11 Aug Regulation for sanitary control of Cannabis.
General Context
The Supreme Court of Justice granted Congress a second extension regarding the discussion and approval of secondary regulation of cannabis in Mexico for December 2020. The previous has furthered debate both in the legislative body and commercial and civil associations across the country, following a group of reforms starting that date from 2017.
In accordance to the General Health Law, both the Health Department and the Federal Commission for the Prevention of Sanitary Risks (COFEPRIS, for its acronym in Spanish), are in charge of issuing the applicable secondary regulation.
The draft of the Regulations for Sanitary Control for the Production, Investigation and Medical use of Cannabis (the “Regulations”), has been published by CONAMER in order for the general public to analyze and comment on its content. The proposed terms will very likely be subject to modifications pursuant to this public process and discussions to be held on the legislative process, that is expected to happen during the Congress’s last ordinary sessions period for 2020, to occur during the months of September through December.
Scope and Content of the Regulations
As it names clearly suggests, the content of the Regulations excludes the recreative use of cannabis and addresses its investigation and medical utilization. The general structure of the proposed Regulations contains seven sections, including the creation/regulation of authorized laboratories, the authorized uses/purposes, a special chapter on importation and exportation, qualified seeds and advertising.
If the terms of the draft are approved, interested parties will be obliged to request and obtain new permits and authorizations such as, sowing permits, authorizations for transportation, import/export permits, among others.
The Regulations, pursuant to the inspection and governing attributions of COFEPRIS, create Quality Control Independent Laboratories (Laboratorios de Control de Calidad), which must obtain an authorization by such governmental agency, and are in charge of conducting all necessary tests in the productive process, from importation, to harvesting and final products.
The authorized uses/purposes include investigation, production, and medical and industrial uses. The previous entail the obtention of specific authorizations, such as a special purpose permit for sowing (permiso de siembra), a registry of seeds – plant varieties, and a specific regulation and control measures for medical and industrial establishments.
Importation and exportation of seeds and raw material both require special authorizations and licensing, and a specific certification process in case of importation whereby Mexican authorities determine conformity of the process followed in the country of origin. Raw material and molecular complexes cannot be exported.
Finally, the project limits advertising of products and medication for health professionals, pursuant to the current General Health Law.
Please do not hesitate to contact us in case you have any question.
Contact
Gabriel Espinosa de los Monteros
gespinosa@cuestacampos.com
Carlos R. Padilla
cpadilla@cuestacampos.com