on this issue and will no longer automatically grant a doubling of the original period for an initial extension.
The following will apply in future, for example, to new applications with a new active substance:
- For the "Reply to List of Questions" phase, the standard period remains unchanged at 90 calendar days. For the first extension, an additional period of 30 calendar days will now be granted (previously 90 calendar days). If this granted extension is also not observed, Swissmedic will assess the application based on the information at its disposal at the time of the LoQ and conclude the review without delay.
- For the "Reply to preliminary decision" phase, the standard period remains unchanged at 60 calendar days. For the first extension, an additional period of 20 calendar days will now be granted (previously: 60 calendar days). If this granted extension is also not observed, Swissmedic will assess the application based on the information at its disposal and issue a corresponding official decision.
A second extension will be granted only in justified exceptional cases. The application must include a valid, plausible rationale justifying the need for an extension.
This new ruling concerning extensions will take effect after its publication on 1 October 2020, following a transitional period of three months.