Cannabis Business Licensing in Mexico

Program Details

Type of Program

• Medical
• THC Threshold: 1%

Regulatory Agencies

• Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
• Federal Commission for Protection against Health Risk
• Secretaría de Agricultura y Desarrollo Rural (SADER)
• Secretariat of Agriculture and Rural Development
• Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (SENASICA)
• National Service for Agrifood Health, Safety and Quality
• Servicio Nacional de Inspección y Certificación de Semillas (SNICS)
• National Seed Inspection and Certification Service
• Servicio de Administración Tributaria (SAT)
• Tax Administration Service 
• Secretaría de Economía (SE)
• Secretariat of Economy 
  

History of Legalization in Mexico

Mexico banned the production, sale, and recreational use of cannabis in 1920 and its exportation in 1927. 

In November 2015, the Supreme Court ruled that four individuals from the Mexican Society for Responsible and Tolerant Personal Use (SMART) would be permitted to grow and consume cannabis personally. The court voted 4-1 that prohibiting people from growing the drug for personal consumption was unconstitutional as it violated the human right to the free development of one's personality. 

In December 2016, a bill to legalize the medical use of cannabis products containing less than one percent THC passed the Senate with a 98-7 vote. In April 2017, the bill passed the Lower House of Congress with a 371-19 vote. President Enrique Peña Nieto signed the medical cannabis bill into law in June 2017. 

On January 12, 2021, the long-awaited medical cannabis regulations were published in country's Official Gazette.

On March 10, 2021, the Senate Chamber of Deputies approved a bill to legalize adult-use of cannabis in Mexico, the bill is now en route to the full Senate for a vote.

Market Metrics

• Population: 128.7 million (2020)
• Market Size: 
• As of 12 January 2021, Mexico is the world's largest national cannabis market by population.
• Projected 2025 Sales: $250 million (Grand View Research)
• Corporate Tax: 30%
• Global Attractiveness Index 2020: 43 (2nd in LAC)
  

Legal Business Types  

The medical cannabis regulations released on 13 January 2021 laid the framework for the production, manufacturing, laboratory testing, import/export, and research of raw cannabis material, pharmacological derivatives, and cannabis medicines. The program is similar to that of European and other Latin American countries, with standards that closely mirror those for the production, manufacturing, and distribution of pharmaceuticals. Patients will access medical cannabis through drugstores and pharmacies with a doctor's prescription. Drugstores and pharmacies must maintain a registry of patients. 

The regulations covered the types of operations listed below. We've provided a high-level summary of some of the requirements. If you are interested in opening a medical cannabis business in Mexico, schedule a complimentary exploratory consultation. We're happy to walk you through it. 

Production

• The National Service for Agrifood Health, Safety, and Quality (SENASICA) will oversee the permitting and registry of Confined Planting Sites. 
• Producers cannot sell directly to the public.
• Application requirements include:
• Submitting a detailed cultivation plan including the amount, variety, and origin of the seed, the sowing density, the planting schedule, the estimated size of the harvest, and more.
• A site layout and map that includes physical barriers and access control to ensure security. 
• A certified copy of the sanitary license.     
• And more. 

Manufacturing

• The Federal Commission for Protection Against Sanitary Risk (COFEPRIS) will oversee the manufacturing of cannabis-based pharmacological derivatives and medications.
• Requirements:
• Your business must comply with the Regulation of Health Products and the Pharmacopeia of the United Mexican States. 
• You must maintain detailed records to track the custody of all raw material, pharmacological derivatives, or cannabis medicines for three years. 
• Suppose you regularly need raw material, pharmacological derivatives, or cannabis medicines. In that case, you are required to notify COFEPRIS each year between January and May with a forecast of quantities for the following year. 
• And more.

Quality Control Laboratories

• COFEPRIS is responsible for the control and monitoring of medical cannabis testing. 
• Your laboratory must have a Quality Management System in place that includes the organization, documentation, and procedures that guarantee that tests are compliant with Good Laboratory Practices and applicable Good Manufacturing Practices.
• You are responsible for ensuring that cannabis supplies and products are not released for sale or use until their quality has been evaluated. 

Import/Export

• Your production business can import cannabis seeds and seedlings with the necessary permits.
• Your manufacturing business can import and export pharmacological derivatives and medicines with the required licenses.
• You cannot, however, import or export cannabis flowers.

Research

• Public and private investigation is permitted.
• You must develop an Investigation Protocol and submit it to COFEPRIS for review and approval.

If you are serious about building a pharmaceutical-caliber medical cannabis company in Mexico, the market potential is massive. Domestically Mexico has the largest addressable population of any country with legal, medical cannabis, and with the possibility to export pharmacological derivatives and medicines globally, the sky is the limit.

Pending Changes to Georgia’s Cannabis Program

Recreational Cannabis Legalization

On 31 October 2018, the Supreme Court ruled that the law prohibiting the recreational use of cannabis in Mexico was unconstitutional. As this was the fifth time that the court had ruled in such a way, it set a binding precedent across the country's court system. The Supreme Court decision gave the parliament until October 2019 to legalize cannabis. As of January 2021, adult-use legislation has yet to pass in Mexico. The original deadline has been extended three times to April 2020, December 2020, and now April 2021. 

A November 2020 poll found that 58% of the Mexican public opposes recreational cannabis legalization.