Mexico's Pharmaceutical Regulations

Pharmaceuticals in Mexico are regulated by COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios).  In Mexico Pharmaceuticals are classified based on Mode of Preparation, Origin, and Mode of Delivery.

Document Number Document Title Issued by Description Available Languages Download
NOM-059-SSA1-2015 Good Manufacturing Practices of Medicines Ministry of Health The regulation lays down the minimum requirements necessary for the manufacturing process of medicines for human use marketed in Mexico and/or for research purposes. English For Sale
COFEPRIS-04-004-A SANITARY REGISTRY OF ALLOPATHIC MEDICINES, VACCINES AND HEMODERIVATIVES OF NATIONAL MANUFACTURE (NEW MOLECULE). COFEPRIS Information sheet on procedures related to sanitary registry, English For Sale
COFEPRIS-04-004-B SANITARY REGISTRY OF ALLOPATHIC MEDICINES, VACCINES AND HEMODERIVATIVES OF NATIONAL MANUFACTURE (NEW MOLECULE). COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-C SANITARY REGISTRATION OF ALLOPATHIC MEDICINES, VACCINES AND BLOOD PRODUCTS OF FOREIGN MANUFACTURE (NEW MOLECULE) COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-D SANITARY REGISTRATION OF ALLOPATHIC MEDICINES, VACCINES AND BLOOD PRODUCTS OF FOREIGN MANUFACTURE (GENERIC) COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-E SANITARY REGISTRATION OF INNOVATIVE BIOTECHNOLOGICAL MEDICINE OF NATIONAL MANUFACTURE COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-F SANITARY REGISTRATION OF INNOVATIVE BIOTECHNOLOGICAL DRUG OF FOREIGN MANUFACTURE COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-G SANITARY REGISTRATION OF NATIONALLY MANUFACTURED BIOTECHNOLOGICAL BIOCOMPARABLE DRUGS. COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-H SANITARY REGISTRATION OF BIOCOMPARABLE BIOTECHNOLOGICAL DRUG OF FOREIGN MANUFACTURE. COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-I SANITARY REGISTRATION OF A BIOLOGICAL PRODUCT WHOSE ACTIVE INGREDIENT IS REGISTERED IN A COUNTRY WITH AN EQUIVALENCE AGREEMENT WITH MEXICO COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-J SANITARY REGISTRATION OF A BIOTECHNOLOGICAL DRUG PRODUCT WHOSE ACTIVE INGREDRIENT WHOSE ACTIVE INGREDIENT IS REGISTERED IN A COUNTRY THAT HAS AN EQUIVALENCE AGREEMENT WITH MEXICO COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
COFEPRIS-04-004-K SANITARY REGISTRATION OF ALLOPATHIC PRODUCT WHOSE ACTIVE INGREDIENT IS REGISTERED IN A COUNTRY THAT HAS AN EQUIVALENCE AGREEMENT WITH MEXICO COFEPRIS Information sheet on procedures related to sanitary registry. English For Sale
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