Change in practice for variations requiring notification

No official decision letter if notification is approved.

31.10.2015 - In accordance with Art. 11, para. 2 of the Ordinance on Therapeutic Products of 17 October 2001 (TPO; SR 812.212.1), official decisions will no longer be issued for variations requiring notification received on and after 1 November 2015, provided that these variations are approved. The applicant can implement the variation unless Swissmedic issues a decision to the contrary within 30 days (post office franking mark on the decision) of receipt of the variation by the agency (date as per confirmation of receipt).
If the variation necessitates modification of the confirmation of authorisation (e.g. if pack sizes are discontinued), Swissmedic Portal users will only receive the updated version of the confirmation via the Portal. Non-Portal users will continue to receive their confirmation of authorisation by post.
If a notification contains shortcomings, the applicant will be sent an intermediate or official decision letter (as at present) and the variation may not be implemented.

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