New regulatory framework for OTC products advertising

The Argentine Administration of Drugs, Foods, and Medical Technology (ANMAT) issued Regulation 4059/2025, published in the Official Gazette on June 12, 2025, to substitute the sanitary regulatory framework applicable to the advertising of over-the-counter products (OTC) by repealing ANMAT Regulation 4980/2005.

 

Unlike the former regulation, this new sanitary regulatory framework does not contemplate specific regulations for each product category. Instead, it only establishes general provisions applicable to all categories of OTC products.

 

This new Regulation applies to advertising addressed to the public, disseminated in traditional, non-traditional, and/or digital media, of the following products:

 

1. OTC medicines,
2. food products,
3. dietary supplements,
4. cosmetic products for personal hygiene and perfumes,
5. disposable hygienic products for external use and products for intravaginal use (new category included),
6. OTC household cleaning products classified as Risk I and II Type A and B,
7. OTC medical devices,
8. diagnostic products for in vitro use for self-testing.

 

The Regulation also redefines the concept of advertising as “(...) any form of communication or announcement whose purpose is to make a product, its characteristics, properties and/or uses known, in order to generate interest in the audiences and attract potential users.” In contrast with the previous regulation, this new wording expressly incorporates digital media as a form of communication of the advertising addressed to the public.

 

Moreover, the regulation establishes general principles that advertising directed to the public must comply with:

 

1. Only products that have obtained the corresponding authorization may be advertised.
2. Advertising must promote the adequate, safe and rational use of the product, objectively presenting its properties, characteristics, and uses without being deceiving or misleading; providing truthful, accurate, and clear information according to the information approved by the health authority.
3. Advertising must be placed in accessible and understandable language.
4. The owners of the products will be responsible for guaranteeing the proper use of the name, attributes, and/or messages disseminated in relation to the product, according to the specific characteristics of the media used for advertising.

 

In addition, advertising to the public must not (among others):

 

1. Include false, ambiguous, or exaggerated information that may be misleading about the properties or effects of the product.
2. Attribute therapeutic, nutritional, cosmetic, diagnostic, preventive or other actions or properties that have not been expressly authorized by the competent sanitary authority.
3. Disseminate messages that generate fear or distress, suggesting that a medicine is a food, cosmetic, or other consumer product, or that a non-medicinal product has a therapeutic effect.
4. Refer to experts, medical or scientific associations’ endorsement, or clinical trials if there is no documentation to support it.
5. Infringe the interests of public health.

 

The Resolution also modifies the definitions of “covert advertising,” “indirect advertising,” and “non-traditional advertising,”  and incorporates the definitions of “traditional (offline) media” and “digital (online) media.” Furthermore, it eliminates the definitions of “misleading advertising,” “subliminal advertising,” and “unfair advertising.”

 

Finally, infringements to this Regulation will make the marketing authorization holder of the product and the technical director—when applicable—liable for the penalties provided in Law 16463 on Medicines, Law 18284 Argentine Food Code, and the Decree 341/92.

 

This Regulation entered into force on June 13, 2025.