Today, the Regulations to the General Health Law on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives were published in the Federal Official Gazette. Their purpose is to identify and regulate activities involving cannabis that are deemed permitted because they are intended for medicinal use.
The medicinal use of cannabis comprises: (i) health and pharmacological research, (ii) pharmaceutical production (medicines and pharmacological derivatives), (iii) the diagnosis and prescription of cannabis medicines, and (iv) primary production intended to obtain raw material for such purposes. These Regulations do not address the adult and industrial use of cannabis, which will be regulated separately. In order to meet the various authorized uses, the importation of raw material, pharmacological derivatives and cannabis medicines is permitted, subject to compliance with the established requirements. The primary production of cannabis requires a planting permit at a confined site, for which, among other things, prior authorization of a research protocol or a sanitary registration must have been obtained. It is provided that institutions and laboratories holding a planting permit may contract with an agricultural producer for the performance of the related activities. The prescription of cannabis medicines requires the use of special prescription forms that must include a barcode to be provided by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The Regulations set out the special requirements for the use and safekeeping of the prescription forms. The possession of cannabis medicines must be supported at all times by the medical prescription or the corresponding invoice. The manufacture of pharmacological derivatives and cannabis medicines will be subject to other regulations currently in force that govern the manufacture of pharmacological derivatives and medicines, regardless of whether they contain cannabis or not. In addition, these Regulations state that the preparation of cannabis products will also be subject to the control guidelines that COFEPRIS and other competent authorities jointly determine, which are pending issuance and could constitute a delay in the implementation of this new legal framework. On the other hand, the importation of raw materials (seeds), pharmacological derivatives and medicines will be permitted provided that a Prior Sanitary Import Permit is obtained beforehand. In turn, obtaining such permit entails, depending on the case, the prior obtaining of a phytosanitary certificate, a sanitary registration and/or a sanitary license, which is also subject to compliance with other sanitary provisions currently in force. In order to obtain a prior sanitary import permit for cannabis medicines for personal use, the applicant must attach the medical prescription, which must be presented together with the permit at the customs clearance of the goods. Although these Regulations will enter into force on January 13, 2021, the Ministry of Agriculture and Rural Development will have 90 business days to make the amendments to the current legal framework that are necessary to implement the provisions of the Regulations relating to the primary production of cannabis, including land preparation, planting, crop development, harvesting and packaging. For further information, please contact our experts: Luis Miguel Jiménez, Partner: +52 (55) 5258 1058, lmjimenez@vwys.com.mx Javier Lizardi, Partner: +52 (55) 5258 1021, jlizardi@vwys.com.mx María de Lourdes Salazar y Vera, Associate: +52 (55) 5258 1058, mlsalazar@vwys.com.mx Cinthya González, Associate: +52 (55) 5258 1021, cgonzalez@vwys.com.mx
