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Swissmedic: Digital Package Leaflet Instead of Paper

From 1 December 2025, medicines intended solely for use by healthcare professionals no longer require a printed package leaflet. Instead, a QR code on the outer packaging must provide direct access to the professional information.

The new rule is based on the existing Article 14 paragraph 2 of the Therapeutic Products Licensing Requirements Ordinance (TPLRO; SR 812.212.22) and is described in the Guidance document Packaging for human medicinal products.


Source:

Swissmedic: Authorisations/Information

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