Comisión Federal para la Protección contra Riesgos Sanitarios
Mexican regulator; sets GMP for medicines through the official standard NOM-059-SSA1-2015.
WHAT COFEPRIS COVERS
The Comisión Federal para la Protección contra Riesgos Sanitarios regulates medicines, devices, food, and other health-risk products in Mexico, operating under the General Health Law and its regulations. GMP for human-use medicines is set by the official standard NOM-059-SSA1-2015.
WHERE IT SITS INTERNATIONALLY
COFEPRIS has been designated a WHO-Listed Authority and increasingly relies on evidence from PIC/S members and other recognised regulators, aligning its expectations with WHO GMP. For contract manufacturers and suppliers serving Mexico from abroad, that recognition policy is the single highest-leverage thing to understand: it determines whether market entry needs a Mexican inspection or an accepted foreign certificate.
HOW ITS REQUIREMENTS BITE
COFEPRIS issues sanitary registrations and licences and verifies GMP compliance through inspection of domestic and, where required, foreign sites. It has increasingly recognised GMP certificates from trusted foreign authorities — PIC/S members and WHO-Listed Authorities — as evidence, which shortens the path for sites already compliant elsewhere.
WHAT COFEPRIS PUBLISHES
- 01NOM-059-SSA1-2015 — Good Manufacturing Practices for medicines
- 02Other NOMs covering specific products, processes, and labelling
- 03Farmacopea de los Estados Unidos Mexicanos (FEUM)
- 04Sanitary registration requirements and guidance
- 05Health alerts and product safety notices
WHAT PRACTITIONERS GET WRONG
- ›NOM-059 is broadly WHO-GMP aligned, so a site running to EU or PIC/S standards maps closely — the differences are procedural and documentary rather than technical.
- ›Recognition of foreign GMP certificates can materially shorten registration — confirm the current recognition list before assuming a certificate will be accepted.
- ›Spanish-language documentation is expected, and the responsible-pharmacist role carries named personal accountability under Mexican law.
- ›Mexico is not a PIC/S participating authority, so reliance operates through COFEPRIS’s own recognition policy rather than through PIC/S mutual arrangements.
- ›NOMs are periodically revised and reissued under a new year suffix — cite the version in force, not the one your SOP was written against.
COFEPRIS STANDARDS SPEQ DECODES · 1
DISCIPLINES IN COFEPRIS’S REMIT
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