Switzerland: Mobile Technologies Guidance for Medicinal Product (QR Code)

ARQon
Jun 7, 2023
2 min read

Mobile technologies are accessible by anyone to search for information including people with disabilities. Mobile technologies come in various types and each one brings benefits into daily life, for example, QR Code. Swissmedic published guidance about the regulations on how to use mobile technologies (QR Code) and the regulations has come into effect on 1 March 2023. The published guidance is applicable for the authorization of human and veterinary medicinal products except for complementary medicinal products without indication under Art 39 of the TPLO.

The general principles required are information linked from the QR code must be valid and clear by the therapeutic products legislation. The QR code is not supposed to violate the safety of medicinal products and users’ devices. The authorized establishment should be aware that the QR code could be requested by the authority body as the new authorization procedures.

Next, the authorized establishment must apply languages that are required by therapeutic product legislation for the QR code. The authorized inspection by Swissmedic will only use the primary required language. While for hospital products, the language for the QR code should only in the official language or English only, according to Art 26 of TPO. However, it is allowable to add any additional languages as requested by demands.

Specific Requirements for QR Code

The authorized establishment must ensure the QR code complies with data protection regulations
The authorized establishment is responsible to apply the latest encryption standard between the hosting platform and end users
The authorized establishment shall guarantee the legibility, accessibility, integrity and availability of the linked data
The electronic text version presented must be identical to the approved text
Accessible hosting platform for Switzerland used

Any additional information inserted in the QR codes must be described properly and similarly to the approved version. The authorized establishment must submit the Mobile Technologies form for any alteration purposes for the QR code.