The regulation of health inputs in Mexico is comprised of a broad and complex legal framework. The regulation of cannabis and cannabinoids for medical use is part of this comprehensive system of laws and technical regulations.

As of 2017, the first major step in the regulation of cannabis had been taken following the important amendments to the General Health Law and the Federal Criminal Code. However, it was not until the publication in 2021 of the Regulation of the General Health Law on Health Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives that a formal regulation of cannabis as a pharmaceutical product could be referred to.

The main purpose of the Regulation is the sanitary control, promotion and surveillance of raw materials, pharmacological derivatives and pharmaceutical products of cannabis intended for cultivation, manufacture, research and medicinal use. It allows for the production, pharmacological and medical research, manufacture, importation, exportation and commercialisation of cannabis and its pharmacological derivatives for preventative and therapeutic purposes.

However, regulation and oversight of this type of product is much more sophisticated and complex. In addition to the above Regulation, the processes associated with medical cannabis and its derivatives are subject to the following ordinances.

• The Political Constitution of the United Mexican States is the main legal statute that protects the right of citizens to health.
• The General Health Law is the main legal statute that regulates the sanitary control, surveillance and processes of controlled products, including medicines. It sets forth those main principles and provisions that are applicable to regulation and classification of cannabis products and their derivatives for both medicinal and industrial use.
• The Regulation of the General Health Law on Health Research regulates research for human health, such as:
1. knowledge of biological or psychological processes in humans;
2. knowledge of causes, prevention and control of diseases;
3. production of health inputs; and
4. others.
• The Regulation of the General Health Law on Advertising regulates specific health legal requirements for the advertising of products established under the General Health Law.
• The Regulation of Health Inputs regulates the sanitary control of health inputs, as well as of the establishments, activities and services related to them. It provides the general rules and requirements for securing the relevant approvals for the marketing of drug products and related facilities.
• The Mexican Official Standards are the mandatory technical regulations providing specifications and requirements that must be complied with in processes and by products that may constitute a risk to people, animals, vegetables and the environment. 
• The Mexican Pharmacopoeia is the legal document that regulates the general methods of analysis and the requirements on the identity, purity and quality of drugs and health inputs.
• Self-regulatory industry codes.
• Guidelines issued by the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) or by the Ministry of Health.

Regulatory oversight and enforcement of sanitary laws and regulations in Mexico is mainly carried out by the COFEPRIS (see 1.1 Source of Regulations).

The primary objective of the COFEPRIS is to safeguard public health by ensuring the safety, efficacy and quality of a wide variety of products and industries, including health inputs, medical devices, biologics, cosmetics, food, beverages, and cannabis and its derivatives. It operates under the authority of the Mexican Ministry of Health.

The scope of competence of the COFEPRIS covers the following activities.

• Sanitary authorisation: The agency is responsible for analysing, evaluating and granting authorisations applicable to pharmaceutical products and the facilities associated with them. This includes the granting of marketing authorisations for pharmaceuticals, medical devices, biologics and other health-related products, as well as authorisations for the importation, production, distribution, advertising and sale of these products.
• Surveillance: The agency is responsible for carrying out inspections and activities aimed at ensuring compliance with the legal health framework. This includes monitoring and guaranteeing the efficacy, safety and quality of medicines and therapies, as well as conducting audits of the facilities involved in the production, distribution or sale of these products.
• Pharmacovigilance: The agency oversees the monitoring, collection, analysis and reporting of adverse drug reactions and safety issues related to pharmaceutical products.
• Enforcement: The agency is entitled to impose sanctions, fines or penalties for non-compliance with health regulations. It may take administrative actions, such as suspending or revoking authorisations, permits or registrations, in cases of serious violations or risks to public health. Where the COFEPRIS imposes a fine or measure as a result of a breach of the legal framework, the main remedies typically involve administrative appeals and legal recourses through the judicial system, such as administrative reviews, nullity claims and Amparo lawsuits.

The COFEPRIS plays a key role in ensuring the safety, quality and efficacy of pharmaceutical products in Mexico. In the case of cannabis products for medicinal use, regulation establishes that it must act in collaboration with other agencies and authorities, such as the agricultural and customs authorities in Mexico.

The National Chamber of the Pharmaceutical Industry (known as CANIFARMA) is an industry association and the main self-regulatory body representing the pharmaceutical sector in Mexico.

CANIFARMA plays a crucial role in monitoring the pharmaceutical legal framework in Mexico. It works closely with the COFEPRIS and the industry to ensure up-to-date operation within the legal framework.

Through its Council of Ethics and Transparency of the Pharmaceutical Industry (known as CETIFARMA), it has established a set of self-regulatory instruments (codes of ethics) for its member companies (ie, pharmaceutical companies) to adhere to certain ethical and regulatory standards. These codes are only binding when a member of the industry voluntarily adheres to them.

CETIFARMA is not an authority – its nature is that of a self-regulatory body responsible for the surveillance, monitoring and evaluation of compliance with ethical codes by pharmaceutical company members of CANIFARMA.

The latest versions of the ethical codes were published in and have been valid since 2021.

Sanctions imposed by CETIFARMA on the industry for non-compliance with the codes of ethics are not subject to appeal, and may range from a reprimand to the imposition of fines and temporary or definitive suspension of the rights of the associates.

It should be noted that these sanction procedures are completely independent from those implemented by the sanitary authority as part of its administrative functions. Although it could be the case that they are taken as a reference for the initiation of a formal sanction procedure, this is not a common practice.

The codes establish provisions with an ethical approach (integrity, transparency, etc) and are focused in an important way on the interaction that the industry has with health institutions and patients. This includes patient associations, which in the future will play an important role in the administration and access to pharmaceutical products made from cannabis and its derivatives.

The medical cannabis sector faces a number of challenges, both due to the nature of the product and to the legal and regulatory environment. Some of the main challenges include the following.

• With the legal and regulatory framework concerning obtaining a sanitary registration for the commercialisation of pharmaceutical products and for the offering of medical cannabis products, major obstacles include:
1. lack of clear and sophisticated regulation;
2. lack of understanding of and compliance with the restrictive policies and requirements;
3. lack of knowledge of criteria adopted by regulators;
4. response times; and
5. lack of harmonised regulation at the international level.
• Research and development: The medical cannabis sector lacks extensive scientific research and clinical trials compared to traditional pharmaceuticals. This lack of knowledge hinders the development of standardised dosages, formulations and methods of administration. The paucity of scientific evidence can also lead to skepticism among healthcare professionals and regulators. The costs associated with development of cannabis research, and the lack of funding for conducting it, also represent major obstacles when trying to meet the necessary requirements for obtaining the applicable authorisations.
• Financial services and funding: Due to legal uncertainty and the current prohibition of certain uses of cannabis, many banks and institutions are reluctant to provide services and funding for cannabis-related businesses. This makes it difficult for these businesses to access basic banking services, such as opening accounts, obtaining loans or accepting credit card payments.
• Quality control and product standardisation: Ensuring product quality, safety and efficacy is a challenge in the medical cannabis industry. Variability in cultivation, extraction methods and product formulations can lead to inconsistencies in potency, purity and composition. Establishing standardised testing protocols and quality control measures is crucial, but requires industry-wide co-operation and regulatory oversight.
• Healthcare professional education: Many physicians have limited knowledge about cannabis as a therapeutic option, which can make it difficult for patients to access this alternative treatment.
• Supply chain and distribution: Developing a safe and efficient supply chain for medical cannabis can be complex. This includes growing and processing cannabis plants, manufacturing products and establishing distribution networks, while adhering to strict regulations. Ensuring an adequate supply, especially for patients with specific diseases, is critical.
• Facilities: Relevant challenges include the level of investment required to have establishments meet the necessary supply chain requirements and to have specialised facilities for the production and supply of cannabis for medicinal use, as well as the identification of locations where cannabis businesses can operate. An important aspect to consider for cannabis industries is the fact that not only are products subject to an authorisation, but so are the facilities in which these are manufactured and/or where health services are rendered. In this regard, timeframes and requirements for securing such licences need to be taken into consideration.
• International trade and exportation challenges: In countries where medical cannabis is legal, the exportation and importation of cannabis products can face legal barriers, including restrictions, licensing requirements and limitations imposed by international treaties. These barriers can hinder the growth and expansion of medical cannabis companies seeking to enter global markets.

Also, it is important that the industry does not see these obstacles as a handicap; on the contrary, these factors must be addressed strategically, accompanied by business partners with the sufficient level of technical and legal expertise to be able to implement their projects and take advantage of the emerging global cannabis opportunities.

The current medical cannabis regulatory regime lacks developed and comprehensive regulation. Although, to operate in Mexico, the different actors of the pharmaceutical industry are subject to a wide range of legal and technical regulations and a strict and broad spectrum of obligations and requirements, this regulatory framework is of a general nature and is not focused solely on pharmaceutical products made from cannabis.

Even though the publication of the Regulation of the General Health Law on Health Control for the Production, Research and Medicinal Use of Cannabis and its Pharmacological Derivatives (see 1.1 Source of Regulations) can be considered a great advance in the regulation of medical cannabis in Mexico, there is still a long way to go before affirming that Mexico has the necessary legal framework and the complexity, development and sophistication needed for the operation of this industry.

In this sense, not only is the publication of a legal instrument by the sanitary authority required, but so is a comprehensive legal framework that considers different regulations issued by other authorities for the correct operation of the industry and all its related processes, including importation, sowing, storage, use, handling and sale. This is key in enabling Mexico to be a true actor in the medical cannabis industry at the global level, as well as in the treatment of patients; especially given the constant change and evolution of the industry and of the products themselves, which is where the importance of innovative and dynamic regulation lies.

Lack of Legal Certainty

Considering the history of medical cannabis regulation in Mexico, and the changing criteria of the authorities and political actors regarding this regulation, this should be considered the main risk. The lack of certainty and clarity in regulation is the main challenge currently faced by the industry.

An important factor to consider is the upcoming change in the federal administration over the next few years – an element that will increase the risk of change to the legal framework and its current application criteria.

Lack of Materialisation of Regulation

Another important risk is that, even though there is legal regulation of medical cannabis, its real and practical implementation is still pending. As previously mentioned, having such legal provisions is not enough; it is also necessary to be able to translate these provisions into the real world. To date, the implementation and materialisation of most such regulatory provisions are still pending.

The COFEPRIS, as the main regulator, has yet to define the steps and procedures to be followed for the implementation of each of the activities established by the regulation.

Compliance With the Law

The fact that the pharmaceutical industry is one of the most regulated industries in terms of controls over the raw materials used in its processes cannot be ignored. This is even more relevant when discussing cannabis and its derivatives.

The different players within the industry must be extremely strict with respect to control over the raw materials in the different phases of the life cycle of the drug, as well as with regard to its source and the correct classification of its components, in order to ensure that in the case of cannabinoids (such as cannabidiol – CBD) it does indeed fall within the exceptions established by law for its use.

As expected, the COFEPRIS has the authority to take regulatory and enforcement actions and measures to protect public health, and to ensure compliance with health regulations in Mexico.

Surveillance and enforcement activities, inspections and verification visits can be triggered by:

• an authority’s regular surveillance activities;
• consumer claims and criticism; and
• claims filed by third parties, including competitors.

Inspection visits can take place at (among others):

• points of sale;
• warehousing facilities;
• manufacturing facilities (not applicable to the extent that the products are manufactured abroad); and
• distribution facilities.

In the event of non-compliance with or breaches of the sanitary regulations, the COFEPRIS is entitled to impose measures and sanctions. These penalties will be imposed based on the level of seriousness of the breach and may include:

• warning letters, fines and measures such as temporary or permanent closure of facilities;
• seizure of products; or
• the suspension or revocation of permits and authorisations (including marketing authorisations).

The COFEPRIS may also issue corrective actions or injunctions to address violations.

It should be noted that the above applies regardless of the measures and actions that may be taken by the criminal authorities in the event of perpetration of a crime.

The following include main aspects to be considered in the regulation of tariff and non-tariff barriers that apply to raw materials, pharmacological derivatives and medicines containing cannabis derivatives for their importation and exportation.

For the importation and exportation of raw materials and products, a prior sanitary permit granted by the sanitary and/or agrarian authority in Mexico must be obtained.

Although the classification of products for customs purposes is independent of the requirements applicable under the sanitary regulatory framework, it is important to ensure (to the extent possible) that both classifications are consistent with each other, in order to avoid any contradictory action by either the customs authority or the COFEPRIS.

Depending on the harmonised tariff schedule (HTS) code under which each product needs to be classified for importation purposes, different non-tariff requirements may apply for clearing customs.

In terms of regulation, the importation of raw materials or medical cannabis products and of pharmacological derivatives is not allowed in those cases where such products and substances are prohibited in the country of origin. This significantly limits the sources from which these types of product can be obtained, which has several effects – the main effect being on access to expensive treatments and products.

Another aspect to which the industry must pay special attention is the compliance and qualification of manufacturing facilities and processes (in their different stages) with Mexican regulations and with international regulations. This is to ensure compliance with the regulations on Good Manufacturing Practices for health inputs and access to the applicable certificates for the exportation and sale of pharmaceutical products in the different jurisdictions.

On this particular point, the origin and source of the compounds assumes special relevance, due to the sensitivity that exists worldwide regarding the illegal market of cannabis. Government policies, especially those of the United States, should be aligned on the issue of cannabis.

As previously discussed, the main challenge and legal element affecting the population’s access to medical cannabis is the lack of a comprehensive legal framework with the necessary sophistication for the regulation, control and development of medical cannabis products.

This lack of certainty and clarity in regulation is the main challenge needing to be addressed in order to attract investment to the country, and to benefit the health of the population.

Although there are a number of regulations that can apply to these products, in reality, due to their inherent nature, there are no adequate legal mechanisms in place for industry players to invest and participate in this industry.

Another important challenge is the lack of real understanding and knowledge of the industry and the benefits of the products. This lack of technical knowledge has been one of the main restraints in the development of regulation and openness to these types of products and therapies, including as regards the provision of and access to health services implemented in other Latin American countries (such as Colombia) for the treatment of chronic pain conditions.

Timeframes for the granting of the different authorisations involved are also an important element regarding access to medical cannabis treatments. Authorisations can take up to two years to be issued by the COFEPRIS. In this regard, it is necessary that companies have the sufficient level of expertise required for the processing of these types of authorisations.

Adaptability to change will be a new challenge for actors in the supply chain, not only at the operational level but also at the legal level – they must seek and implement new business and regulatory models that comprehensively ensure innovation, access, safety and compliance.

Following the publication in June 2017 of the amendments to the General Health Law and the Federal Criminal Code, the interest of food and beverage companies in developing products that contain cannabis derivates and its components (including CBD) as ingredients has significantly increased, as has the interest of consumers in acquiring and consuming innovative products.

In general, the use of cannabis derivates with less than 1% tetrahydrocannabinol as a compound in food and beverage is legal, as is the marketing and importation of such products, being (currently) only subject to compliance with the general legal framework and requirements for food products.

Although no specific authorisation is required, it is necessary for companies to take into consideration that food and beverages are subject to strict controls regarding ingredients, safety, labelling and advertising. These controls have increased in recent years as a result of a series of regulatory reforms.

For foreign or imported products, the classification (for customs purposes) of the product under the corresponding HTS code will determine which non-tariff barriers will be applicable (eg, import permits).

Advertising

In some cases, the entity planning or intending to advertise the product must secure an advertising permit; for instance, when the product’s labelling contains elements of a particular front-of-packaging system applicable to food products, aiming to warn about the existence of critical nutriments (eg, fats, sugars, sodium, calories) that exceed certain thresholds and may represent a risk to health.

Advertising must also include legends promoting hygiene and health, except in cases where such messaging is already included in images, scenes, texts or dialogues.

When advertising food products, advertising may not attribute therapeutic, preventative or rehabilitative effects to these products.

Facilities

Facilities in which the storage and distribution of food products is carried out must file a notice of operation with the COFEPRIS within 30 days from the start of operations.

An operational notice is a simple registration and does not constitute an authorisation; therefore, it does not require a formal response from the authority.

Labelling

The labelling of food and cosmetic products is mainly regulated by the Mexican Official Standards, in particular NOM-141-SSA1/SCFI-2012 and NOM-051-SCFI/SSA1-2010, which establish the essential commercial and sanitary information requirements applicable to these products.

On 28 June 2021, the unconstitutionality of the General Health Law’s absolute prohibition regarding recreational and self-consumption activities with cannabis and THC was declared.

Prior to the general declaration of unconstitutionality, any person wishing to participate in recreational and self-consumption activities with cannabis or THC had to file an injunction (Amparo). Following the declaration, the Supreme Court stated that the health authority, through the COFEPRIS, must grant authorisation for such activities to persons of legal age (only for THC and cannabis). However, the COFEPRIS has not yet published guidelines for obtaining such authorisation.

Since guidelines have not yet been published by the COFEPRIS, it is possible to file a writ requesting the relevant authorisation; however, even after the declaration of unconstitutionality, the COFEPRIS has been denying or not responding to such applications, forcing users to file a complaint regarding obtaining authorisation.

As such, in practice the current route involves filing the request and waiting for a denial or lack of response from the authority, and to subsequently approach the court to request compliance with the declaration of unconstitutionality.

In the absence of formal regulation and an express recognition of the legality of the recreational use of cannabis, the declaration of unconstitutionality is the only alternative currently available to users and consumers.

For reference, the courts have declared as unconstitutional the absolute prohibition when it relates to personal consumption.

Having a permit allows one to legally plant, cultivate, harvest, transport, transform, prepare and possess cannabis. This is issued only to adults and for personal use – it does not decriminalise all uses and does not authorise permit holders to sell, buy, market or distribute the cannabis or to give it away, nor does it allow users to create cannabis associations.

Important efforts are being made to address these challenges through advocacy, research and regulatory reforms to improve patient access, product safety and industry development.