In Mexico, advertising of products and services for human use or consumption is regulated by COFEPRIS and requires an authorization that can be a notice or a permit, depending on the type of product or service. Both procedures are carried out in order to guarantee compliance with the corresponding regulatory framework, avoid sanctions, and ensure responsible advertising.
In Mexico, advertising of products and services for human use and consumption is subject to a strict regulatory framework overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
The General Health Law (LGS) establishes that all advertising related to products and services for human use and consumption, such as medications, medical devices, and healthcare services, to name a few, requires prior authorization before its dissemination. This authorization will be processed before COFEPRIS and will apply to any type of advertising that refers to the existence, quality, characteristics, or promotes the use, sale, or consumption, either directly or indirectly, of the products and services specified in the Regulation of the General Health Law on Advertising Matters (RLGSMP).
The authorizations to which the advertising in question will be subject are the Advertising Notice or Permit, both of which aim to notify COFEPRIS about the advertising that is intended to be carried out and its characteristics. However, there are considerable differences between them, which are essential to know and understand in order to ensure compliance with the applicable regulations.
Advertising Notice:
Similar to the Operating Notice, the user will inform the health authority about the characteristics of the advertising to be disseminated and therefore compliance with the applicable regulations.
According to article 86 of the RLGSMP an Advertising Notice must be submitted for:
Health services provided individually.
Health supplies when addressed to health professionals.
Also, for the advertising of cosmetic products, an Advertising Notice must be submitted per brand (Art. 270 LGS and Art. 62 Bis RLGSMP).
Currently, this procedure is carried out digitally and free of charge through the DIGIPRIS platform, immediately obtaining the Advertising Notice number that must be included in the advertising material before its dissemination.
Advertising Permit:
One of the main differences is the way in which the procedure is submitted, as this is done in person through the COFEPRIS Integral Service Center (CIS). It is important to mention that another difference is the payment of fees that the person responsible for the advertising must make prior to submitting the process. This payment may vary according to the number of products and the advertising medium.
Obtaining the Advertising Permit will depend on the technical evaluation carried out on the advertising material, for which COFEPRIS has 10 business days to issue the corresponding authorization or denial.
This type of authorization is applicable for the advertising of:
Health services, except when they are services provided individually.
Alcoholic beverages.
Food supplements.
Medications and herbal remedies.
Health supplies, when addressed to the general population.
Beauty services and procedures.
Pesticides, plant nutrients (when they have toxic characteristics and toxic or dangerous substances).
Key Points to Consider:
Both the advertising notice and permit are processed for each means of dissemination. That is, a separate procedure is required for advertising on television, radio, social media, print, etc.
It is crucial that advertising is clear, truthful, and does not mislead the consumer.
Once the advertising authorization has been processed, the advertising of products and services continues to be subject to health surveillance.
Failure to comply with the regulations may result in financial penalties and the suspension of advertising.
Conclusion:
Understanding the difference between an advertising notice and permit is crucial for any person or company seeking to promote products or services in Mexico. Complying with the regulations not only avoids sanctions but also contributes to protecting the health of the population by ensuring that advertising is responsible and transparent.
Written By:
Mariel Antonio
about ips
If your company needs support in managing advertising notices and permits, you’ve come to the right place! At IPS, we have a team of experts in health regulation ready to guide you through the process and ensure that your advertising is clear and meets all legal requirements.
Contact us today at info@insumosparasalud.com for more information about our regulatory services.