REGULATIONS IN MATTERS OF SANITARY CONTROL FOR THE PRODUCTION, INVESTIGATION AND MEDICINAL USE OF CANNABIS AND ITS PHARMACOLOGICAL DERIVATIVES ARE PUBLISHED.

Mexico City, January 13th, 2021.

 

On January 12th, 2021, the Regulations in Matters of Sanitary Control for the Production, Investigation and Medicinal Use of Cannabis and its Pharmacological Derivatives (herein after “Regulations”) was published in the Federal Official Gazette, same that will become effective as of today, January 13th.

The Regulations govern the following purposes and uses of cannabis:

  • Primary Production[1] of cannabis:

a)For supplying the manufacture of products with medical purposes for the conduction of diagnoses, as well as those with preventive, therapeutic, rehabilitation and palliative care purposes.

b)To generate raw material for conducting health research, pharmacological research, as well as for the manufacture of Pharmacological Derivatives and Cannabis Medications.

c)For seed production.

  • Health research, which includes the development of actions that contribute:

a)To the knowledge of biological and psychological processes in human beings.

b)Knowledge of the links between the causes of disease, medical practice and the social structure.

c)To the prevention and control of health problems.

d)To the knowledge and evaluation of the harmful effects of the environment on health.

e)To the study of the techniques and methods that are recommended or used for the provision of health services.

f)To the production of health supplies.

  • Pharmacological research.
  • The manufacture of Pharmacological Derivatives and Cannabis Medications.
  • Medical purposes for conducting diagnoses, as well as for preventive, therapeutic, rehabilitation and palliative care purposes.

 

It will be understood by:

a)Raw Material, the seeds, seedlings, propagative plant material, stems, leaves or inflorescences of Cannabis, necessary for the preparation of Pharmacological Derivatives or Medicines.

b)Pharmacological Derivatives, all Cannabinoids and their acid forms, the mixture or composition of these, that have some pharmacological activity, and that are identified by their physical, chemical or biological actions not present in pharmaceutical form and that meet conditions to be used as an active principle of a medication.

c)Cannabis Medications, any substance or mixture of substances of natural or synthetic origin that has a therapeutic, preventive or rehabilitative effect, which is presented in pharmaceutical form and is identified as such by its pharmacological activity, physical, chemical and biological characteristics with contents of cannabis sativa, indica or americana or marijuana, its resin, preparations and seeds. It will also be considered as medication, the product that contains nutrients, provided that it is a preparation that contains individually or in association: vitamins, minerals, electrolytes, amino acids or fatty acids, in concentrations higher than those of natural foods and also it is present in a defined pharmaceutical form and the indication for use includes therapeutic, preventive or rehabilitative effects.

 

In accordance with the Regulations, the following authorities shall be competent:

a)The National Service for Agro-Food Safety and Quality (“SENASICA” for its acronym in Spanish), to regulate and promote the health of cannabis, as well as to apply, verify and certify the systems for reducing the risks of physical, chemical and microbiological contamination in Primary Production, in accordance with the provisions of the Federal Plant Health Law and all other applicable legal provisions.

b)The National Seed Inspection and Certification Service (“SNICS” for its acronym in Spanish), to regulate the production of certified seeds, the qualification of seeds and the commercialization and circulation of all cannabis seeds, in accordance with the provisions of the Federal Law of Production, Certification and Trade of Seeds and all other applicable legal provisions.

c)The Federal Commission for the Protection against Sanitary Risks (“COFEPRIS” for its acronym in Spanish), with respect to the regulation, control and health promotion related to the research, manufacturing and medical purposes of cannabis, its pharmacological derivatives and medicines, as well as the control and monitoring of Testing[2] and Traceability[3], in accordance with the provisions of the General Health Law and all other applicable legal provisions.

d)The Tax Administration Service (“SAT” for its acronym in Spanish), to verify compliance with the legal provisions applicable to the import and export of Pharmacological Derivatives and Cannabis Medications and Raw Materials.

e)The Ministry of Economy («SE» for its acronym in Spanish), to intervene, according to its powers, in determining the corresponding tariffs, applicable to the import and export of Pharmacological Derivatives, Cannabis Medications and Raw Material.

 

The Regulation provides provisions that must be observed by:

  • Quality Control Laboratories[4].
  • Establishments, public and private, for the manufacturing process, import, export or use of Raw Material, Pharmacological Derivatives or Cannabis Medications.
  • Establishments, public, social and private, that carry out research activities.
  • Those interested in carrying out cannabis planting activities, in terms of the Regulations.
  • Professionals who intend to prescribe Cannabis Medications.
  • Drug stores, pharmacies or apothecaries authorized to supply the public with Cannabis Medications.
  • Establishments that provide health care services and supply Cannabis Medications.
  • Establishments that provide auxiliary diagnostic and treatment services where Cannabis Medications are prescribed or supplied.
  • Importers and exporters of Raw Material, Molecular Complexes, Pharmacological Derivatives and Cannabis Medications.

 

In accordance with the Fourth Transitory Article of the Regulations, the Ministry of Agriculture and Rural Development, including its decentralized administrative bodies, will have ninety business days, counted from the entry into force of the Regulations [May 21st, 2021], to carry out the normative adjustments necessary for an adequate compliance with the provisions of said Regulations.

 

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


[1] Primary Production consists of the processing of cannabis in the field and it includes the preparation of the field, the crop, the crop’s development, the harvesting and the packaging [art. 3, section XXXI of the Regulations]

[2] Submitting the seed and plant of Cannabis and its pharmacological derivatives, to a verification and testing control, carried out by the competent authorities, which includes a varietal description, safety analysis and any other analysis that is determined.

[3] System that allows to identify the origin and the different stages of the evolution process of products related to Cannabis, for the purposes of production, research, manufacture and distribution; which contains the unified information of all activities for greater control and monitoring capacity by the competent authorities.

[4] The one authorized by COFEPRIS to carry out the analytical tests required for the monitoring and control needed during the different stages of the cannabis process, from its importation and sowing, to obtaining final products.