One of the fundamental documents to comply with the applicable regulations in Mexico for products regulated by COFEPRIS is the operating license. This document is submitted to COFEPRIS and is part of the essential documentation for any procedure, from sanitary registrations and queries to advertising authorizations.
The Operating License is a mandatory procedure established in the General Health Law (LGS) that individuals or legal entities must carry out before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) to announce the start of operations of a regulated establishment.
This notification informs the health authority about the activities, products, and/or services that will be carried out in the establishment, allowing COFEPRIS to exercise its sanitary control and surveillance functions.
The Operating License procedure offers different modalities tailored to specific needs:
New Operating License: For establishments initiating operations.
Modification of Operating License: Required for product changes, establishment information, or the designated sanitary responsible individual.
Data Update: Ensures the information on the operating license remains current.
Establishment Closure: Formal notification to COFEPRIS of the cessation of operations.
Applicants must provide comprehensive information about the establishment and its operations, including:
Identification data of the individual or legal entity.
Data of the Legal Representative.
North American Industry Classification System (SCIAN) code.
Information on authorized persons to carry out procedures.
Data on the person responsible for sanitation, if applicable.
Supporting documentation must accompany the application:
Notarized power of attorney of the Legal Representative.
Valid official identification of the legal representative's authorized personnel and sanitary responsible individual.
Professional license of the sanitary responsible person.
COFEPRIS has streamlined the process by implementing DIGIPRIS, a digital platform that facilitates efficient Operating License management. This tool empowers users to undertake the process independently, with immediate resolution.
Obtaining an operating license is a non-negotiable requirement for legal operations in Mexico and for conducting any procedures with COFEPRIS. Non-compliance can lead to administrative sanctions, including financial penalties and suspension of activities.
Recommendations:
Maintain an updated Operating License, reflecting any modifications to the establishment's operations.
Consult the COFEPRIS website and the Regulations of the General Health Law on Sanitary Control for detailed information regarding specific requirements for each activity.
Conclusion:
The Operating License is a crucial component of the health regulatory framework in Mexico. Compliance ensures legal operation and contributes significantly to safeguarding public health.
Written By:
Tania Ramírez
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