The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has implemented a series of simplification and modernization measures aimed at streamlining procedures and reducing the regulatory burden for establishments. These actions are part of the federal government’s regulatory improvement policies. This update specifically applies to the Operating License.
Update
On July 4, 2025, the “Agreement Establishing Simplification Measures for Procedures Carried Out Before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS)” was published in the Official Gazette of the Federation. The agreement outlines the elimination and consolidation of various procedures, as well as the establishment of updated requirements to reflect these adjustments.
Merger and Renaming of Procedures
As part of its effort to simplify the regulatory landscape, COFEPRIS has merged the “Operating License for Establishments Handling Products and Services” (Code COFEPRIS-05-018) and the “Notice of Modification or Cancellation of the Operating License for Establishments Handling Products and Services” (Code COFEPRIS-05-019).
The newly consolidated procedure will now be referred to as the “Operating License, Modification, or Closure of Establishments Handling Products and Services” and will retain the code: COFEPRIS-05-018.
Requirements
The main requirement for this procedure is the correct completion of the online submission form.
Regulatory Framework
Under the General Health Law, any company that does not require prior sanitary authorization must notify COFEPRIS of its activities by submitting an Operating License.
In this context, companies engaged in the manufacturing, marketing, or distribution of cosmetic products and dietary supplements are required to have an up-to-date Operating License.
This procedure is now fully digital, providing immediate resolution.
Effects from the RA update
As this is a digital procedure, the Operating License for Products and Services takes effect within 180 business days from the date of publication of the Agreement. This transitional period is intended to provide the necessary adjustments and updates to internal procedures and systems.
Written By:
Tania Ramírez
About ips
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