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Mexico’s General Health Law Regulations for the Production, Investigation, and Medicinal Use of Cannabis and Derivatives

On Jan. 12, 2021, the General Health Law Regulations for the Control of Production, Investigation, and Medicinal Use of Cannabis and its Pharmacological Derivatives (the Regulations) were published in the Federal Official Gazette, coming into force Jan. 13, 2021.

The Regulations regulate, control, promote, and monitor the raw materials, pharmacological derivatives, and medicines derived from cannabis, for production, research, manufacturing, and medical purposes. The Regulations apply to activities carried out for the following purposes: 

I.

 

Primary production,

II.

 

Health research,

III.

 

Pharmacological research,

IV.

 

Manufacturing of pharmacological derivatives and medicines, and

V.

 

Medical diagnosis, prevention, therapeutics, rehabilitation, and palliative care.

Quality Control Laboratories

Each health registration holder must have an independent Quality Control Laboratory1 under the authority of a qualified person with the required academic background and experience, pursuant to the procedures established in the laboratory’s Quality Management System2.

Research

Those interested in carrying out cannabis research must obtain authorization for their Research Protocol from COFEPRIS. 

Production

The cannabis harvesting permit for research and manufacturing must be filed before SENASICA3, in accordance with the provisions of the Regulations, including the authorization of the research protocol or the sanitary registration for the medicine to be produced.

Medical Purposes

Prescription of cannabis medicines must observe the provisions set forth in Article 240 of the General Law of Health4 and its Regulations. Professionals who wish to obtain a bar code for special prescriptions for cannabis medicine will need a permit from COFEPRIS.

Manufacturing

Public and private establishments involved in the manufacturing process, import, export, or use of raw material, pharmacological derivatives5 or cannabis medicines will be required to maintain a specific control book that complies with the requirements established in the Regulations, and to implement security systems in compliance with Article 46 of the Regulation of Inputs for Health and Pharmacopoeia of the United Mexican States6 and satisfy all of the requirements established by the Regulations.

The control book must be authorized by COFEPRIS and must contain a record of the manufacturing of the pharmacological derivatives for which the sanitary registration for sale is being requested. It must also include, as applicable, the following information:

I.

 

Name of the pharmacological derivatives;

II.

 

Lot number;

III.

 

Quantity to be used and balance remaining;

IV.

 

Origin;

V.

 

Use and destination that will be given, and

VI.

 

Process summary.

Producers that consistently require raw materials, pharmacological derivatives, or cannabis medicines must notify COFEPRIS, in January and May, of the quantities that will be needed the following year.

Factories or laboratories that process pharmacological derivatives and storage facilities that hold these products will only be able to sell them to establishments with a valid sanitary license for such purpose.

Owners of pharmacological derivatives must give written notice to COFEPRIS and other relevant authorities of any shortages or waste in their inventories to avoid unintended distribution of such substances.

Destruction

The destruction of pharmacological derivatives must be communicated to COFEPRIS and carried out in the presence of a health authority or verifier.

Import and Export

Raw materials, pharmacological derivatives, and cannabis drugs may be imported into Mexico with customs clearance from the competent authority.

Pharmacological derivatives and cannabis medicines may be exported from Mexico, if they comply with the legal requirements in the destination country.

For the import and export of the above-mentioned products, a previous sanitary permit granted by SADER7 or COFEPRIS must be obtained.

Import and export may not be carried out by ordinary mail under any circumstances.

Importers must keep the import and export permits for a minimum of three years.

Sales and Advertising

Advertising of cannabis medicines must be directed to health professionals only. Promotion and advertising to the general public is not permitted.

Establishments that sell cannabis medicines must fulfill the applicable legal provisions, and must have the following documentation:

I.

 

Sanitary license;

II.

 

Sanitary responsible notice;

III.

 

Control books;

IV.

 

Federal taxpayer registry; and

V.

 

Permission of acquisition in market.


1 Authorized by Federal Commission for the Protection against Sanitary Risks (COFEPRIS) to carry out the analytical tests required for monitoring and control during the different stages of the cannabis process.

2 Mechanism through which the Quality Control Laboratory complies with the provisions of Article 8 of the Health Supplies Regulation and controls quality-related activities.

3 National Service for Agro-Alimentary Public Health, Safety and Quality.

4 Article 240. Only the following professionals may prescribe drugs, if they have a degree registered by the competent educational authorities, fulfill the conditions set forth in the Law, its regulations, and the requirements determined by the Ministry of Health: I. medical surgeons; II. veterinary doctors, when prescribed for animals, and III. dental surgeons, for dental cases. Medical interns will be able to prescribe narcotics with the limitations determined by the Secretary of Health.

5 All cannabinoids and their acidic forms, including the mixture or composition thereof, that have some pharmacological activity, that are identified by their physical, chemical or biological action properties, that are not in pharmaceutical form and that meet the conditions to be used as an active ingredient of a Medicine.

6 Article 46. Public and private establishments that process, import, export, or use narcotics or psychotropic substances for human use shall have control books authorized by the Ministry and a security system for their safekeeping and custody. […]

7 Ministry of Agriculture and Rural Development.

©2021 Greenberg Traurig, LLP. All rights reserved. National Law Review, Volume XI, Number 22
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About this Author

Erick Hernández Gallego, Environmental, Energy and Resources, Attorney, Greenberg Traurig Law Firm
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Erick Hernández represents domestic and international clients on environmental and energy matters, including corporate finance, healthcare, regulatory compliance and real estate matters. Erick has represented clients in several project finance, mergers and acquisitions and electric energy tenders, as well as hydrocarbons tender procedures, both in accordance to the new energy reform in Mexico.

Erick has been practicing Mexican environmental, energy, real estate, administrative and regulatory law for more than 15 years, advising Mexican and...

+52 55.5029.0060
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