ANMAT: New Requirements for Medicines Packaging

Regulation 2891/2026 of the Argentine Agency of Medicines, Food, and Medical Technology (ANMAT), published in the Official Gazette on May 15, 2026, establishes the mandatory incorporation of a two-dimensional code—QR or Data Matrix—on the secondary packaging of all medicines. This Regulation repeals ANMAT Regulation 3294/2025, which had limited this requirement to medicines of synthetic or semi-synthetic origin.

This measure aims to facilitate immediate access, through mobile devices, to the package leaflet approved by ANMAT and other information intended for patients and healthcare professionals. The code may coexist with the printed version of the leaflet, at the discretion of the marketing authorization holder.

The Regulation establishes six months for marketing authorization holders to generate the two-dimensional codes. Their physical incorporation into the packaging must be implemented progressively, taking into account the depletion of existing stock.

The codes must comply with international standards, such as GS1, to ensure interoperability and traceability. These codes must lead exclusively to the current ANMAT-approved leaflet and to information intended for patients and/or healthcare professionals. Any redirection to promotional content is expressly prohibited.

Finally, marketing authorization holders are responsible for the proper functioning of the codes and for the accuracy, updating, and continuous accessibility of the associated digital information.

This Regulation became enforceable on May 16, 2026.