What is COFEPRIS?
The Federal Commission for the Protection against Health Risks (COFEPRIS) is a key regulatory entity in Mexico, in charge of safeguarding public health through regulation, control, and promotion of health compliance in various sectors. Founded on July 5, 2001, COFEPRIS operates as a decentralized administrative body of the Ministry of Health, with technical, administrative and operational autonomy, which allows it to carry out its functions in a specialized manner and focused on the prevention of health risks..
Mission and Vision of COFEPRIS
The mission of COFEPRIS is to protect the health of the population through the regulation, control, health promotion and surveillance of establishments, products and services. This includes foods, beverages, medications, medical devices, among others, as well as the prevention and control of environmental factors that affect health. Its vision focuses on being an institution of excellence, recognized nationally and internationally for its contribution to public health.
Functions and responsibilities
COFEPRIS has a broad spectrum of responsibilities, including:
- Health regulation: Includes the issuance of standards and guidelines for the manufacture, import, export, distribution and sale of regulated products.
- Sanitary control: Monitoring the quality and safety of products and services, including food, non-alcoholic beverages, medications, and more.
- Authorization of establishments and products: Issuance of health licenses, health records and authorizations for the operation of establishments and the marketing of products.
- Health surveillance: Inspections and follow-up actions to ensure compliance with health regulations.
- Prevention of health risks: Initiatives and information campaigns aimed at the population on health risks.
Impact and Scope
COFEPRIS plays a crucial role in promoting public health and consumer safety in Mexico. Their work directly impacts the quality of life of the population, through the prevention of diseases and the promotion of safe and healthy environments. By regulating products and services that millions of people consume daily, it ensures that they meet established quality and safety standards, thus minimizing health risks.
COFEPRIS has gained international recognition as a reference regulatory authority in Latin America. Its ability to guarantee the safety and effectiveness of regulated products and services has strengthened confidence in the Mexican health system, both nationally and internationally.
How long does COFEPRIS take to approve a procedure?
The approval time of a process in COFEPRIS may vary depending on the type of request. Some procedures can be resolved in a few months, while others may take longer. It is advisable to consult specific times for each procedure directly with COFEPRIS or contact Grupo Briffault.
What is necessary to register a new medication with COFEPRIS?
To register a new medication with COFEPRIS, it is required to submit an application that includes detailed information on the composition, effectiveness and safety of the medication, clinical studies that support its use, as well as compliance with Good Manufacturing Practices (GMP).
How long does COFEPRIS take to grant a health registration?
The time to grant a health registration may vary depending on the type of product and the complexity of the file. In general, the process can take from a few months to a year, although COFEPRIS strives to expedite the procedures for priority products or products of interest to public health.
Is it necessary to renew health registrations for pharmaceutical products?
Yes, health records for pharmaceutical products must be renewed periodically with COFEPRIS. Renewal must be requested at least 6 months before the registration expiration date to ensure continuity in the marketing of the product.
What is needed to import products regulated by COFEPRIS?
To import products regulated by COFEPRIS, it is necessary to have a prior import permit, which is obtained by presenting documentation that certifies compliance with the health standards applicable to the product. This includes, among others, the health registration of the product in Mexico and the Good Manufacturing Practices certification of the country of origin.