The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements.
01.02.2026
The structure of the Guidance document has been fundamentally redesigned to ensure a better overview and readability.
Major changes to content have also been made in the following sections:
In section 5.1 General requirements, the start and end of the reporting obligation have been defined more clearly and stated more precisely.
The former section 7 has been restructured into section 5.3 Signals from authorities and the information has been clarified. For signals from authorities, there is no reporting obligation for marketing authorisation holders (MAH) of KAS without innovation, biosimilars and co-marketing medicinal products who adapt the medicinal product information by conformation. The opening report is not required for signals from authorities without serious risk potential. In addition, Day 0 has been redefined for signals and outcomes from EMA PSUR/PSUSA procedures. The time limit for signals from authorities without serious risk potential has been extended from 30 to 90 days.
The former section 10 has been renumbered as section 5.4 Formal requirements for signal reporting. Redundant content on signal correspondence has been deleted. Applications to change the medicinal product information should no longer be submitted at the same time as the signal report as in future, risk-minimisation measures from signals from authorities will be implemented entirely within the scope of the signal evaluation procedure. An additional information requirement via e-mail for emerging safety issues has also been added.
A new section on Signal evaluation procedures has been added as section 5.5. If Swissmedic considers measures to be appropriate and/or requires additional information based on the results of the signal evaluation procedure, it will contact the MAH at the latest six months after the signal conclusion report. If the MAH does not suggest any measures and Swissmedic agrees with this approach, as previously, there will be no further correspondence. In this case, the MAH can assume Swissmedic’s consent after six months.
MAHs of KAS with innovation are obliged to implement the adaptation of the medicinal product information as part of the signal evaluation procedure (conformation is not possible).
The publication deadline for the updated medicinal product information texts is now linked to the completion of the Type IAIN application and is set at the latest at 20 days thereafter.
A new section on Publication “Safety Update – Information for healthcare professionals updates” has been added as section 5.7.
A new section 7 Annexes has also been added, which contains diagrams of the reporting obligations for company signals, signals from authorities and PSUR/PSUSA outcomes.
Other editorial changes and clarifications of content have also been made in all sections.
The revised Guidance document is valid with effect from 1 February 2026.
The Signal Notification Form has also been revised accordingly and also comes into effect from 1 February 2026. The form has been transferred to a new layout and clarified in line with the requirements in version 10 of the Guidance document Drug Safety Signals HMP.