Mexico Publishes Long-Awaited Medical Cannabis Regulations

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Mexico’s cannabis landscape is set to be transformed in 2021. The most robust shift will come when lawmakers legalize adult use, which is expected by spring. But the first major change has already arrived this week, with the publication in the country’s Official Gazette of regulations that will establish a framework for medical cannabis in the country.

The regulations are years overdue. As Cannabis Wire previously reported, former President Enrique Peña Nieto issued a decree in 2017 to legalize medical cannabis. But this decree, without regulations, left the country in a legal limbo when it came to medical cannabis access. Then, the Supreme Court ruled in August 2019 in favor of a young patient with epilepsy who could not access medical cannabis products, and ordered the Ministry of Health to issue regulations. That deadline was June 2020, which was extended to September and again to this month.

The Supreme Court has also ordered, as the result of a separate case, the legalization of cannabis for non-medical use, arguing in October 2018 that such a prohibition on personal use is unconstitutional. Lawmakers originally had until October 2019, but, after extensions, as Cannabis Wire has reported, that deadline is now April 2021.

The medical cannabis regulations published on Tuesday are straightforward. They primarily focus on cultivation (both for research and for “the manufacture of pharmacological derivatives and medicines”), public and private research (including clinical trials), and quality control (including good manufacturing practices). 

Those seeking a permit to cultivate cannabis to manufacture medicines will need to indicate, for example, where they will grow, the expected harvest, and security measures. The National Service for Agri-Food Health, Safety and Quality (SENASICA) will oversee the granting of permission to cultivate, and permitted growers will be listed in a national registry. 

Doctors who want to prescribe cannabis medicines will need to register with the Federal Commission for Protection Against Sanitary Risk (COFEPRIS), and medicines will be distributed in pharmacies specifically authorized to do so. The regulations also specifically reference medical cannabis patients—either from Mexico or elsewhere—traveling into the country, and allows them to bring their medical cannabis products with them so long as they have their prescription or authorization.

The regulations also cover import and export. Cannabis products that can be imported include raw materials (seeds and seedlings, for example, but not flower), pharmacological derivatives, and medicines. Only the latter two categories can be exported, but not raw materials.

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