On January 12, 2021, Mexico’s Ministry of Health published in the Federation´s Official Gazette the Federal Health Regulations for the Medical Production, Research and Use of Cannabis and its Pharmaceutical Derivatives (the “Medical Cannabis Rules”), which have now taken effect. Therefore, the medical use of cannabis and its pharmaceutical derivatives, as well as the related activities contained herein, are already authorized in Mexico.
Authorized Activities Under Medical Cannabis Rules
The main objectives of the Medical Cannabis Rules are to authorize, regulate, control, promote and oversee the medical and therapeutic use of cannabis’ raw materials, pharmaceutical derivatives and drugs. This includes the related activities of research, production, manufacturing, importation, exportation, sale, and prescription of such cannabis products for medical and therapeutic use in Mexico, as described below:
- Research. Parties interested in undertaking research for medical purposes shall obtain from Mexico’s Federal Commission for the Protection of Health Risks (“COFEPRIS,” as per its acronym in Spanish) an authorization of their research protocols. Such protocols shall comply with requirements under both the Medical Cannabis Rules and the General Health Law´s Regulations on Health Research Purposes.
- Growing/Production. Parties interested in growing and producing cannabis for undertaking research and production of drugs and pharmaceutical derivatives shall obtain a production permit from the Ministry of Agriculture’s National Services of Health, Safety and Agro-food Quality (“SENASICA,” as per its acronym in Spanish). The applicable research protocol or the health registration of the drugs or pharmaceutical derivatives to be produced with cannabis are required for obtaining this production permit. The production permit will allow the seeding, growing and harvesting of cannabis for performing medical research activities, and for manufacturing drugs and pharmaceutical derivatives. Production of cannabis for medical and therapeutic purposes shall be made in confined places duly authorized by competent authorities.
- Prescription. Prescription of cannabis drugs shall be made pursuant to the provisions of the General Health Law (i.e., by duly licensed medical personnel only). Medical personnel shall obtain a bar code for special medical prescription formats in order to prescribe cannabis drugs, and drugstores shall keep a record of the patients consuming them.
- Manufacturing. Cannabis’s raw materials, pharmaceutical derivatives and drugs may be manufactured for sale or research purposes in compliance with good manufacturing standards and after obtaining the required license. COFEPRIS may carry out verification visits to manufacturers when deemed necessary. Cannabis drugs cannot be manufactured in medical samples or courtesy presentations. Cannabis drugs and products for medical and therapeutic use will need health registration with COFEPRIS for their manufacturing and sale in Mexico as may be applicable under Mexican law.
- Sale. Manufacturing facilities or pharmaceuticals manufacturing cannabis raw materials, drugs or pharmaceutical derivatives can only commercialize such products to facilities that have obtained the corresponding health applicable license from COFEPRIS, either as distribution/storage facilities or drugstores, and will also require that the drug or product made of cannabis holds a health registration at COFEPRIS, as applicable.
- Import and Export. Only the following cannabis items and products can be imported for medical or therapeutic use into Mexico: (a) raw materials (b) pharmaceutical derivatives, and (c) drugs. Only the latter two (pharmaceutical derivatives and cannabis drugs) can be exported from Mexico. In order to import or export cannabis drugs and similar products for sale, applicable product registration with COFEPRIS will be also required. Permits will be required for import and export, while postal and parcel delivery services are not permitted for such purposes.
Cannabis Bill for Other Authorized Uses Will Follow
In addition to the Medical Cannabis Rules, a new Federal Law for the Regulation of Cannabis (the “Cannabis Bill”) legalizing and further regulating other types of uses of cannabis (i.e., for recreational, industrial, cosmetic and food purposes) should be approved by the House of Representatives no later than April 15, 2021, after the Nation's Supreme Court of Justice granted the Mexican Congress another extension of the deadline for enacting the Cannabis Bill that has already been approved by the Senate.