Also known as: GMP, BPM, Manufacturing best practices
A set of guidelines and procedures ensuring products are consistently manufactured under quality, hygiene, and safety standards appropriate for their intended use.
Good Manufacturing Practices (GMP) are guidelines ensuring products are consistently manufactured and controlled according to quality standards. In Mexico, GMPs are mandatory for pharmaceutical manufacturing (NOM-059-SSA1), food (NOM-251-SSA1), cosmetics, and medical devices. To import these products, foreign manufacturers must demonstrate equivalent GMP compliance, frequently through on-site audits or recognized certifications such as FDA (U.S.) or EMA (EU).
COFEPRIS Permit
An authorization issued by Mexico's Federal Commission for Protection Against Health Risks to import regulated products such as pharmaceuticals, medical devices, processed food, pesticides, and cosmetics.
RegulationsMexican Official Standard (NOM)
Mandatory technical regulation establishing requirements and specifications that products and services must meet in Mexico.
DocumentsHealth Import Certificate
A document issued by COFEPRIS authorizing the import of products that may affect human health, such as food, beverages, cosmetics, and medical devices.
RegulationsSanitary Requirement
A mandatory regulation establishing hygiene, food safety, and security conditions that imported products for human consumption or affecting public health must meet.