On October 27, Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) issued Order No. 7939/2025, updating requirements for the authorization of business activities related to the manufacture, import, and distribution of cosmetics, personal hygiene products, and perfumes (collectively referred as cosmetic products).

This new regulation will repeal existing frameworks and is part of ANMAT’s ongoing efforts to modernize regulatory procedures and improve transparency and efficiency in the oversight of the cosmetics sector.

1. Submission of Declaration of Compliance
All applicable establishments must submit a Sworn Statement for Establishment Authorization via ANMAT’s digital platform. Once the declaration is submitted, a registration number will be issued, allowing the establishment to commence activities without prior approval.

Existing establishments previously authorized by ANMAT must file the declaration within 180 working days from the Order’s effective date.

Given that existing product packaging may still display previous authorization data, stock may remain on the market for up to three years from the date the new registration number is assigned.

The declaration will remain valid as long as the establishment continues operations. However, any modification to the submitted information must be reported through a new submission.

2. GMP (Good Manufacturing Practice) Requirements
Establishments are responsible for ensuring the quality, safety, and efficacy of their products, and they must comply with GMP requirements corresponding to their product category. For cosmetics, the GMP framework is defined under Order No. 6477/2012.