Timeframes for the Mexican health registration of certain medicines and health supplies are reduced

Timeframes for the Mexican health registration of certain medicines and health supplies are reduced

Yesterday the “Agreement establishing administrative measures to expedite the health registration procedure for medicines and other health supplies coming from abroad” was published in the Official Gazette of the Federation, under which the Federal Commission for the Protection against Health Risks (COFEPRIS) must resolve applications for the health registration of certain medicines and health supplies of foreign origin within a maximum term of 5 business days. In the event tha

Only medicines previously authorized by any of the following foreign health authorities shall be eligible: the Swiss Agency for Therapeutic Products-Swissmedic, the European Commission, the United States Food and Drug Administration, Health Canada, the Australian Therapeutic Goods Administration, and the PAHO/WHO Reference Regulatory Authorities. Also eligible are medicines prequalified by the World Health Organization Prequalification Programme for Medicines and Vaccines or by Regulatory Authorities that are members of the Pharmaceutical Inspection Co-operation Scheme. The only eligible health supplies are those that comply with various requirements implemented and administered by the United States Food and Drug Administration, Health Canada, and the Pharmaceuticals and Medical Devices Agency of Japan. The full agreement is available at this link. For additional information, please contact our experts: Luis Miguel Jiménez, Partner: +52 (55) 5258 1058 | lmjimenez@vwys.com.mx María de Lourdes Salazar y Vera, Associate: +52 (55) 5258 1058 | mlsalazar@vwys.com.mx

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news · September, 2026

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