Questions and answers on mobile technologies
1 What additional information can be linked to using the QR code?
The additional information must relate to the safety, efficacy and/or quality of the medicinal product, must be justified on medical grounds, must be beneficial to the user and must accordingly be outlined concisely and succinctly.
Launch material and other advertising texts therefore cannot be linked to using the QR code. There should be no reference to the authorisation holder's website. The text must correspond to the Information for healthcare professionals and Information for patients or package leaflet. The information must be limited to what is essential; multiple mentions and repetitions or different formulations of the same information (rephrasing) are not permitted.
2 The URL/address of the website linked to the QR code is changing, but the content is not. What application type has to be submitted? New, 15 October 2025
For HMPs: The change should be reported as a type IAIN A.z. variation – Other regulatory changes.
(To be reported within 30 days)
For VMPs: The change should be reported as a Variation without assessment A.z. – Other administrative variation.
(To be reported within 60 days)
The procedure for HMPs and VMPs is: the authorisation holder should confirm in the Mobile technologies form that the content has not been modified in any way. The authorisation holder must also submit the updated packaging elements (medicinal product information and/or packaging) at the same time as the updated Mobile technologies form.
