A printed package leaflet can be dispensed with in future for medicinal products for use exclusively by healthcare professionals – a QR code on the packaging links directly to the Information for healthcare professionals.
01.12.2025
The implementation of the Dobler Motion 23.4183 makes it possible to dispense with a paper copy of the package leaflet for certain medicinal products.
Enclosure of the Information for healthcare professionals with medicinal products for which no Patient information is currently required can be dispensed with in future, provided that a two-dimensional barcode (e.g. QR code) giving direct access to the Information for healthcare professionals is placed on the outer packaging.
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. Other editorial changes have also been made as part of the update to the Guidance document.
The revised Guidance document is valid with effect from 1 December 2025.