ANMAT Provision – N° 4059/2025
Healthcare- Life Sciences Department Report | ANMAT Provision – N° 4059/2025
On June 12, 2025, Provision No. 4059/2025 (the “Provision“) was published in the Official Gazette, through which the National Administration of Drugs, Food and Medical Technology (the “ANMAT“) comprehensively redefined the regime applicable to advertising aimed at the public of certain categories of health products. The regulation, which came into force on June 13, 2025, replaces the previous scheme and establishes updated guidelines for promotion in traditional, non-traditional and digital media.
The advance of information technologies and the appearance of new advertising formats prompted the need to update current regulations, to ensure truthful, clear and responsible advertising messages that protect public health. In this context, the new Provision expressly repeals ANMAT Provision No. 4980/2005 and Articles 3, 4, 5 and 6 of ANMAT Provision No. 7,730/2011, establishing a new regulatory framework.
However, although it formally repeals Provision 4980/2005, the new regulations generally retain the essence and guiding principles of the previous regime. The amendments introduced are mainly aimed at modernizing and expanding the scope of the framework applicable to the advertising of health products, adapting it to the challenges of digital media and new communication technologies. Among the main changes are a more precise definition of obligations and prohibitions for advertisers, the incorporation of specific concepts and categories linked to advertising in digital environments, and a strengthening of public health protection mechanisms against new advertising practices.
In summary, although the guidelines are updated and expanded, the fundamental objective of guaranteeing truthful, clear and responsible advertising – the central axis of the previous regime – remains fully in force under the new provision.
Below, we highlight the main aspects of the new regulations:
Scope of application: The Provision covers advertising aimed at the general public, disseminated in traditional, non-traditional and/or digital media, of the following products, whether domestic or imported: (i) over-the-counter medicinal specialties and over-the-counter herbal medicines; (ii) food products; (iii) dietary supplements; (iv) cosmetic products for personal hygiene and perfumes; (v) disposable hygiene products for external use and products for intravaginal use; (vi) over-the-counter household health products of Risk I and II Type A and B; (vii) medical products authorized as “non-prescription use”; and (viii) diagnostic products for in vitro use for self-evaluation.
General principles: The advertising of the products covered must comply with the following principles: (i) only products that have the corresponding sanitary authorization may be advertised; (ii) advertising must promote the adequate, safe and rational use of the product, objectively presenting its properties, characteristics and uses, without misleading or misleading; (iii) the information must be truthful, accurate and clear, and (iv) the language used must be accessible and understandable to the general public.
Formal requirements: All advertising intended for the public must include: (i) the commercial name and/or sales name of the product, as it appears in the registration or authorization; (ii) the display of the approved sign; (iii) the incorporation of specific health legends for each product category, ensuring their visibility or clear voice-over according to the advertising medium; (iv) the identification with respect to the different categories of products or combined products, if applicable. In addition, when applicable, it must include professional registration if recommendations from professionals are presented, and may incorporate a telephone number or website for consultations, provided that the information provided complies with regulatory requirements.
Prohibitions: Express prohibitions are established, such as: (i) spreading misleading, false, exaggerated or ambiguous messages; (ii) attributing properties, uses or actions not authorized by the health authority; (iii) suggest that a medicinal product is a food or cosmetic, or vice versa; (iv) disseminate messages that cause fear or anguish; (v) use the ANMAT logo or phrases that suggest endorsement or official certification; (vi) include approval messages from experts or associations without proper documentation; (vii) direct participation of children in the promotion of pediatric products; (viii) direct advertising exclusively or primarily to children without the accompaniment of an adult; and (ix) violating the interests of public health.
Definitions and scope: The Provision typifies and defines concepts such as covert advertising, indirect advertising and non-traditional advertising, covering the entire communication ecosystem, including the digital environment.
Sanctions: Violations of the Provision will make the owner of the product and, where appropriate, the technical director, subject to the sanctions provided for in Law No. 16,463 on the Import and Export of Medicines, Law No. 18,284 -Argentine Food Code- and Decree No. 341/1992 on the Unification of Sanctions for non-compliance with sanitary regulations, as amended or supplemented.
From its entry into force, all advertising campaigns for the products reached must be adapted to the newly established guidelines.
Sincerely,