ANMAT Provision – No. 3294/2025
Healthcare & Life Sciences Department Report | ANMAT Provision – No. 3294/2025.
Dear all,
On May 19, 2025, Provision No. 3294/2025 (the “Provision“) was published in the Official Gazette, through which the National Administration of Medicines, Food and Medical Technology (the “ANMAT“), established the mandatory inclusion of a QR code in the secondary packaging – and optionally in the primary packaging – of medicines of synthetic or semi-synthetic origin. This measure aims to facilitate immediate access to up-to-date information on the medicines´ prospectuses, through mobile devices, thus improving accuracy and avoiding the circulation of outdated information.
In this sense, the Provision introduces the requirement to include a printed or affixed QR code (with anti-fraud technology), in an appropriate size and position to ensure its correct display, on the secondary packaging of all medicines of synthetic or semi-synthetic origin, in all their conditions of sale. This QR code may coexist with the traditional printed prospectuses, and information for the patient may be included in digital form.
This requirement will be mandatory for all products reached from one year after the entry into force of the Provision.
It should be noted that the Provision establishes that the QR code will be provided by the Directorate of Clinical Research and Management of the Drug Registry of the National Institute of Medicines. To do this, the request for the incorporation of the QR code must be initiated with said Directorate, in accordance with the following:
1-New products: must be done after registration in the Electronic Management System with Digital Signature for the Application for Registration in the Registry of Medicinal Specialties (REM) and before the application for effective marketing authorization.
2-Products already registered and authorized at the time of the entry into force of the Provision: within the period of one year established for implementation.
If modifications need to be made to the prospectuses after a QR code has been assigned, the changes will be processed through the usual procedure called “Modification of labels and prospectuses and information for the patient” and once authorized they will be uploaded to the assigned QR code.
The Provision enters into force upon its publication in the Official Gazette.
Sincerely,