The Decree amending, adding, and repealing various provisions of the General Health Law was published in the federal official gazette

Below, we highlight the main aspects of the Amendment that may significantly impact the industry:

1. Digital health (Telemedicine):

The Amendment expressly regulates digital health within the healthcare system, including telemedicine, telehealth, mobile health, electronic medical records, and the use of digital platforms.

For the effective implementation of digital health, public institutions must assess their technological infrastructure, train personnel, integrate and ensure interoperability of their telehealth systems, measure performance, and promote digital inclusion. The Amendment requires that telehealth services be provided by trained personnel through secure systems that guarantee confidentiality and data protection, incorporating specific mechanisms for informed consent and proper documentation of each service provided via digital platforms.

2. Good manufacturing practices for health inputs:

The Amendment establishes that the verification of Good Manufacturing Practices may only be carried out by the Ministry of Health, and not by authorized third parties.

3. Marketing authorizations and technovigilance:

The validity period for renewals of marketing authorizations is extended to ten years. Failure to timely file the renewal application, or any unauthorized modification to the product or to the manufacturer of the raw material, may result in the cancellation of the marketing authorization through an administrative proceeding before COFEPRIS.

The obligation to conduct technovigilance for medical devices is now regulated at the statutory level.

4. Electronic cigarettes and vaping devices:

A total ban is established on the acquisition for commercial purposes, preparation, production, manufacturing, conditioning, packaging, commercial transportation, storage, import, export, marketing, distribution, sale, and supply of electronic cigarettes, vaping devices, and/or any other analogous systems or devices in Mexico. Possession and consumption for non-commercial purposes are exempted.

Devices for heating tobacco are excluded from the Amendment.

5. Narcotic and psychotropic substances:

The lists of narcotic and psychotropic substances have been amended to include new substances.

6. Blood and plasma:

The provisions regulating donation have been amended, adding new definitions, oversight, and traceability for blood, blood products, plasma, and stem cells. The law now provides more detailed regulation on informed consent and the use of residual plasma for the production of blood derivatives, as well as reporting and control systems associated with these processes.

New terms regarding stem cells and regenerative medicine are also recognized.

7. Medical research and institutional committees:

The provisions regulating bioethics, research ethics, and biosafety committees that must operate in hospitals and health centers have been strengthened. This directly impacts the way clinical and research protocols are approved, supervised, and conducted.

8. Consolidated procurement:

The Amendment introduces provisions governing demand planning and consolidated procurement processes for drugs, medical devices, and other health inputs for the public sector. In this context, a policy is established to prioritize suppliers with a productive or research presence in Mexico, which will directly affect the structure and conditions of public supply.

9. Medical infrastructure and equipment:

The National Master Plan for Health Infrastructure and High-Tech Medical Equipment is created for the establishment, replacement, and expansion of medical units, as well as the acquisition of high-tech medical equipment. This is subject to the registration and monitoring of projects in accordance with guidelines issued by the Ministry of Health. The Plan will directly impact the procedures under which infrastructure and equipment projects in the public health sector are authorized and financed.

10. Transitional provisions:

1. The Amendment enters into force on January 16, 2026.
2. The inclusion of new narcotic and psychotropic substances in the controlled lists will enter into force 180 calendar days later, i.e., on July 14, 2026.
3. All previously granted authorizations for electronic cigarettes, vaping devices, and analogous devices are rendered void, and holders must immediately cease all activities related to these products.
4. The Regulations of the General Health Law on Social Health Protection, published on April 5, 2004, are repealed.
5. The Ministry of Health must issue the applicable guidelines for the registration of infrastructure and equipment projects within a maximum period of 90 calendar days, i.e., by April 15, 2026.

At Hogan Lovells, we are ready to advise you on the impacts and opportunities arising from the Amendment to the General Health Law.

Authored by Ernesto Algaba,  Cecilia Stahlhut,  Guillermo Larrea, Juan Carlos Quinzaños, and Paola Neri.