Simplified Procedures for Health Regulations: COFEPRIS charges more than 30 procedures.

July 14, 2025

On July 11, 2025, the Secretary of Health published a General Agreement in the Official Gazette of the Federation establishing simplified administrative procedures that are managed by the Federal Commission for the Protection against Health Risks (COFEPRIS). This comes in response to the principles of efficiency, transparency, and continuous improvement established in the General Law of Regulatory Improvement and represents a structural change in how individuals and legal entities will interact with the health authority.

The primary purpose of the Agreement is to reduce administrative workloads, optimize response times, and modernize regulatory management without compromising health safety standards. To this end, measures will be implemented ranging from the merging of procedures to the elimination of physical documentation requirements, including the creation of new formats for immediate resolution and transforming certain procedures into notices or reports.

Among the most relevant changes is the merging of procedures with similar purposes, which would allow for quicker and less fragmented management. For example, procedures related to modifying the health licenses of health establishments have been consolidated under a single unique code, with different modalities according to the type of modification (administrative or technical).

Likewise, new formats of immediate resolution were introduced in which COFEPRIS will issue a corresponding certificate once the payment of rights is validated and compliance with the minimum requirements is met. This measure applies to procedures modifying the health registration of medical devices, pesticides, plant nutrients, as well as health licenses for establishments, among others.

Another innovative feature is the conversion of procedures into notices or reports, which means prior authorization is no longer required to begin certain activities. Such is the case for the annual reports of chemical precursors, which will now be an immediate notice, or the revocation of health registrations, which will convert to a notice of deregistration.

The Agreement also establishes a reduction in resolution times for procedures that had previously required a time limit of up to 30 business days, but now must be resolved in a maximum of 15 days. This measure seeks to provide greater legal certainty for regulated entities and promote competitiveness in the sector.

In line with the digitalization of public services, the necessity to present physical documentation for various procedures has been eliminated, provided that the corresponding information was captured in official formats, whether online or on paper. In addition, the catalogue of procedures has been streamlined by eliminating obsolete and redundant procedures.

At A&L, we believe that this Agreement represents a strategic opportunity for organizations in the health sector to review their internal procedures, update their formats, and train personnel responsible for regulatory management. Correct implementation of these measures can translate into operational savings, greater speed in decision-making, and a better relationship with the health authority.

Our legal and regulatory team is available to provide specialized advice, prepare a compliance assessment, aid in the transition to the new formats, and represent your organization before COFEPRIS in this new phase of simplified regulatory procedures.