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COFEPRIS

The decentralized body of Mexico’s Ministry of Health responsible for health regulation, control and oversight. Its authorizations must be available as evidence; some, including health registrations, expire.

RegulatoryFederal Commission for Protection against Health Risks

The decentralized body of Mexico’s Ministry of Health that regulates, controls and oversees products and facilities posing health risks: medicines, medical devices, food, supplements, cosmetics and the facilities where they are made or stored.

The records it generates

Health registrations, licenses, permits, operating notices and supporting technical records. Under the law’s general rule, health authorizations have an indefinite term; health registration is the exception, lasting five years and renewable at the holder’s request. All remain subject to physical or documentary verification, which the law permits without prior notice; the written order is delivered when the visit begins.

Where it matters

At renewal. A health registration not renewed on time can be canceled by the authority, preventing the product from being sold or supplied. Teams working under this authority need visible dates to avoid losing market access.

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