In our last post, we alerted you on the publication of the new Regulations on Sanitary Control for the Production, Research and Medical Use of Cannabis and Its Pharmacological Derivatives (the “Medical Regulations”). In this post, we provide an overview of what the Medical Regulations will address and what it potentially means to your business.
As expected, the Medical Regulations deal with the control, promotion and sanitary supervision of raw materials, pharmacological derivatives and medicines. Regulated activities include:
Primary production for manufacturing supply; Raw material generation for research and seed production; Health and pharmacological research; Manufacturing of pharmacological derivatives and medicines and medical activities related to diagnoses, therapeutic, rehabilitation and palliative care; Importation, exportation and marketing.
Activities connected with all of the above will be authorized through licenses or permits, and the Regulations provide the requirements to obtain them. Among the activities that will be authorized officially for the first time are:
Quality control laboratories Growing for research and industrial purposes Cannabis research protocols Processing, transport, import (both for industries and for self-consumption) Export Issuance of cannabis-related prescriptions Set-up of establishments permitted to sell medical cannabis products
The regulations clarify that COFEPRIS (Federal Commission for the Protection against Sanitary Risks)