Mexico's Health Authority ( COFEPRIS)
COFEPRIS or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios is a decentralized and autonomous body run by a commissioner appointed by the President of Mexico and regulates health facilities, advertising activities, and the manufacturing, import, or export of health products.
Good Manufacturing Practices (GMP)
| Document Number | Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|---|
| - | Health Supplies Regulation | United States of Mexico Secretary of Health | The purpose of this Standard is to regulate the sanitary control of herbal remedies and supplies, as well as that of the Establishments, activities and services related to them. | English | For Sale |
| NOM-059-SSA1-2015 | Good Manufacturing Practices of Medicines | United States of Mexico Secretary 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 |
| NOM-241-SSA1-2012 | Good Manufacturing Practices for establishments dedicated to the manufacture of Medical Devices | United States of Mexico Secretary of Health | The regulation lays down the requirements that processes must meet, from the design of the installation, development, obtaining, preparation, mixing, production, assembly, handling, packaging, conditioning, stability, analysis, control, storage and distribution of medical devices marketed in Mexico. | English | For Sale |