Mexico moves forward: regulation for medical use

Last January, the Mexican government published the guidelines for the medicinal use of cannabis (Secretaría de Gobernación, 2021).

The text describes the rules for the production of raw materials, pharmacological derivatives and cannabis medicines, and establishes the procedures for product  import and export. With this regulatory advance, the Mexican government launched the medical cannabis industry.

The regulation designates the Ministry of Health and the Ministry of Agriculture to oversee the implementation of the law. Specifically, monitoring duties fell unto the federal commission for protection against sanitary risks (COFEPRIS), the national service for health, food safety and quality (SENASICA) and the national seed certification service (SNICS). The regulations also establish the technical and administrative requirements to guarantee the product quality and traceability.

Cultivation permits are granted by SENASICA and must be accompanied by the corresponding research protocol and/or the application for the sanitary registration for the proposed product. As in other jurisdictions, cultivation activities may be carried out in a confined site dedicated exclusively for this purpose whose characteristics and safety conditions are well defined.

In turn, COFEPRIS will be tasked to grant licences and supervise research activities, manufacture of derivatives and medicines, as well as quality control processes. COFEPRIS is also in charge of overseeing medical uses and prescriptions. Doctors interested in prescribing cannabis medicines should request authorization. The requesting doctor will receive from the state or federal authorities a certain number of codes to prescribe. As in Uruguay, drugstores, pharmacies or apothecaries authorized to supply Cannabis Medicines to the public must keep a registry of patients, capturing data of general interest and following applicable legal provisions on personal data protection.

The guidelines define import and export activities in broad terms. Genetic material (seedlings, cuttings), raw materials, pharmacological derivatives and medicines may be imported. In turn, Mexico may export pharmacological derivatives and cannabis-based medicines. The import or export of dry flower was not included in the regulation.

In summary, Mexico continues to advance in its regulation of medical cannabis, following the public policy axes identified by the government: human rights, health and development. In line with the spirit of the law and following the government’s political project, Mexico seeks to establish a domestic market, generate employment and create a domestic industry. We expect that after the regulation for medicinal use, the regulation will continue to advance and that the Senate and the chamber of Deputies will pronounce on the bill on adult use. Yet, recent comments indicate that the regulation of adult use will be delayed. Regardless, these legislative advances will likely drive major advances for the global cannabis industry.

 

 

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