Argentina Introduces Revised Authorization Framework for Cosmetic Establishments

On October 27, 2025, Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) issued Order No. 7939/2025, introducing updated requirements for the authorization of business activities for establishments engaged in the manufacture, import, and distribution of various products, including cosmetics, personal hygiene products, and perfumes (collectively referred to as "cosmetic products"). The Order will take effect 60 working days after its issuance.¹

Order No. 7939/2025 is scheduled to repeal existing regulations governing the authorization of establishments, including Order No. 1109/99 for cosmetic establishments. Compared with the previous framework, the new Order streamlines the authorization process by transitioning to a declaration-based system, while maintaining strict adherence to Good Manufacturing Practice (GMP) requirements. In line with this shift, establishments are required to fulfill the following obligations:

1. Submission of Declaration of Compliance

All applicable establishments are required to submit a Sworn Statement for Establishment Authorization via ANMAT's designated digital platform. Upon submission, a registration number will be automatically assigned, allowing establishments to commence operations without prior approval, while remaining subject to subsequent verification by ANMAT.

Existing establishments previously authorized by ANMAT shall submit the declaration within 180 working days from the Order's effective date. Considering that product packaging may contain prior authorization information, stocks with such packaging may remain on the market for up to three years from the assignment of the new registration number.

The declaration remains valid as long as the establishment continues its business activities. Any modification to the information contained in the declaration shall be reported through a new submission within 30 days, which will replace the original declaration.

2. Adherence to GMP Requirements

Establishments bear primary responsibility for ensuring the quality, safety, and efficacy of their products. Accordingly, all applicable establishments shall comply with GMP requirements relevant to their product category.

For cosmetic establishments, the applicable GMP standards are established under Order No. 6477/2012, which sets detailed requirements for manufacturing practices, hygiene, quality control, personnel qualifications, and documentation procedures.

Companies are required to maintain all necessary documentation to prove GMP compliance and will be subject to regular inspections by ANMAT to verify adherence to these standards.