New ANMAT regulation on simplified procedures for personal-use foods, donations, and compassionate use – ANMAT Disposition 3280/2025
Public Law Department Report | New ANMAT regulation on simplified procedures for personal-use foods, donations, and compassionate use – ANMAT Disposition 3280/2025
On May 19, 2025, on the Official Gazette it was published the Provision No. 3280/2025 (the “Provision”) issued by the National Administration of Drugs, Foods and Medical Devices (ANMAT), which formalizes the elimination of certain procedures related to the importation of food products under special regimes. This measure is part of the regulatory simplification and administrative efficiency process initiated by ANMAT Provision No. 537/2025.
1- Procedures excluded from ANMAT’s intervention
As for the entry into force of the Provision, which occurred on the date of its publication in the Official Gazette, ANMAT no longer intervenes in the following procedures:
– Request for authorization to import food products from donations.
– Request for authorization to import food products for personal use.
– Request for documentation regarding food products for specific medical purposes under compassionate use.
2- Prohibition on commercialization
The commercialization and/or use for profit of products covered by the aforementioned procedures is strictly prohibited.
We remain at your disposal to provide advice regarding the implementation of this new regulation and its impact on your economic activities. Please do not hesitate to contact us with any inquiries.
Best regards,