On June 11, 2025, was published in the DOF the "AGREEMENT recognizing as equivalent the requirements established in the Health Regulation and the technical evaluation procedures carried out by the Federal Commission for the Protection against Sanitary Risks for the granting of the marketing authorization of health products, to the requirements, tests and evaluation procedures carried out by the regulatory authorities of reference to allow the sale, distribution and use of health products in their country, and to the evaluations of the World Health Organization's Prequalification Program, as well as the criteria for the importation of products for the treatment of emerging, unattended diseases or in cases of national emergency".
The Agreement establishes the criteria for the importation of products for the treatment of emerging and unattended diseases or in situations of national emergency. Among its provisions, it highlights that certain products such as vaccines, medicines and medical devices may be acquired by the Ministry of Health through the Strategic Fund and the Revolving Fund of the Pan American Health Organization (PAHO), without the need to have a marketing authorization in Mexico.
It should be recalled that this is not the first agreement of this nature, the last similar agreement was published in the DOF on December 4, 2024, "AGREEMENT to obtain the import permit for health products destined to guarantee the supply of the public sector", which allows obtaining more expedited import permits for products that already have a marketing authorization or sanitary registration issued by recognized regulatory authorities. (See our newsletter editions: SEP 19, 2024; FEB 2020; JUN 30, 2021).
In comparison, the new pathway through PAHO could represent an even more expeditious mechanism to try to "secure" the health sector's supply in priority cases than the one established by the agreement of December 4, 2024. In addition, this new agreement leaves without effect those previously published on March 29, 2019, January 28, 2020, and the June 22, 2021, amendment, although it does not repeal the December 4, 2024, agreement.
This new agreement does not define or specify the terms "emerging or neglected diseases or cases of national emergency", nor does it clearly establish the timeframe or the conditions for its application, which generates uncertainty regarding the scope and operability of the Agreement. Likewise, there is a possible affectation due to possible conditions of competitive disadvantage, discrimination and inequity to the suppliers of health products, due to the entry of products acquired from PAHO, at their discretion.
Thus, OLIVARES will continue to monitor the eventual implementation of these two agreements, in order to inform and advise our clients in a timely manner.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
