Regulation of the General Law of Health on Sanitary Control for the Production, Investigation and Medicinal Use of Cannabis and its Pharmacological Derivatives

On January 13, 2021, the Regulations of the General Law of Health on Sanitary Control for the Production, Investigation and Medicinal Use of Cannabis and its Pharmacological Derivatives[1] (the “Regulations”) entered into force. The purpose of the Regulations is the regulation, control, promotion and sanitary surveillance of the raw material, pharmacological derivatives and medicines of Cannabis.

This Regulation allows activities of import, cultivation, production, prescription, marketing and export of cannabis, its derivatives and products. However, it is important to point out that the Regulation only contemplates medical and scientific purposes and uses of cannabis. It is important to note that there is still no distinction in regulatory matters between hemp and psychoactive cannabis plants. Only the distinction is made at the content of the cannabinoid level and between CBD and THC.

The Regulation introduces maximum production quotas for raw materials and pharmaceutical manufacturing, as well as the obligation to have quality control laboratories, a quality management system and good practices that guarantee the traceability, safety and quality of production. The above is very similar to the regulatory framework for controlled substances in Mexico.

Regulation of main activities:

1. Production: a permit to plant Cannabis for use in health research and the manufacture of Pharmacological Derivatives and Cannabis Medicines must be obtained from the National Service for Agri-food Health, Safety and Quality (in Spanish Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentario "SENASICA").
2. Investigation: an authorization of the Investigation Protocol must be obtained from the Federal Commission for Protection against Health Risks ("COFEPRIS"). Research on human subjects must comply with the requirements established in the General Health Law, in the Regulations of the General Health Law on Health Research and other regulations applicable to clinical research in Mexico.
3. Production: the public and private establishments dedicated to the process of manufacture, or those which import, export or use Raw Material, Pharmacological Derivatives or Cannabis Medicines, must have Authorized Control Books by the COFEPRIS and a security system for the guard and custody of Raw Materials and the end product.
4. Health professionals: all professionals who prescribe Cannabis Medicines must have a bar code authorized by COFEPRIS. Those establishments that prescribe or supply Cannabis Medicines must have a sanitary license granted by said Commission. At the request of the authority, patients must accredit the legal possession of Cannabis Medicines.
5. Destruction: the destruction of Raw Materials, Pharmacological Derivatives or Cannabis Medicines, must be communicated to COFEPRIS and carried out in the presence of a health verifier.
6. Import: the import may be of Raw Material, Pharmacological Derivatives or Cannabis Medicines, and requires a prior permit granted by the Ministry of Agriculture and Rural Development (in Spanish Secretaría de Agricultura y Desarrollo Rural) or COFEPRIS, depending on the case. The inter-secretarial commission (Ministry of Economy and Ministry of Health) will soon meet to assign tariff classification and customs and regulatory requirements for their legal importation into the country.
7. Export: only contemplates Pharmacological Derivatives and Cannabis Medicines; it requires a previous permission granted by the Ministry of Agriculture and Rural Development or COFEPRIS, depending on the case.
8. Advertising: advertising for cannabis medicines is limited to health professionals (medical brochures and congresses), and advertising to the general public is prohibited. According to this prohibition, the Regulation expressly forbids Cannabis Medicines to be presented in the form of a medical sample or original gift.

As of the entry into force of the Regulation, the authorities will have a period of 90 working days to adapt their regulations.

At the same time, the Congress is discussing a General Law of Cannabis that we hope will extend the purposes and uses allowed for cannabis, to industrial uses, cosmetics, food and beverages and recreational use.

[1] In Spanish “Reglamento de la Ley General de Salud en Materia de Control Sanitario para la Producción, Investigación y Uso Medicinal de la Cannabis y sus Derivados Farmacológicos”