Safety signals for human medicinal products: change in the safety signal process following modification of medicinal product information as a risk minimisation measure, effective 1.01.2020
As a new feature of the safety signal process, official decisions on the final wording for modified medicinal product information and/or packaging are already being issued after the signal has been evaluated. This means that once an official decision has been issued, marketing authorisation holders can submit the variation to Swissmedic within 30 calendar days as a C.I.1 a) type IAIN application. Please note, however, that these applications for a variation cannot be submitted as part of a multiple application.
Modifying the safety signal process means that variations can be implemented faster.
The process in detail:
If medicinal product information has to be modified in the course of Swissmedic's evaluation of a signal, marketing authorisation holders will be sent the wording of the modified text by letter.
They will then have an opportunity to comment on the measures and the wording of the modification.
Unless marketing authorisation holders inform Swissmedic otherwise within the specified deadline, the Agency will assume that they consent. It will then issue its official decision on the text and complete the signal with that decision.
If marketing authorisation holders do inform Swissmedic otherwise, the Agency will review their reply and notify them of its decision by means of a preliminary decision.
Once the official decision on the wording has been issued, the modified medicinal product information and/or packaging texts must be submitted as a C.I.1 a) type IAIN application.
Swissmedic can propose a general wording when extensive and complex modifications are required. In such cases, marketing authorisation holders should submit the final text plus their own comments as they deem necessary. After reviewing the proposed text, Swissmedic will notify marketing authorisation holders of the outcome of its review, including any text corrections, in the form of a preliminary decision.
An official decision on the final text will be issued once marketing authorisation holders have replied to the preliminary decision. A C.I.1 a) type IAIN application should then be submitted within the specified deadline.
Section 11 of guidance document MU101_20_001e_WL Guidance document Drug Safety Signals HMV4 will be updated accordingly.
The new safety signal process will apply from 1 January 2020.