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In our last post, we alerted you to the publication of the new sanitary control regulations for the manufacture, research and medical use of cannabis and its pharmacological derivatives (the “Medical Regulations”). In this post we provide an overview of what is regulated in medical regulations and what this may mean for your company.
As expected, the medical regulations deal with the control, conveying and sanitary monitoring of raw materials, pharmacological derivatives and drugs. The regulated activities include:
- Primary production for manufacturing supply;
- Extraction of raw materials for research and seed production;
- Health and pharmacological research;
- Manufacture of pharmacological derivatives and medicines and medical activities related to diagnosis, therapy, rehabilitation and palliative care;
- Import, export and marketing.
Activities associated with all of this are authorized by license or permit, and the regulations contain the requirements to obtain them. Activities that are officially approved for the first time include:
- Quality control laboratories
- Waxing for research and industrial purposes
- Cannabis research protocols
- Processing, transport, import (both for industry and for self-consumption)
- Issuing of prescriptions related to cannabis
- Establish facilities where medicinal cannabis products can be sold
The regulations make it clear that COFEPRIS (Federal Commission for Protection against Health Risks) will not be the only authority dealing with this. Although COFEPRIS will continue to be the primary agency for applications related to cannabis, other agencies are also charged with interpreting and applying these medical regulations, as well as issuing permits and licenses. All of this means additional time and expense for companies to include in their business plans for Mexico.
However, there is now a much clearer roadmap for conducting legal cannabis-related activities in Mexico, despite the fact that medical regulations have come into effect without a specific fee schedule for the permits or licenses included (aside from the specific fees set out in the Federal Fees Act ( Ley Federal de Derechos)). With the Temporary Articles of Medical Regulations mandating implementation without affecting the agencies’ current budget for this fiscal year, it seems certain that a fee schedule will be added shortly.
Although the regulations implement federal law (the General Health Act) and are therefore applicable across the country, health-related licenses and permits are tied to the place of residence specified on an application. A distinction is made here: For some activities, such as waxing or processing, the regulations expressly or tacitly provide for a service in different states, as long as you apply for a license for each venue. In other cases, a single permit / license, although associated with a residence, covers the activity regardless of where it is performed (e.g. transportation).
It’s also important to note that licensees can sell to other licensees in the supply chain for medical, research, and refinement purposes. For example, Grow licensees can sell to processor licenses, while processor licensees can sell to distributor licensees. Cannabis can only be sold to the general public through licensed establishments. This means that if you as a patient need to import medical cannabis products for your treatment, you will apply for a special import permit with your prescription. At this point you can order freely (although you order online and have the product sent to you by post) / parcel is prohibited).
Finally, medical regulations provide for the regulation and approval of facilities that provide medical care and sell cannabis products. This includes pharmacies or other specialized medical and therapeutic facilities, but not more general (i.e. convenience) stores. The medical regulations also provide that licenses that approve facilities are renewed after expiry in accordance with other relevant regulations implementing the General Health Act, but do not include an expiration date for licenses from the beginning.
In the coming posts we will take a closer look at the regulated activities, key application requirements and their implications. Stay tuned!