Comprehensive Reform of the General Health Law in Mexico.

January 22, 2026

On January 15, 2026, the DECREE amending, adding, and repealing various provisions of the Health Law was published in the Official Gazette of the Federation (DOF).

The DECREE entered into force the day after its publication, except for the exceptions expressly provided in its transitory articles. Likewise, it expressly repeals all provisions that contradict its content and abrogates the Regulations of the General Health Law on Social Health Protection published in the DOF on April 5, 2004. This DECREE introduces a significant number of structural modifications, which may be summarized in the following main areas:

Planning and investment in infrastructure and equipment:

• The National Master Plan for Health Infrastructure and High-Technology Medical Equipment is created as a mandatory guiding framework for the creation, replacement, or expansion of medical units and for the acquisition of high‑technology equipment.
• Project registration in the Master Plan with a resolution within 2 business days and validity of up to 6 years, renewable.

Digital health and telehealth:

• Digital health is expressly incorporated as a matter of general health, establishing the foundations for the development and regulation of telehealth services and digital health technologies.

COFEPRIS and the Federal Health System:

• The Federal Health System is formalized, and COFEPRIS’ capabilities are strengthened, including temporary authorizations during emergencies, national techno‑vigilance/pharmacovigilance, and sanctions/security measures.

 Consolidated procurement and promotion of local investment:

• The Ministry of Health will coordinate demand and planning for consolidated procurement of health products.
• Incentives are provided for suppliers that demonstrate investment in the production chain of health products, or the start of installation of establishments (factories, laboratories, or warehouses) that form part of that chain, or those that conduct scientific research within national territory.
• The acquisition of innovative health products in consolidated procurement procedures carried out from fiscal year 2026 onward will apply to products programmed for delivery beginning in 2027.

Marketing Authorizations and GMP:

• GMP verification and production process inspection must be carried out directly by the Ministry of Health, and not by authorized third parties, as a requirement for granting marketing authorization.
• Recognition of foreign certificates will only proceed through mutual recognition or equivalency agreements.
• An initial five‑year validity is established for marketing authorizations, with the possibility to request extensions of up to ten years.
• Explicit grounds for cancellation of marketing authorization are defined, including failure to request renewal or unauthorized product modifications.

Pharmacovigilance / Technovigilance:

• Pharmacovigilance obligations are reinforced, and mandatory technovigilance is incorporated upon obtaining marketing authorization for medical devices.
• COFEPRIS will formally coordinate the National Center for Pharmacovigilance and Technovigilance.

Blood, blood products, plasma‑derived products, and stem cells:

• The regulatory framework for altruistic, non-profit donation is strengthened, based on principles of social responsibility, repeat donation, and non-discrimination, and any form of commercial trade or unlawful disposition of blood, blood products, stem cells, and blood derivatives is expressly prohibited. In addition, healthcare establishments are required to implement mandatory hemovigilance systems and to integrate into the national biovigilance system.
• The industrialization of residual plasma for the production of blood derivatives is authorized, while its export is permitted only where national supply is duly ensured, epidemiological and safety requirements are met, and express authorization from the Ministry of Health has been granted.

Electronic cigarettes and vapes:

• A general prohibition is established on manufacturing, importing, marketing, distributing, selling, or advertising electronic cigarettes, vapes, and similar devices.
• Criminal penalties are provided, including 1 to 8 years of imprisonment, in addition to fines.
• Authorizations granted previously are rendered null and void.

Classification of psychotropic substances (Art. 245) and narcotics (Art. 234):

• Lists are updated; psychotropic and narcotic substances are added, reclassified, or restricted (e.g., CATHINE, GHB/GBL, PSEUDOEPHEDRINE, BUPROPION, TRAMADOL, among others).
• A deferred effective date of 180 calendar days is established for the substances CATHINE, DIHYDROERGOCRISTINE, NICERGOLINE, NORPSEUDOEPHEDRINE, PSEUDOEPHEDRINE, ANFEBUTAMONE (BUPROPION), TRAMADOL, GAMMA‑HYDROXYBUTYRIC ACID (GHB), BENZQUINAMIDE, and GAMMA‑BUTYROLACTONE (GBL).

Institutional research committees and CONAMED

• Public, social, and private medical care establishments are required to have Bioethics, Ethics and Research, and Biosafety Committees.
• CONAMED is strengthened by expanding the use of alternative dispute‑resolution mechanisms, including case management, conciliation, mediation, and arbitration.

OLIVARES will therefore continue to monitor the eventual implementation and performance of this DECREE, with the aim of informing and advising our clients in a timely manner.