Swissmedic has extended the deadline for publishing officially mandated information materials on its electronic publication platform after identifying that the requirement had not yet been fully implemented for some medicinal products.
The new deadline is 31 December 2026.
The update was published on 12 November 2026 and applies to outstanding safety-related information materials that should already have been made electronically available in accordance with Swissmedic’s risk-management guidance.
What Is Required?
According to section 9.2.5 of Swissmedic’s Guidance document RMP / ICH E2E – Information for submission of RMP HMP, officially mandated information materials must be published electronically in all three official Swiss languages.
The objective is to ensure that healthcare professionals, patients and carers have continuous access to relevant safety information.
Original Transitional Deadline Was 1 November 2026
A transitional period had been established for information materials that were already in use before the relevant guidance entered into force.
That transitional period ended on 1 November 2026.
However, following spot checks, Swissmedic found that some companies had not yet completed the required publication activities.
Swissmedic Identifies Incomplete Implementation
Swissmedic states that its spot checks revealed that the publication obligation had not been fulfilled for some of the medicinal products concerned.
As a result, the authority has granted an additional period for compliance.
New Deadline: 31 December 2026
All outstanding officially mandated information materials must now be uploaded to the relevant electronic publication platform by 31 December 2026.
Companies should therefore review whether any required materials remain unpublished and complete the necessary uploads before the end of the year.
Different Platforms for Healthcare Professionals and Patients
Swissmedic distinguishes between information intended for healthcare professionals and information intended for patients or carers.
Materials for healthcare professionals must always be available on:
swissmedicinfo-pro.ch
Materials intended for patients and carers must be available on:
swissmedicinfo-pro.ch;
swissmedicinfo.ch.
Publication Must Cover All Three Official Swiss Languages
The requirement to publish in all three official Swiss languages is particularly important for compliance.
Companies should therefore ensure that the required information is available in:
German;
French;
Italian.
This is intended to provide broad and consistent access to risk-minimisation and other safety-related materials across Switzerland.
Link to Risk Management Plans
The publication obligation is connected to Swissmedic’s broader requirements around Risk Management Plans (RMPs)and risk-minimisation measures.
Officially mandated materials may form part of activities intended to communicate important safety information beyond the standard product information.
These materials can be particularly relevant where additional risk-minimisation measures are necessary to support safe use of a medicinal product.
Why the Extension Matters
The extended deadline gives marketing authorisation holders additional time to correct publication gaps.
However, the extension should not be interpreted as a relaxation of the underlying requirement.
Swissmedic explicitly states that all outstanding materials must be published by the new deadline in accordance with the applicable guidance.
Regulatory Supervision Will Continue
Swissmedic also makes clear that it may take regulatory action where the publication obligation is not respected.
As part of its supervisory activities, the authority reserves the right to:
investigate possible breaches;
assess non-compliance;
order regulatory measures where appropriate.
This makes the new deadline an important compliance milestone.
Impact on Marketing Authorisation Holders
Marketing authorisation holders should review their portfolios and confirm whether all officially mandated information materials have been correctly published.
Key actions include:
identifying medicinal products subject to mandated safety materials;
checking whether all required materials have been uploaded;
verifying availability in all three official Swiss languages;
confirming that the correct platform has been used;
ensuring content remains current and accessible.
Impact on Regulatory and Pharmacovigilance Teams
The update is particularly relevant for:
regulatory affairs;
pharmacovigilance;
risk management;
medical affairs;
local Swiss affiliates.
These teams should coordinate to ensure that required materials are available before 31 December 2026.
Importance of Publication Controls
The fact that Swissmedic identified gaps through spot checks highlights the importance of maintaining internal controls around publication obligations.
Companies may benefit from establishing:
publication trackers;
ownership matrices;
periodic compliance reviews;
language-version controls;
evidence of publication and update dates.
Patient and Healthcare Professional Access
The publication requirement is ultimately intended to ensure continuous access to important safety information.
For healthcare professionals, this supports appropriate prescribing, dispensing and patient management.
For patients and carers, access to dedicated safety information may improve understanding of:
important risks;
precautions;
monitoring requirements;
risk-minimisation measures.
Compliance Deadline Should Be Treated as Final
Swissmedic’s communication frames 31 December 2026 as the new deadline for all outstanding publications.
Given that the extension follows identification of incomplete implementation, companies should treat this as a priority compliance action rather than waiting until the end of the transitional period.
