COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios, Secretaría de Salud)
Is Tirzepatide legal in Mexico?
The regulator has approved it as a medicine.
COFEPRIS's 2024 list shows Mounjaro (registration 313M2024, Eli Lilly and Company) in class IV of Article 226, a prescription-only category, valid to 21 November 2029. Lilly México filed in April 2024 under the route for active ingredients already approved in the EU, Switzerland, the US, Canada and Australia. The indication text was not in the sources we could read. On 9 February 2026 COFEPRIS issued an alert about tirzepatide products without registration sold through e-commerce sites and apps in several forms; it said one relabelled cartridge sold as tirzepatide was found by analysis to contain semaglutide and bacterial growth. The alert says tirzepatide must be used under prescription.
Last verified 2026-09-29 · how we verify
Tirzepatide elsewhere
Sources (3)
- 01Registros sanitarios de medicamentos alopáticos expedidos 2024COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2025-01-15 · accessed 2026-09-29
- 02Solicitudes de medicamentos (excepto genérico y biocomparable) ingresadas en 2024COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2025-01-06 · accessed 2026-09-29
- 03Alerta sanitaria: comercialización ilegal de productos con tirzepatida sin registro sanitarioCOFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) · 2026-02-09 · accessed 2026-09-29