Sanitary Alert: COFEPRIS mechanism against risky products
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS), through the Commission for Evidence and Risk Management (CEMAR), has a mechanism to publicize or warn the public about products that pose a risk for their use or consumption. This tool is the Sanitary Alert System (SAS).
The CEMAR as part of its responsibilities, is in charge of receiving national and international notifications regarding products or services that may represent a risk to consumer health. These notifications are carefully analyzed, and once the sanitary risk is confirmed, it is necessary to communicate it.
Through the SAS (Sanitary Alert System), COFEPRIS (Federal Commission for the Protection against Sanitary Risks) issues Sanitary Alerts, which are public documents that, as their name indicates, warn society about risks associated with the use or consumption of products or services and which require urgent safety measures.
Sanitary Alerts are disseminated through national media, as well as on the official COFEPRIS website. On the latter, the published alerts will be found organized according to the product or service category: medicines, medical devices, food supplements, deceptive advertising, etc.
Each alert will explain the reasons for its publication, which may include: illegal commercialization, counterfeiting, adulteration, contamination, misleading advertising of products, among others. Likewise, the name and brand of the product, the batch number, and the manufacturing date (if applicable) are specified for precise identification. Finally, relevant recommendations are made known to consumers and distributors in case they have acquired the alerted products.
The safety measures will be carried out and applied by both COFEPRIS and the State Commissions, and these will be focused on conducting sanitary verification visits for product seizure, suspension of establishments, as well as suspension of advertising, among others, which may also result in the imposition of fines.
Conclusion
The issuance of a Sanitary Alert, as mentioned, will focus on cases where specific irregularities of a product or service have been identified. However, this can be the starting point for the identification of other non-compliance issues in sanitary regulation, such as not having a Notice of Operation (Aviso de Funcionamiento), a Sanitary Registration (Registro Sanitario) (if applicable), a Good Manufacturing Practice Certificate, or the use of non-permitted ingredients, inadequate labeling, or the dissemination of deceptive product advertising.
Compliance with the regulations by all actors in the product distribution chain will be the central axis of operation, which not only safeguards consumer health but also functions as the main protection mechanism for companies, as it makes it possible to avoid any adverse event that could escalate into a sanitary crisis and lead to an Alert, which not only generates economic and operational losses but can also irreversibly damage the brand's reputation
Written by:
Mariel Antonio
About IPS
Regulatory compliance not only protects consumers, it also protects your company’s operations and reputation. At IPS, our team specializes in regulatory compliance, helping you strengthen your processes and prevent triggers within the Sanitary Alerts.
Contact us at info@insumosparasalud.com to learn how we can support your company in meeting regulatory requirements.