ANMAT Provision – No. 4033/2025
Health Department – Life Sciences Department Report | ANMAT Provision – No. 4033/2025
On June 10, 2025, Provision No. 4033/2025 (the “Provision”) was published in the Official Gazette, through which the National Administration of Medicines, Food and Medical Technology (the “ANMAT”) redefined the scope of its involvement in the procedures for import authorization requests for certain health products. The Provision introduces a simplified regime that replaces the prior authorization procedure with post-import declaration obligations, with the aim of optimizing resources and streamlining processes.
In this regard, the Provision establishes that ANMAT will not intervene in import authorization requests initiated by authorized establishments for the following groups of products: (i) cosmetics, (ii) household cleaning products, (iii) oral hygiene products for dental use, (iv) disposable hygienic products for external use, and (v) hygienic products for intravaginal use, whether for commercial purposes or free distribution. This exclusion also applies to procedures related to the importation of samples intended exclusively for exhibitions or commercial demonstrations, samples for testing laboratories, products received as donations, and raw materials intended for the industries of the aforementioned sectors.
In place of the prior authorization procedure, the Provision introduces the obligation to submit a “Notice of import” as a sworn statement. This notice must be submitted by importing establishments within 48 (forty-eight) hours of the products being nationalized, through the remote processing system (TAD) platform.
Finally, although the Provision eliminates the prior intervention of the agency, it maintains the requirement for full compliance with the health regulations applicable to each product category: Resolution (former MSyAS) No. 155/98, Resolution (former MSyAS) No. 708/98, Resolution (former MSyAS) No. 709/98, ANMAT Provision No. 692/2012, and Resolution (MS) No. 550/2022, among other complementary provisions.
This Provision will enter into force 30 days after its publication in the Official Gazette.
Sincerely,