Regulatory Update Agreement on Equivalence of Sanitary Registration and Importation Requirements for Health Supplies

In 2020, Mexico implemented an agreement allowing expedited importation and equivalence of certain health supplies approved by recognized international regulatory bodies, aiming to address shortages and streamline access. However, an update in September 2024 nullified this agreement, requiring full compliance with Mexican regulatory processes for all health supplies.

Update

On September 11th, 2024, an update to the “AGREEMENT recognizing as equivalent the requirements established in articles 161 Bis, 167, 169, 170 and 177 of the Health Supplies Regulation and the technical evaluation procedures carried out by the Federal Commission for the Protection against Sanitary Risks for the issuance of the sanitary registration of the health supplies referred to in articles 2, sections XIV, XV, subsections b and c and 166, sections I, II and III of the Health Supplies Regulation; in relation to articles 222 and 229 of the General Health Law, the requested requirements and evaluation procedures carried out; as well as the importation of medicines with or without health registration in Mexico, aimed at any disease or condition, which are authorized by the following regulatory authorities: Swiss Agency for Therapeutic Products-Swissmed, European Commission, Food and Drug Administration of the United States of America, Ministry of Health of Canada, Therapeutic Products Administration of Australia, PAHO/WHO Reference Regulatory Agencies; prequalified by the Prequalification Program for Medicines and Vaccines of the World Health Organization or Regulatory Agencies members of the Pharmaceutical Inspection Cooperation Scheme” . This update nullifies the previous allowances for equivalence and importation without sanitary registration, which were initially established in an agreement on January 28th, 2020.

The original agreement recognized the equivalence of technical evaluations and requirements between Mexico's regulatory body (COFEPRIS) and several international regulatory authorities. This facilitated faster access to essential medications, vaccines, and other health products, especially during shortages, by permitting importation without full Mexican sanitary registration if the product was already approved by a recognized agency.

Effects from the RA update

This change means that health supplies previously eligible for expedited importation now require full compliance with Mexican regulatory processes, including:

  1. Technical and scientific information

  2. Back-labels

  3. Good manufacturing practices certificate

  4. Production process certification

  5. Active ingredient certification

  6. Free sales certificate

  7. Technical evaluation process

  8. Laboratory tests

And also the importation of health supplies without sanitary registration which were previously authorized by the regulatory authorities such as Swiss Agency for Therapeutic Products-Swissmed, European Commission, Food and Drug Administration of the United States of America, Ministry of Health of Canada, Therapeutic Products Administration of Australia, PAHO/WHO Reference Regulatory Agencies; prequalified by the Prequalification Program for Medicines and Vaccines of the World Health Organization or Regulatory Agencies members of the Pharmaceutical Inspection Cooperation Scheme is no longer allowed.

The applications submitted during the period of validity of the agreement mentioned above will continue to be considered under the rules of the agreement

Written By:

Fernando Pérez

 

About ips

Our logistics team helps medical device manufacturers comply with regulatory requirements to import and commercialize their products in Mexico. Contact us if you are interested in learning how to import your products or any assessment about importation. We offer a wide range of services to meet your specific needs. Email us at info@insumosparasalud.com to learn more.