The federal government published in the Official Gazette of the Federation the regulations to allow the production, research, and medicinal use of cannabis in the country.
The federal government published in the Official Gazette of the Federation (DOF) the regulations to allow the production, research, and medicinal use of cannabis in the country, while Congress is expected to debate this year a law to decriminalize the total use of marijuana.
The new regulation, signed by President Andrés Manuel López Obrador, will allow pharmaceutical companies to begin conducting medical research on cannabis products.
The regulation empowers the federal government to monitor the production of cannabis for health, pharmacological and agronomic research purposes, as well as for the industrial manufacture of drugs that may be prescribed, through controlled formats with a barcode, by health professionals authorized by the Federal Commission for Protection against Sanitary Risks ( Cofepris ).
“The drugstores, pharmacies or pharmacies authorized to supply the public with cannabis medications must have a registry of patients, in accordance with the applicable legal provisions on the protection of personal data,” the rule orders.
It is planned to allow the importation into Mexico of raw materials, molecular complexes, pharmacological derivatives, and medicines, as ordered by the Court, whose ruling requires regulating the entire production chain, from the obtaining and storage of seeds to the distribution and commercialization of drugs.
Also, a derivative of cannabis is defined as “all cannabinoids and their acid forms, the mixture or composition of these, that have some pharmacological activity, which is identified by its physical, chemical or biological actions that are not present in pharmaceutical form. and that meets the conditions to be used as an active principle of a medicine ”.
The primary production of the plant will be carried out in “allowed confined sites” isolated from the population, and each holder of a sanitary registry must have a quality control laboratory, also authorized by Cofepris, to monitor the manufacturing process.
In addition to Cofepris, the authorities involved will be the SAT and the Ministry of Economy, in the customs and foreign trade tax part; the National Service of Agrifood Health, Safety and Quality (Senasica), for the application of the Federal Law of Plant Health, and the National Service of Inspection and Qualification of Seeds (SNICS), to regulate the production of seeds.
This regulation is not related to the recreational use of cannabis, authorized by the First Chamber of the Court, in various injunctions granted to individuals as of 2015.
As a result of the jurisprudence generated by these injunctions, the Senate has already approved a Federal Law for the Regulation of Cannabis, pending review in the Chamber of Deputies, which will regulate the production and commercialization for personal consumption.
This reform was published on June 19, 2017 and Congress gave the Executive 180 days to generate the necessary regulations, but it was until July 2020 when the Secretary of Health (Ssa) put a draft regulation for public consultation.
On August 14, 2019, the Second Chamber of the Supreme Court of Justice had granted an Amparo in which it set the Ssa a period of 180 business days to regulate the therapeutic use of cannabis, and on September 27, a federal judge began to require compliance with the sentence.