Three and a half years after the entry into force of the amendments to the General Health Law (hereinafter,   “LGS”) and the Federal Criminal Code (hereinafter,  the “CPF”), and in response to the decisions of the Mexican Supreme Court (the “SCJN“)[1], the Ministry of Health published on January 12, 2021 in the Federal Official Gazette, the Regulation of the General Health Law on Sanitary Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives (hereinafter, the “Regulation“), which entered into force on January 13, 2021 and is aimed to regulate for medical, production, research and manufacturing purposes:

1. Raw material, which consists of cannabis seeds, seedlings, plant material, stems, leaves or inflorescences.

• Pharmacological derivatives, which consist of cannabinoids and their acid forms, their mixtures, or compositions, that have some pharmacological activity, which is identified by their physical, chemical, or biological actions that are not present in pharmaceutical form and that meet conditions to be used as an active pharmaceutical ingredient of a medicine.

• Medicines, which consist of substances or mixtures of substances of natural or synthetic origin that have therapeutic, preventive, or rehabilitative effect, that are presented in pharmaceutical form and that are identified as such by their pharmacological activity or by their physical, chemical, and biological characteristics.

1. Cannabis.

In accordance with article 234 of the LGS, Cannabis should be understood as the cannabis sativa, indica and American plant or marijuana, its resin, preparations, and seeds.[2]

1. Competent Authorities.

The authorities that are competent to monitor compliance with the Regulation are the following: (i) Ministry of Health, through the Federal Commission for the Protection against Health Risks (hereinafter, “COFEPRIS”); (ii) the Ministry of Agriculture and Rural Development, through the National Service for Agri-food Health, Safety and Quality (hereinafter, “SENASICA”) and the National Seed Inspection and Certification Service (hereinafter, “SNICS”); (iii) the Ministry of Economy, and (iv) the Ministry of Finance and Public Credit, through the Tax Administration Service (hereinafter, “SAT”).

1. Main Activities Included in the Regulation.

1. Health and Pharmacological Research

Research is included within the scope of the Regulation, and is understood as studying, under scientific criteria, cannabis, its pharmacological derivatives, and cannabis medicines for use in humans:

1. With respect to which there is no previous experience in the country, have not been registered by the Ministry of Health and, therefore, are not commercially distributed; or
2. That are registered and approved for sale, when it comes to their use with modalities, indications, doses, or routes of administration other than those established, including their use in combinations.[3]

Those interested in carrying out health and pharmacological research activities must: (i) submit to COFEPRIS a request for authorization of their research protocol; and (ii) the researchers must certify, before the applicable research ethics committee, compliance with the provisions of the General Health Law Regulation on Health Research (Reglamento de la Ley General de Salud en Materia de Investigación para la Salud).

Likewise, the Ministry of Health must administer and keep updated, on an annual basis, the national inventory of research carried out on cannabis, which must include the centers where research is carried out, the name of the researchers, scientific publications, and the research monitoring reports.

• Medical prescription

“Medical Prescription” is understood when an authorized health professional indicates the use of medicines and pharmacological derivatives of Cannabis[4]; it is also within the scope of the Regulation.

Health professionals[5] interested in prescribing medicines and pharmacological derivatives of Cannabis under the Regulation, must request COFEPRIS special prescription recipes for cannabis medicines, for which they must submit the following documentation: (i) a certified copy of their professional license, (ii) a copy of their identity document, and (iii) a document specifying the designation of the professionals responsible for prescribing, signed by the director of the institution in the case of hospital institutions.[6]

The prescription of cannabis medicines will be made by health professionals in original and copy. Likewise, drugstores, pharmacies and apothecaries authorized to supply the public with cannabis medicines, must have a registry that contains patient information.

Patients must prove possession of cannabis medications with a copy of the special prescription autographically signed by the authorized professional who issued them, or with the corresponding invoice. [7] In the case of patients who require cannabis medicines for their treatment and are passengers on international trips, they must bring the corresponding medical prescription or, where appropriate, the authorization issued by the competent authority of the country from which they are coming from.[8]

• Production

The Regulation contains two types of production:

1. Primary production, which is defined as the process of cannabis in the field, that includes the preparation of the land, sowing, development of the crop, harvest, and packaging; and
2. Pharmaceutical production, which is defined as the set of operations involved in the processing of cannabis to transform it into medicines or pharmacological derivatives of cannabis.

Those interested in carrying out production activities for health and pharmacological research purposes or for the manufacturing of medicines and pharmacological derivatives, must obtain a cannabis planting authorization from SENASICA. In order to obtain the authorization, they must submit, among other things, the following: (i) the authorization of the research protocol issued by COFEPRIS; (ii) the sanitary license; (iii) the phytosanitary certificate for national mobilization issued by SADER; (iv) the license to transport the harvest of Cannabis seeds and tops issued by COFEPRIS; (v) the quantity, variety and origin of the seed; (vi) the map of the location of the confined site authorized for planting, and the method of destruction of plant residues.[9]

The authorization issued by SENASICA may establish the additional monitoring, control, prevention, and phytosanitary measures to which it will be subject to.[10]

• Manufacturing

Regarding “Manufacturing”, the Regulation regulates those activities aimed at obtaining pharmacological derivatives and cannabis medicines. Those who carry out manufacturing activities are responsible for the safekeeping and custody of the raw material, pharmacological derivatives, and cannabis medicines that they possess, for which they have the obligation to keep, for a period of three years, the documents evidencing their acquisition in accordance with the provisions of the Health Supplies Regulations (hereinafter, “RIS”) and the Pharmacopoeia of the United Mexican States (hereinafter, the “Pharmacopoeia”).[11]

Likewise, public or private establishments focused on the manufacturing process, importation, exportation and use of raw materials, pharmacological derivatives and cannabis medicines, must have control books authorized by COFEPRIS and a security system for its safekeeping and custody.[12]

Similarly, those who carry out manufacturing activities must, among others, comply with the following: (i) use cannabis in a diluted and dynamic way when it is used in homeopathic medicines; (ii) not provide cannabis medications in the form of a gift or a medical sample; (iii) notify COFEPRIS about the disappearance of raw materials, pharmacological derivatives and medicines of cannabis; (iv) during the months of January to May, inform COFEPRIS of a forecast of the amounts that they will demand during the following year; (v) be subject to the provisions of the RIS in the case of the manufacturing of pharmacological derivatives and medicines of cannabis; (vi) cannabis may only be used in homeopathic medicines when it is diluted or dynamized; and (vii) a herbal remedy may not include cannabis of natural or synthetic origin.[13]

Those who own raw materials, pharmacological derivatives and cannabis medicines, may only market them to establishments that have a sanitary license (Licencia Sanitaria) to act as storage facilities and as distributors of medicines and biological or blood products for human use, drug stores, pharmacies or apothecaries authorized to supply them to the public. [14]

• Destruction

The destruction of raw materials, pharmacological derivatives and medicines of cannabis must be reported to COFEPRIS, must be carried out in the presence of a sanitary verifier and must be carried out in accordance with the provisions of, among others, the RIS.

• Laboratories of quality control

The Regulation states that the holders of health authorizations must have an independent quality control laboratory authorized by COFEPRIS to carry out the analytical tests required for the monitoring and control of the different stages of the cannabis process, from their importation and sowing, until obtaining final products. The laboratory must be under the authority of a person who, in accordance with the procedures established in its quality management system, is academically and empirically qualified.[15]

Among other requirements, the quality control laboratory must have a sanitary license (Licencia Sanitaria); a sanitary responsible manager; standards and samples control books; qualified personnel, areas and equipment in accordance with the guidelines of its health management system; cleaning, maintenance and operation procedures; validated analytical methods; sampling and recording procedures; test results records; an analytical transfer protocol, and a control of the animals acquired for testing.

• Importing and exporting

For import purposes, raw materials, pharmacological derivatives and medicines of cannabis can be imported into Mexico; for export purposes, only pharmacological derivatives and medicines of cannabis can be exported from Mexico. The import and export of the aforementioned products, as the case may be, will be subject to prior health authorization issued by SADER or COFEPRIS and may not be carried out by postal mail.[16]

In the case of importation of raw material, the authorization will be issued by the Ministry of Health with a prior favorable opinion from SENASICA, which will contain the necessary phytosanitary requirements to reduce or mitigate the risk of introduction of pests to the country and ensure the adequate level of phytosanitary protection of the country.[17]

To import pharmacological derivatives and cannabis medicines, it is necessary to request a prior import authorization from COFEPRIS, for which the applicant must submit: (i) health license, (ii) health liability notice, (iii) control books and its annual forecasts, (iv) a copy of the authorized research protocol (when the import is for research purposes), and (v) a copy of the current health authorization (when the import is for medicine manufacturing purposes). To import pharmacological derivatives or medicines of cannabis, the importer must inform COFEPRIS, three business days in advance, the date and customs office through which the merchandise will be imported and, after customs clearance, submit the documentation related to the customs clearance of importation of the merchandise.[18]

• Advertising and marketing

It is important to mention that the Regulation only provides for the advertising of cannabis medicines, which only may be authorized if aimed at health professionals; consequently, under no circumstances they may be advertised to the general public.[19] In this regard, it will not be possible to advertise raw materials or pharmacological derivatives of cannabis.

Regarding the commercialization of cannabis medicines, establishments must have, among others, the following: (i) health license, (ii) a sanitary responsible, (iii) the control books, (iv) the federal taxpayer registry and (v) the acquisition authorization in place.[20]

If you require more information regarding the contents of this note, please contact the following persons:

Guillermo Solórzano Leiro, guillermo.solorzano@s-l.mx

Direct Phone: +52 55 50620057

Luis López Linaldi, luis.linaldi@s-l.mx

Direct Phone: +52 55 50015409

Alan Osorio Aragón, alan.osorio@s-l.mx

Direct Phone: +52 55 50620074

[1] Contained in the judgment of the Amparo trial 57/2019, issued on August 14, 2019.

[2] Article 3, Section VII of the Regulation.

[3] Article 3, Section XXII of the Regulation.

[4] Article 3, Section XXVIII of the Regulation.

[5] In accordance with the provisions of Article 240 of the General Health Law, health professionals who are empowered to prescribe narcotic drugs are the following: (i) surgeons, (ii) veterinarians, when they are prescribed for the application in animals, and (iii) dental surgeons, for dental cases.

[6] Article 27 of the Regulation.

[7] Article 31 of the Regulation.

[8] Article 32 of the Regulation.

[9] Articles 19, 20 and 21 of the Regulation.

[10] Article 22 of the Regulation.

[11] Article 34 of the Regulation.

[12] Article 35 of the Regulation. The safekeeping and custody system must comply with the requirements of article 46 of the RIS and the Pharmacopoeia.

[13] Articles 35, 37, 38, 39, 40, 41, 42 and 43 of the Regulation.

[14] Article 40 of the Regulation.

[15] Article 3, Section XXIII, and article 8 of the Regulation.

[16] Articles 47, 48, 49 and 51 of the Regulation.

[17] Article 55 of the Regulation. SENASICA will issue its opinion in relation to the importation of raw material in the case of botanical seeds for planting, seedlings for sowing and plant propagation material.

[18] Article 60 and 63 of the Regulation.

[19] Article 77 of the Regulation.

[20] Article 79 of the Regulation.