The simplification of procedures for the application of the advertising permit for products and services, as well as for health supplies, and for the export support certificate procedures, has been published.
UPDATE
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) announced on April 28, 2025, an important update to the process for obtaining advertising permits. From now on, the procedures previously identified with the codes COFEPRIS-02-001-A and COFEPRIS-02-001-B will be consolidated into a single procedure called "Advertising Permit," which will have two modalities: one for products and services, and another for health supplies.
Under this new scheme, companies seeking to advertise dietary supplements, cosmetics, medical devices, as well as other categories of health products and supplies, must carry out the procedure under the new administrative simplification.
Furthermore, the published Agreement sets forth the requirements that must be submitted to process advertising permits under both modalities, which are as follows:
Proof of payment of applicable fees.
Advertising project.
Document supporting the advertising claims.
Advertising form FF-COFEPRIS-13.
Proof of legal representation, in accordance with the provisions of the Agreement.
Documentation related to the product that is not available in COFEPRIS's systems or electronic archives.
Moreover, the Agreement also provides for the unification of the procedures identified with the codes COFEPRIS-01-007-A and COFEPRIS-01-007-B into a single procedure entitled “Application for Export Support Certificate,” which will include two modalities: A, corresponding to “Free Sale,” and B, corresponding to “Export.”
These modalities apply to the following products: dietary supplements, cosmetics, alcoholic and non-alcoholic beverages, as well as hygiene and cleaning products that comply with current sanitary legislation and are either used and sold within the national territory (in the case of Free Sale) or manufactured in Mexico and exported to other countries.
Likewise, those interested in obtaining Export Support Certificates must carry out the procedure following the new provision, considering the following requirements:
Completed Authorization, Certificates, and Visits Form (FF-COFEPRIS-01).
Proof of payment of applicable fees.
Public instrument providing legal representation.
Product labels.
REGULATORY FRAMEWORK
This unification of procedures is part of the regulatory improvement actions promoted by COFEPRIS, aimed at streamlining administrative processes and facilitating regulatory compliance for companies. This provision is based on the current sanitary legislation in Mexico.
Effects from RA Update
In addition to the above, the simplification of the aforementioned procedures entails a reduction in processing times, which will be as follows:
For advertising permits, the resolution time will be reduced from 10 to 7 business days.
For export support certificates, the resolution time will be reduced from 5 to 3 business days.
The indicated modifications will enter into force 15 business days after their publication.
Written By:
Tania Ramírez
Mariel Antonio
Fernando Pérez
About ips
The recent regulatory update from COFEPRIS unifies and simplifies the procedures for obtaining advertising permits and export support certificates. To understand the new requirements in detail and ensure regulatory compliance in your processes, we invite you to contact us for specialized advice at info@insumosparasalud.com.