DRAFT REGULATION IN MATTERS OF SANITARY CONTROL FOR THE PRODUCTION, INVESTIGATION AND MEDICAL USE OF CANNABIS AND ITS PHARMACOLOGICAL DERIVATIVES IS PRESENTED FOR THE EVALUATION OF THE NATIONAL COMMISSION FOR REGULATORY IMPROVEMENT.

Mexico City, July 31st, 2020.

 

On July 27, 2020, the National Commission for Regulatory Improvement (“CONAMER”) published, in the Regulatory Impact Manifestation System, the draft Regulation in Matters of Sanitary Control for the Production, Investigation and Medical Use of Cannabis and its Pharmacological Derivatives, presented to regulatory impact assessment by the Ministry of Health, through the Federal Commission for Protection against Health Risks (“COFEPRIS”). Herein after “Regulation”.

The following purposes and uses of cannabis are regulated in the draft Regulation:

  • The primary production of cannabis for the supply of the industrial production; for the generation of raw materials for investigation, pharmacological investigation and agronomic investigation; and for the seed production.
  • Investigation with health purposes, pharmacological investigation and agronomic investigation.
  • Industrial activities intended for the manufacturing of molecular complexes, pharmacological derivatives and drugs containing cannabis or its pharmacological derivatives.
  • Activities with medical purposes (diagnostic, preventive, therapeutic, rehabilitative and palliative care).

In this regard, the Regulation foresees dispositions that must be observed by:

  • Quality control laboratories.
  • Establishments for the process of drugs containing cannabis or its pharmacological derivatives
  • Public, social or private establishments conducting investigation activities.
  • Those interested in conducting planting activities.
  • Professionals pretending to prescribe drugs containing cannabis or its pharmacological derivatives, as well as drugstores, pharmacies or apothecaries authorized to publicly supply these drugs.
  • Establishments providing health care services.
  • Establishments providing auxiliary diagnostic and treatment services.
  • Public and private establishments destined to the manufacturing, import, export or use of raw materials, molecular complexes, pharmacological derivatives or drugs containing cannabis or its pharmacological derivatives.
  • Importers and exporters of raw materials (botanical seed, seedling, propagation plant material), molecular complexes, pharmacological derivatives or drugs containing cannabis or its pharmacological derivatives.

The draft Regulation is under the evaluation of CONAMER and hence the dispositions set forth therein are not yet enforceable.

The Regulation’s file will be available, for individuals to submit remarks, for a minimum period of 20 business days.

 

Our practice group in matters of Cannabis remains at your service to clarify any query you may have over this topic.

 

S I N C E R E L Y,

 

Juan José López de Silanes

lopez_de_silanes@basham.com.mx

 

Rodolfo Barreda

rbarreda@basham.com.mx

 

Ricardo Evangelista

revangelista@basham.com.mx

 

Mariana Arrieta

marrieta@basham.com.mx