What is the COFEPRIS?
The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) is a decentralized organ of the Department of Health with technical, administrative and operational autonomy, whose mission is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, which provides unity and homogeneity to the policies which are determined.
At the COFEPRIS, the scope previously attributed to sanitary regulation, control and promotion was enlarged and transformed from an instrumental policy into a public policy by objective; that is, it went from being a medium to becoming the social purpose of the latter, including other non regulative instruments, with the intention of preserving more efficiently the population’s health.
Scope of Competence
Sanitary regulation and promotion of the production, commercialization, import, export, publicity of, or involuntary exposure to:
PROTECT THE POPULATION AGAINST SANISTARY RISKS
ATTAIN A HEALTHY POPULATION PROPERLY PROTECTED AGAINST SANITARY RISKS
Properly protect the population
Cooperate to improve the companies’ competitiveness in order to insert them in foreign trade flow
Protect the national productive plant from disloayal competition
Duties, functions and characteristics that by law are attributed to the COFEPRIS
According to the General Health Law, the Department of Health will exercise sanitary regulation, control and promotion through the Federal Commission for the Protection against Sanitary Risks, for functions regarding (Art. 17 bis):
Control and supervision of health establishments.
Prevention and control of environmental factors which have harmful effects on man.
Basic occupational health and hygiene.
Sanitary control of products, services and their import and export, and establishments dedicated to processing the products.
Sanitary control of the process, use, maintenance, import, export, and final disposal of medical equipment, prosthetics, orthesis, functional aids, diagnostic agents, orthodontic goods and services, surgical and health materials, and of the establishments which process these products.
Sanitary control of the publicity of the activities, products and services.
Sanitary control of the disposal of organs, tissue and their components, human cells.
International public health system.
Sanitary control of organ, tissue, and human cell donation and transplant.
The COFEPRIS is a decentralized organ with administrative, technical and operational autonomy (Article 17 bis 1). It is headed by a Federal Commissioner designated by the President of Mexico, upon recommendation by the Minister of Health, since it is the Department of Health that supervises the COFEPRIS (Article 17 bis 2)
The Federal Commission is made up of eight administrative units and four government organs. The latter provide auxiliary consultation and advice for the COFEPRIS.
1. Evidence and Risk Management Commission
2. Sanitary Promotion Commission
3. Sanitary Authorization Commission
4. Sanitary Operation Commission
5. Analytic Control and Expansion of Coverage Commission
6. General Coordination of the Federal Sanitary System
7. Legal and Consultative Coordination Center
8. General Secretariat
1. Internal Council
2. Scientific Council
3. Mixed Consultative Council
4. Consultative Publicity Council