According to section 9.2.5 of the Guidance document RMP ICH E2E information submission HMP, officially mandated information materials must be published on the electronic publication platform in all three official Swiss languages in order to ensure that healthcare professionals and patients have access to this safety-related information at all times. A transitional period ending on 1 November 2026 applied to the publication of officially mandated information materials that had been implemented before the guidance document came into force.
After conducting spot checks, Swissmedic discovered that this obligation has not yet been fulfilled for some of the medicinal products concerned.
Swissmedic has therefore extended the deadline to 31 December 2026. By this date, all officially mandated information materials that have not yet been published must be uploaded to the electronic publication platform in accordance with the requirements of the guidance document.
Officially mandated information materials for healthcare professionals must always be available on www.swissmedicinfo-pro.ch, while those for patients and carers must be available on www.swissmedicinfo-pro.ch and www.swissmedicinfo.ch.
As part of its supervisory activities, Swissmedic reserves the right to investigate breaches of the above-mentioned requirements and, where appropriate, order regulatory measures.
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