ANMAT Provision – No. 2891/2026
Healthcare & Life Sciences Department Report |ANMAT Provision – No. 2891/2026.
Dear all,
On May 14, 2026, Provision No. 2891/2026 (the “Provision“) was published in the Official Gazette, through which the National Administration of Medicines, Food and Medical Devices (“ANMAT“), established a new regime for the mandatory inclusion of bidimensional codes —QR or Data Matrix— on the packaging of all medicines, regardless of their origin and conditions of sale.
The Provision repeals ANMAT Provision No. 3294/2025, which had introduced this requirement exclusively for medicines of synthetic or semi-synthetic origin, with the aim of updating and expanding its scope in accordance with technological advances and international standards.
In this sense, the Provision expands and updates the previous regime in the following aspects:
-Extended scope: the obligation to include a bidimensional code —printed or affixed as a label with anti-fraud technology— on the secondary packaging (and optionally on the primary packaging) extends to all medicines, without distinction of origin (synthetic, semi-synthetic, biological, etc.) or conditions of sale.
-Technology: both QR codes and Data Matrix codes are accepted, which must be generated in accordance with international standards —such as GS1— to ensure uniqueness, interoperability, and traceability.
-Placement: As before, the code must be placed on the packaging under conditions that ensure its correct display and reading, with appropriate size and contrast.
-Responsibility of registration holders: unlike the previous regime —in which the code was provided by ANMAT—, the Provision establishes that registration holders are responsible for the correct generation and functioning of the code, for the accuracy, updating, and availability of the linked information, and for the continuous accessibility of the digital content.
-Code content: the code must link exclusively to the current prospectus approved by ANMAT and to the information intended for the patient and/or healthcare professional, allowing access to information updated in real time. Redirection to promotional or advertising content is expressly prohibited.
-Repository: the information must be hosted in a repository defined by the registration holder, under its sole responsibility.
-Implementation deadlines: a period of six (6) months from entry into force is established for the generation of all bidimensional codes by the registration holders. The physical implementation on packaging must be carried out progressively, in accordance with an adaptation schedule that considers the depletion of existing stock, without the regulation establishing a specific deadline for this purpose.
-Coexistence with printed prospectus: the bidimensional code may coexist with the printed version of the prospectus, if the holder chooses to maintain it.
The Provision entered into force on May 15, 2026, the day following its publication in the Official Gazette.
Sincerely,