What is the COFEPRIS Operation Notice for?
The Notice of Operation before the COFEPRIS (Federal Commission for the Protection against Sanitary Risks) in Mexico It is an administrative document that informs the health authority about the start of operations of establishments dedicated to activities related to products and services that may have an impact on public health. These activities include the manufacture, import, storage, distribution and sale of food, medicines, medical devices, cosmetics, personal hygiene products, and other goods and services subject to health regulation.
The purpose of the Operation Notice is multiple:
- Regulation and Surveillance: Facilitates COFEPRIS' task of regulating and monitoring establishments to ensure that they operate in accordance with current health standards, thus protecting the health of the population.
- Transparency and Control: Provides an official record of establishments that carry out activities regulated by COFEPRIS, allowing more effective control over them and ensuring that they comply with applicable regulations.
- Prevention of Health Risks: By requiring compliance with certain standards for operation, the notice helps prevent health risks associated with the products and services offered by establishments.
- Operational Legitimacy: Provides establishments with proof that they have notified the health authority about their operation, which is a legal requirement for their operation.
- Basis for Inspections and Audits: Serves as a starting point for health inspections and audits by COFEPRIS, ensuring that facilities and operations are safe and in compliance with legislation.