The Decree that regulates the General Health Law on Sanitary Control for the Production, Investigation and Medicinal Use of Cannabis and its Pharmacological Derivatives (the «Regulation») was published on January 12, 2021 in the Official Gazette of the Federation, and will enter into force on January 13, 2021.
The purpose of this Regulation is the regulation, control, promotion and sanitary surveillance of raw materials, pharmacological derivatives and Cannabis medications, for production, research, manufacturing and medical purposes.
The actions regulated by the Regulation are:
1. Supply and manufacture of pharmacological derivatives and medicines;
2. Generation or production of the necessary raw materials for health matters research;
3. Manufacture of medicines and pharmacological derivatives;
4. Regulation of the activities of health professionals who carry out diagnostic, prevention, therapeutic, rehabilitation and palliative care;
5. Quality control laboratories;
6. Obtention of the necessary permits for the planting, sowing, cultivation and harvest of Cannabis and its diverse variety species; and
7. Import and export of raw materials, pharmacological derivatives, and Cannabis medicines or pharmaceuticals.
An important point of the Regulation is the traceability and its system for its administration and implementation, which will be operated by specialized technological tools, implementing a unique, integral, public program of control and supervision that allows a safe control of the packed or finished products.
This Regulation determines the authority that various competent agencies like the Ministry of Agriculture and Rural Development (“SADER”) the SENASICA, the SNICS, the COFEPRIS, the Tax Administration Service (“SAT”) and the Ministry of Economy will have, for the correct development and operation of the medical industry and scientific research of the Cannabis.
It also provides that a person holding a sanitary registry must have a quality control laboratory in accordance with the General Health Law, as it applies to pharmaceutical manufacturing facilities.
On the other hand, the Regulation sets forth that SENASICA must grant planting, sowing, cultivation or harvesting permits and that SADER will be entrusted with the granting of the corresponding import and export permits.
Please note that this Regulation does not regulate any food, beverage, cosmetics, dietary supplements or other industrial products.
For further information in connection with this matter, please contact the partner in charge of your matters or one of the attorneys mentioned as follows:
Mexico City Office
Mr. Alejandro Luna A. (Partner)
Tel.:+52 55 5279.5400
Mr. César Cruz A. (Partner)
Tel.:+52 81 8133.6000
Mr. José Ramón Ayala A. (Partner)
Tel.:+52 442 290.0290