Patient information and Information for healthcare professionals for human medicinal products: Change to the templates

The two redesigned websites www.swissmedicinfo.ch and www.swissmedicinfo-pro.ch offer barrier-free access to Patient information and Information for healthcare professionals, respectively. The new design means that longer instructions for use at the end of the Patient information and Information for healthcare professionals are less visible, as they are collapsed under the tab “Stand der Informationen” (date of revision of the text) as standard.

Swissmedic has therefore added an optional section “Gebrauchsanweisungen” (instructions for use) to both the Patient information and Information for healthcare professionals for human medicinal products templates. This option is only intended for extensive instructions for use or those with figures, which cannot be incorporated in the sections specified in the TPLRO. Authorisation holders can revise the presentation of their Patient information or Information for healthcare professionals using the updated templates and then upload the revised Patient information or Information for healthcare professionals via the “Modify” function in SIMIS. This editorial change can be made independently unless changes have been made to the content of the texts. In these cases, an appropriate application must be submitted.

The updated Patient information and Information for healthcare professionals for human medicinal products templates must be used from 1 July 2026 for new medicinal product information texts. In the case of medicinal products that have already been authorised, they should be used when applying for variations. The authorisation holder is responsible for ensuring the Patient information and Information for healthcare professionals are readable and user-friendly. Swissmedic requests authorisation holders for medicinal products whose Patient information and/or Information for healthcare professionals include instructions for use at the end of the document to update the relevant texts using the new templates at the earliest opportunity.