01.01.2016 - In accordance with the publication
on the Swissmedic website dated 31 October 2015, and 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 that are approved. In response to various queries we have received, we should like to address specific aspects of this change in practice.
Communicating the Swissmedic decision on the notification via Swissmedic Portal
The applicant can implement a notified variation unless Swissmedic issues a decision to the contrary within 30 calendar days (CD) (post office franking mark on the decision) of receipt of the variation by the agency (date as per confirmation of receipt). In order to facilitate prompt implementation of variations requiring notification, as of 1 January 2016 (date of receipt of the variation) the Swissmedic Portal will not only announce the conclusion of variable notifications, as has been the case to date, but also make clear the actual Swissmedic decision (e.g. 'Approval' or 'Refusal'). If required, the applicant can then present a print-out of the portal entry to third parties as proof of the Swissmedic decision.
During a transitional period up to the end of March 2016, Swissmedic's decision on the notification will also appear on Swissmedic invoices.
Implementation date of the notified variation
Companies can implement notified variations from the date of the decision, i.e. they do not need to wait until 30 CD after confirmation of receipt if the decision has been announced to the applicant on the Swissmedic Portal on an earlier date.
However, time limits that follow on from the conclusion of a notification under Art. 11 TPO only start after the official 30 days from receipt of the notification by Swissmedic have elapsed. For example, the 30 CD period in which co-marketing authorisation holders must implement variations requiring notification that concern the basic product only starts 30 CD from the date of confirmation of receipt of the notification concerning the basic product, regardless of when Swissmedic's decision on the basic product applicant was communicated via the Swissmedic Portal.
Adaptation of a co-marketing medicinal product to ensure alignment with the basic product
The practice introduced on 31 October 2015 whereby co-marketing authorisation holders now have to submit a copy of the Swissmedic invoice instead of the copy of the approval letter for variations requiring notification under Annex 8 number 2 para. 1 number 6 of the Medicinal Products Licensing Ordinance (MPLO; SR 812.212.22) has proved to be too cumbersome in practice for companies. Therefore, a copy of the confirmation of receipt or a print-out of the relevant Swissmedic Portal entry should now be submitted instead of the copy of the invoice. The Variation requiring notification form has been amended accordingly.