Mobile technologies – Submission of films as additional information regarding the safety, efficacy and quality of medicinal products

01.09.2024

The guidance document Mobile technologies stipulates the options for applying QR codes. The QR code can direct to a training/instructional film as additional information. In addition to the film script, the film can now also be uploaded directly via the portal with the application to apply a QR code.

The following document has been revised accordingly:

Form Mobile technologies, see section 5.2

The revised specification document is valid with effect from 1 September 2024.

The technical requirements for transmitting the films are outlined in the linked publication Submission of accompanying documentation for applications for authorisation and variation for human medicinal products.

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