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
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.