Good manufacturing practices for pharmaceuticals
Establishes minimum Good Manufacturing Practice (GMP) requirements for establishments engaged in the manufacture and/or import of human-use pharmaceuticals marketed in Mexico.
Last updated: 2024-08-15
Apply to COFEPRIS for product sanitary registration, presenting a complete technical dossier.
Obtain a Good Manufacturing Practices certificate from the manufacturing country certifying the production plant.
COFEPRIS may require a verification visit to the foreign manufacturing plant.
Adapt labeling to Mexican format with Spanish-language information, sanitary registration number, and importer data.
Process the import permit with COFEPRIS and present complete documentation for customs clearance.
Fines up to 400,000 UMA, merchandise seizure, sanitary registration suspension, and possible closure of the importing establishment.
Camtom helps you identify and comply with all applicable regulations for your imports.