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:
Mission
PROTECT THE POPULATION AGAINST SANISTARY RISKS
Vision
ATTAIN A HEALTHY POPULATION PROPERLY PROTECTED AGAINST
SANITARY RISKS
Objectives
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)
Organizational Structure
The Federal Commission is made up of eight administrative
units and four government organs. The latter provide auxiliary consultation and
advice for the COFEPRIS.
Administrative Units:
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
Government Organs:
1. Internal Council
2. Scientific Council
3. Mixed Consultative Council
4. Consultative Publicity Council
