Changes in importation of health products coming from abroad.

September 19, 2024

On September 11, an AGREEMENT was published in the Official Gazette of the Federation that leaves without provisions that allowed the importation of health products (medicines and medical devices) WITHOUT marketing authorization of the Equivalence Decree published back on January 28, 2020, in the Federal Official Gazette by the Ministry of Health [Newsletter FEB 2020] and its respective modification, published on June 22, 2021. [Newsletter JUNE 30, 2021],

As of September 12, the provisions that allowed the possibility of importing health products (medicines and medical devices) without marketing authorization and indicated the requirements to materialize such importation ceased to have effect.

The decree and the technical annex through which the importation of health products without MA was allowed indicated the possibility of obtaining a MA for the imported product through a similar process to the one stated in the Health Law Regulations, but in a much shorter period than the one provided in the regulations, considering that the requirements had been met through equivalence. In this sense and regarding the procedures initiated prior to this latest agreement of September 11, 2024, the prosecution of the applications will continue their course based on the corresponding provisions.

Likewise, the 2020 agreement and its modification opened the way for the participation of companies in public tenders to offer products without marketing authorization that covered a certain “need” in the sector. Since the effects of these provisions have ceased, it will no longer be possible to participate in public tenders without a marketing authorization, so there will undoubtedly be a positive impact on the development of the procurement process for health products.

At OLIVARES, we will continue to monitor the implementation of this agreement to guide our clients and the industry under best practice strategies.