Date: September 2, 2026
Mexico’s Ministry of Health – COFEPRIS – has published new guidelines opening an ANVISA equivalence pathway: a shortened registration route in which COFEPRIS accepts the requirements, tests and evaluation procedures already applied by Brazil’s ANVISA as equivalent to its own when granting a marketing authorization for a medicine in Mexico.
The measure is issued under Article 161 Bis of Mexico’s health products regulation and completes the framework created by the July 18, 2025 agreement on reference regulatory authorities.
Entry into force: 30 business days after publication in Mexico’s official gazette
Failure to meet the requirements results in refusal of the application.
Which medicines qualify for the ANVISA equivalence pathway
Article 3 limits the pathway to marketing authorization applications for:
- Medicines containing new molecules
- Generics
- Innovative biotechnological medicines
- Biocomparable biotechnological medicines
- Biological products and vaccines
Article 15 states two conditions apply:
- The product must have essential basic characteristics identical to the one authorized by ANVISA — quality, components and the results of the quality, safety and efficacy studies must match the Brazilian dossier
- The ANVISA authorization must also be in force at the time the Mexican application is submitted
Which ANVISA approvals cannot be used
Article 20 excludes any ANVISA approval that did not follow the ordinary evaluation route:
- Approvals themselves obtained through reliance mechanisms
- Conditional approvals
- Emergency use authorizations
- Approvals granted by court order
- Any other scheme where the ANVISA evaluation is considered insufficient to demonstrate quality, safety and efficacy
The same logic governs ANVISA when it relies on foreign authorities, as set out in its updated list of equivalent foreign regulatory authorities.
Key filing requirements
1. Procedure and format
Applications are filed under homoclave COFEPRIS-04-040 — Solicitud de Registro Sanitario de Medicamentos por Equivalencia de Autoridades Regulatorias de Referencia — using official form FF-COFEPRIS-01, with the dossier presented in CTD format following the applicable ICH guidelines.
2. Evidence of the Brazilian authorization
- Publication of the product authorization in the Diário Oficial da União, together with the electronic verification route on the ANVISA website
- WHO-model Certificate of a Pharmaceutical Product or export registration certificate
- Autorização de Funcionamento de Empresa (AFE) where the manufacturer is located in Brazil
3. Manufacturing and responsibility documents
- GMP certificate for the manufacturer, or the reference number of a certificate issued by COFEPRIS
- Manufacturer representation letter for foreign-manufactured medicines, where the manufacturing site is not a subsidiary or parent company of the applicant
- Risk management plan for biological and biotechnological medicines
- Sworn statement that the medicine carries no alerts or special warnings from ANVISA, other national regulators or the WHO, and has not been withdrawn from any market for safety or efficacy reasons
4. Legalization and verification
Documents issued by ANVISA must be presented in accordance with the provisions of Article 153 of the Regulation. If the aforementioned legal document is issued electronically, it does not require an apostille or legalization and must be submitted in physical or digitized form. COFEPRIS may verify their authenticity, and the applicant must supply the detailed electronic access route and, where applicable, the corresponding credentials. Where authenticity cannot be verified, an apostilled or legalized document is required.
5. Limits of the pathway
Where quality aspects, manufacturing sites or primary packaging sites differ from those approved by ANVISA, or where additional manufacturing sites are needed, the application must follow the ordinary procedure. Secondary packaging sites other than those approved by ANVISA may be requested, provided the corresponding legal documentation is filed.
Review scope and timelines under the ANVISA equivalence pathway
Under the ANVISA equivalence pathway, COFEPRIS reviews only that the documentation listed in Article 25 is complete and properly completed, without further scrutiny of the evaluation already performed by ANVISA. No additional information may be requested, and COFEPRIS may not require documents it issued itself or simple copies.
The resolution deadline is 45 business days. Applications filed before the Acuerdo enters into force are resolved under the rules applicable when they were submitted, and the official form will be published on the COFEPRIS website on the date of entry into force.
Strategic implications for companies entering Mexico
For manufacturers already holding a Brazilian approval obtained through the ordinary route, the ANVISA equivalence pathway makes Mexico a materially shorter second filing — provided the Mexican product is identical to the Brazilian one.
Recognition does not change local obligations. Importers, distributors and marketers remain subject to the Mexican active norms, adverse reactions must be reported to COFEPRIS, and COFEPRIS retains its power to revoke a marketing authorization and to exercise sanitary control at any time.
Companies planning a regional sequence can start from our overview of health regulatory authorities in Latin America.
Official sources
Diario Oficial de la Federación, September 2, 2026 – Acuerdo por el que se emiten los Lineamientos Generales para la aplicación de la vía regulatoria abreviada para el otorgamiento de los registros sanitarios de medicamentos en los que se reconocen como equivalentes los requisitos solicitados, pruebas y procedimientos de evaluación emitidos por la Agencia Nacional de Vigilancia Sanitaria de la República Federativa de Brasil
ANVISA, September 2, 2026 – México reconhece decisões regulatórias da Anvisa e cria procedimento simplificado para registro de medicamentos