Amendment to the Regulations on Health Supplies

Amendment to the Regulations on Health Supplies

May, 2026

On April 24, 2026, an amendment to the Regulations on Health Supplies (Reglamento de Insumos para la Salud) was published in the Official Gazette of the Federation, entering into force on the day following its publication.

This amendment introduces structural changes to the regime governing marketing authorizations (sanitary registrations) and strengthens various mechanisms for the protection of intellectual property and pharmaceutical innovation. The main points are highlighted below: 1. “New Molecule” is redefined as any drug, biopharmaceutical, or substance with therapeutic, preventive, or rehabilitative activity that does not hold a sanitary registration in Mexico. Consequently, the absence of registration becomes the governing criterion for qualifying as a new molecule. 2. The role of the New Molecules Committee is limited by eliminating the prior technical meeting with the applicant, with the Committee’s opinion now being incorporated within the sanitary registration evaluation process. In addition, where prior authorization from a recognized foreign authority exists, such opinion will only be required if associated risks are identified, which expedites the procedure in certain cases. 3. The patent linkage mechanism is strengthened by aligning it with current legislation and with the listings of the Mexican Institute of Industrial Property (IMPI). Additional requirements are incorporated to evidence ownership or licenses and, in the case of generics and biocomparables, it is permitted to declare non-infringement of patents, with the authority being empowered to request a technical opinion from IMPI. 4. Compensation is introduced for unreasonable delays attributable to the authority in granting the sanitary registration of allopathic medicines; where such delays affect the effective period of exclusivity of a patent previously identified in the application, the holder may request an adjustment to the term of one of the medicine’s patents by means of a supplementary certificate, which may not exceed 5 years. 5. As regards the protection of test data, a 5-year exclusivity period is established for the technical and scientific information relating to safety, quality, and efficacy submitted to obtain the sanitary registration of medicines containing new molecules. During that period, such information may not be used by third parties without the holder’s consent, which directly affects the market entry of generics. 6. The term of extensions of sanitary registrations is expanded to align them with the General Health Law, establishing a first extension that increases from 5 to 10 years and subsequent renewals, generally, also for periods of 10 years. The amendment seeks to reduce regulatory uncertainty, strengthen the protection of innovation, and align Mexico with international standards. The adjustments to patent linkage and regulatory compliance stand out. However, it will be necessary to review its scope in each particular case and, where appropriate, to make strategic adjustments to regulatory and industrial property planning. For additional information, please contact: Luis Miguel Jiménez, Partner:+52 (55) 5258-1054 | lmjimenez@vwys.com.mx Patricia Kaim, Partner:+52 (55) 5258-1013 | pkaim@vwys.com.mx Lourdes Salazar, Counsel:+52 (55) 5258-1058 | mlsalazar@vwys.com.mx Ileana Pantiga, Associate:+52 (55) 5258-1058 | ipantiga@vwys.com.mx Julián Luna, Associate:+52 (55) 5258-1000 | jluna@vwys.com.mx Fernando Mancilla, Associate:+52 (55) 5258-1054 | fmancilla@vwys.com.mx Adrián Martínez, Associate:+52 (55) 5258-1038 | admartinez@vwys.com.mx

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