Recognition of Equivalent Requirements for Health Supplies and Import Criteria in Emergencies

On June 11, 2025, the Official Gazette of the Federation («DOF») published the agreement establishing the provisions for COFEPRIS to recognize decisions made by Regulatory Authorities…

COFEPRIS announces agreement on Recognition of Equivalent Requirements for Health Supplies and Import Criteria in Emergencies

On June 11, 2025, the agreement establishing the provisions for COFEPRIS to recognize decisions made by Reference Regulatory Authorities (“ARR”) and the WHO Prequalification Program in the health registration and life cycle of health supplies, as well as import mechanisms to address exclusively emerging diseases, neglected diseases, or national emergencies.

The provisions of this agreement are applicable to the following health supplies:

a) Medicines:

Classified as new molecules;

Generic;

Innovative biotechnology and

Biocomparable biotechnology.

b) Medical devices described in Article 262 of the General Health Law.

ARR authorizations must be recent (5 years for generics/biocomparables and 3 years for new/innovative molecules) and the drug must currently be marketed in the country of origin.

The agreement allows such products to be imported and marketed in Mexico under abbreviated regulatory pathways, provided that their quality, safety, efficacy, and performance are verified.

This agreement will enter into force 60 business days after its publication in the DOF.