MEXICO Trends and Developments Contributed by: Bernardo Martinez-Negrete, Lisandro Herrera Aguilar and Martha Contreras Secchi, Galicia Abogados, SC
tory authorities of the following countries: the United States of America, Canada, Japan, the United Kingdom, Brazil, Australia, the Republic of Korea, Singapore and Switzerland. In addi- tion to the above, commercialisation permits and marketing authorisations issued by the Europe- an Commission may be submitted. It is important to note that the above-mentioned commercialisation permits and marketing authorisations, issued by the regulatory authori- ties and used in the application of the 2024 Equivalence Agreement, must have undergone a thorough and independent review by the respec- tive regulatory bodies. This review process must meet the comprehensive standards set by the issuing authority to ensure that the product com- plies with the safety, efficacy and quality require- ments established in their jurisdiction. Only authorisations granted through the standard approval process can be used for the import per- mit request under the terms of the 2024 Equiva- lence Agreement. Specifically, authorisations that stem from alternative approval pathways – such as expedited or accelerated approval, conditional approval, emergency authorisation, court-ordered approval or any other non-stand- ard evaluation process – are not eligible for sub- mission under the 2024 Equivalence Agreement. Current application of the 2024 Equivalence Agreement for participating in consolidated public procurement The main purpose of the 2024 Equivalence Agreement is to facilitate the importation of cer- tain drugs and medical devices intended for the consolidated public procurement carried out by BIRMEX ( Laboratorio de Biológicos y Reactivos de México, SA de CV ), a state-owned company in charge of consolidating the entire purchase of several federal governmental entities, such as
the Ministry of the Navy ( Secretaría de Marina ), the Mexican Social Security Institute ( Instituto Mexicano del Seguro Social ), the Institute of Security and Social Services for State Workers ( Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado ), the Health Services of the Mexican Social Security Institute for Wel- fare ( Servicios de Salud del Instituto Mexicano del Seguro Social para el Bienestar ), national health institutes ( institutos nacionales de salud ), federal reference hospitals ( hospitales federales de referencia ) and other health service institu- tions integrated into the consolidated contract- ing process, in accordance with the applicable provisions. The consolidated contracting process is a form of centralised procurement that allows the Minis- try of Health and BIRMEX to consolidate the pur- chasing of health inputs such as drugs, medical devices and other essential supplies across vari- ous government health institutions. This system ensures that multiple organisations can access high-quality products through a co-ordinated and streamlined process. It also ensures that all products, regardless of the supplier, meet the required regulatory standards and are authorised by recognised authorities. How to participate in the procurement process through the 2024 Equivalence Agreement For foreign bidders to participate in the procure- ment process for drugs or medical devices with- out a marketing authorisation issued by COFE- PRIS, it is necessary to submit the following applications and comply with the requirements set forth below. Drugs Applications for import permits for drugs ( “COFE- PRIS-01-009-C sanitary permit for importation of
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