1 July 2026

Swissmedic has amended the templates for the patient information and the information for healthcare professionals for human medicinal products. On the two redesigned websites www.swissmedicinfo.ch and www.swissmedicinfo-pro.ch, which offer barrier-free access to this product information, longer instructions for use at the end of the texts have become less visible, as they are collapsed by default under the tab "Stand der Informationen" (date of revision). To address this, Swissmedic has added an optional section "Gebrauchsanweisungen" (instructions for use) to both templates, intended only for extensive instructions for use or those containing figures that cannot be accommodated in the sections prescribed by the Ordinance of the Swiss Agency for Therapeutic Products of 9 November 2001 on the Licensing Requirements for Therapeutic Products (TPLRO).

Authorisation holders may revise the presentation of their texts using the updated templates and upload the revised versions via the "modify" function in SIMIS. This editorial change may be made independently, provided the content of the texts is not altered; where content changes are made, a corresponding application must be submitted. The updated templates must be used for new medicinal product information texts from 1 July 2026, and, for already authorised medicinal products, when applying for variations. The authorisation holder remains responsible for ensuring that the patient information and information for healthcare professionals are legible and user-friendly, and Swissmedic has requested that holders whose texts contain instructions for use at the end of the document update them using the new templates at the earliest opportunity.

For more information, see here.