The legal framework regulating pharmaceuticals and medical devices is largely federal in Mexico, and includes the following laws and regulations:

the General Health Law (GHL);

• the Health Supplies Secondary Regulations (Reglamento de Insumos para la Salud, or RIS);
• the Health Services Secondary Regulations;
• the Health Advertisement Secondary Regulations;
• the Clinical Research Secondary Regulations (CRSR); and
• several official Mexican standards on specific technical aspects (eg, good manufacturing practices, labelling and stability).

In Mexico, the legal and administrative nature of the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios, or COFEPRIS) is that of an autonomous agency, under the administrative structure of the Ministry of Health (MoH). The GHL created COFEPRIS and gave it administrative, technical and operational autonomy.

Decisions of the regulatory bodies that apply and enforce pharmaceutical and medical device regulations may be challenged through the following optional appeal proceedings:

• an initial administrative review, decided by the same authority that issued the appealed administrative decision;
• an annulment trial, decided by the Federal Administrative Tribunal; and
• an amparo trial, decided by a judicial body, a judge or a court (depending on the nature of the decision being challenged).

The formal requirements for challenging a decision vary depending on the nature of the decision being challenged, but generally the appeal lawsuit will include:

• identification of the affected party;
• identification of the challenged decision;
• identification of the authority that issued the decision;
• a description of the facts; and
• the available evidence.

However, the most important element for successfully litigating regulatory decisions is in-depth understanding of life sciences regulations and public law, so that the science and the law can be properly understood, aligned and argued in each case.

In the last couple of years, there has been a significant increase in litigation relating to decisions taken by health regulators. Litigation has always existed in this area ‒ traditionally in relation to sanctions. There is now a lot of litigation in relation to the system of authorisations and the interpretation of technical regulations. As the regulatory system has evolved into a more complete set of legal rules, and as regulatory work is now being undertaken not only by pharmaceutical chemists but also by lawyers, companies have better understood their rights and have felt increasingly confident in challenging regulatory decisions that affect their interests.

For a whole decade following the creation of COFEPRIS in 2000, regulatory work was highly technical and was mainly handled by pharmaceutical chemists, both in companies and in regulatory agencies. The health law and regulation did not evolve as quickly as the science and the market. The government’s regulatory decisions were frequently taken based not on existing legal rules but exclusively upon technical criteria, which led to a highly discretionary system. Although decisions were always legally vulnerable, the concern of companies was that legally challenging a decision on one product would affect other decisions pending over other products. At the same time, public affairs actions were rather successful in achieving results without the need to litigate.

Two COFEPRIS administrations (2010–18) then brought the legal framework up to date, bringing in lawyers to key positions and modernising the administrative system. This helped to trigger a trend for in-house lawyers and external counsel specialising in the field. At the same time, compliance controls tightened, forcing companies to evaluate, enforce and defend their rights and obligations on the one hand and to put pressure on the area of public affairs on the other.

Finally, the actions of the two most recent COFEPRIS administrations (2018–20 and 2020–23) deliberately isolated the agency from the industry by restricting contact with the regulated industries, replacing experienced examiners and reducing the number of available examiners, leading to a huge backlog that disrupted commercial operations. This created strong incentives for companies to litigate all kinds of pending approval applications.

Taken together, the foregoing has resulted in a significant and sustained increase in litigation, year after year, for the past decade. This led to the creation of the Specialised Chamber for Regulatory Matters within the Federal Administrative Tribunal, which heard 300 cases against COFEPRIS in 2020. Currently, there is significant litigation against a lack of response on new authorisations, renewals, modifications, rejections and inspection procedures, in addition to the litigation of sanction decisions. In 2022, the total number of all types of litigation cases against COFEPRIS skyrocketed to 12,000.

The previous administration (2023–24) partially restarted communication with the regulated industries via the Commissioner for Health Promotion, through technical sessions and goodwill meetings. Both schemes are confidential, non-binding and not regulated by applicable regulations. Nonetheless, these schemes represent an alternative means for the industry to understand COFEPRIS’ interpretation of regulations and requirements. How this new administration (2025–31) will tackle the regulated industries and the severe administrative backlog it has inherited remains to be seen.

The GHL contains many relevant classifications for medicines, including reference and generic/biocomparable drugs, prescribed and non-prescribed drugs, standard and controlled drugs, and so on.

Medical devices are divided into three classes according to the risk they pose to human health, as follows:

• class I – devices that are recognised in medical practice, have proven safety and efficacy, and are generally not introduced into the human body;
• class II – devices that are recognised in medical practice, can vary in the way or volume in which they are manufactured and are regularly introduced into the human body (remaining in situ for less than 30 days); and
• class III – new products, or those recently accepted by medical practice or that are introduced into the human body and remain in situ for more than 30 days.

Clinical trials are regulated by the following key instruments:

• the GHL;
• the CRSR;
• Technical Standard NOM-012-2012-SSA3;
• the Guidelines for Good Clinical Practice published by COFEPRIS; and
• the Decree for the Operation of Ethics Committees, co-ordinated by the National Bioethics Commission.

In general, clinical trials (Phases I–IV) must be:

• preceded and supported by preclinical data;
• conducted in accordance with scientific and ethical principles;
• performed with the informed consent of the participating human subjects;
• executed under a research protocol;
• overseen by a principal investigator; and
• performed in licensed health institutions.

In addition, they must obtain the relevant approvals from a health institution, an ethics committee and COFEPRIS.

Historically, the operation of ethics committees was largely self-regulated and based on international best practice. There was also a lack of co-ordination between COFEPRIS and the National Bioethics Commission (ConBioetica). However, the Decree for the Operation of Ethics Committees (2012) provides a clearer legal framework for ethics committees, establishing their structure and objectives, the role of their members and the requirement to be registered with ConBioetica and COFEPRIS. Unfortunately, ConBioetica has accumulated enormous regulatory delays, forcing serious consideration of litigation of the lack of response.

Notably, the Guidelines for Good Clinical Practice (2012) make clear reference to international best practice, including standards developed by the International Conference on Harmonisation. These good clinical practices will be the basis of a move towards a certification system, for which COFEPRIS has already started to conduct inspections of research sites.

The operation of contract research organisations (CROs) is not fully regulated, with references only found in the guidelines, but there are ongoing initiatives to address this, including the draft PROY-NOM-262-SSA1-2024 on good clinical practices.

Other regulatory measures have been introduced to promote Mexico as a place for conducting clinical research, including the following.

• An important amendment to the RIS – Article 170 of the RIS originally required a certificate of free sale of the country of origin to be submitted as part of an application for obtaining marketing authorisation (MA) for a drug produced abroad, such that it was not possible to have Mexico as the first country of registration. In 2012, however, this rule was changed to make it possible to submit a clinical trial report instead, provided that the Mexican population was included in the trial.
• The creation of third authorised parties for clinical research – COFEPRIS has authorised several public hospitals with extensive experience in clinical research to conduct a pre-evaluation of research protocols. If their report is positive, approval times at COFEPRIS are reduced significantly.

The same rules regulate medical devices and pharmaceuticals.

The procedure for securing authorisation to undertake a clinical trial of a pharmaceutical or a medical device is comprised of three basic steps, which are sequential and cannot be applied for in parallel, as follows:

• favourable opinion of the research protocol by the ethics committee of the health institution where the trial is to be conducted, which – according to the Decree for the Operation of Ethics Committees – must take place within 30 business days of filing;
• authorisation of the research protocol by the director of the health institution where the trial is to be conducted, which must take place under its relevant internal rules; and
• approval of the research protocol from COFEPRIS, which – according to the Federal Law on Administrative Proceedings ‒ must take place within three months of filing.

After their protocols have been authorised by COFEPRIS, most trials are currently recorded in the National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos, or RNEC). The information contained in the RNEC is collected by COFEPRIS in collaboration with those responsible for conducting the clinical trial (ie, a sponsor, CRO or healthcare institution). The RNEC publishes an electronic database that includes only general information about clinical trials. Although limited, this database has seen significant progress; until very recently, almost no local information was made publicly available. Confidential information is not included in the RNEC, and nor is the health information of patients, which will be regarded as sensitive personal information under data protection laws and will be protected accordingly.

On the other hand, there is no binding provision to disclose or publish the results of clinical trials, although the Code of Ethics of the Council of Ethics and Transparency of the Pharmaceutical Industry (CETIFARMA) does contain a specific obligation for sponsors to disseminate the positive and negative results of trials, particularly the adverse events.

There are no specific restrictions regarding online clinical trial platforms. However, it would be important for a platform to comply with the regulations regarding the recruitment of and interaction with patients enrolled in a clinical trial if those functionalities are included in that platform. There could also be other regulatory implications, such as in relation to the advertising of health inputs, services and privacy protection, so it is important that platform content be reviewed on a case-by-case basis.

The data resulting from a clinical trial would be considered personal if the patients enrolled therein are identified. If the results of a clinical trial are presented without providing information or images that could lead to the identification of the patients, such results would not be considered personal data.

It is permissible to transfer the data resulting from a clinical trial to a third party or an affiliate, if the privacy notice states that a transfer will occur and identifies a justifiable purpose for that transfer. When sensitive personal data is involved, the data controller must obtain express written consent for its processing through a signature, an electronic signature or any authentication mechanism established for that purpose.

The creation of databases that contain sensitive personal data must be justified, and must follow legitimate and concrete purposes that correspond to the activities and explicit objectives of the data controller. These kinds of databases are not subject to authorisation before operations commence.

The GHL provides a general definition for pharmaceuticals, and any product that falls under such definition should be considered a pharmaceutical. According to the GHL, a medicine is any substance or mixture of substances of natural or synthetic origin that has any therapeutic, preventative or rehabilitative properties, is presented in any pharmaceutical form and is identified as such for its pharmacological activity and physical, chemical and biological characteristics.

On the other hand, the new definition of medical device contained in Section 3.41 of Standard NOM-241-SSA1-2021 (NOM-241) is broader: “Medical device, instrument, apparatus, utensil, machine, software, implantable product or material, diagnostic agent, material, substance or similar product, to be used, alone or in combination, directly or indirectly in human beings; with any of the following purposes of use:

• diagnosis, prevention, surveillance or monitoring, and/or aid in the treatment of diseases;
• diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or aid in the healing of an injury;
• substitution, modification or support of the anatomy or of a physiological process;
• life support;
• control of conception;
• disinfection of medical devices;
• disinfectant substances;
• provision of information through an in vitro examination of samples taken from the human body, for diagnostic purposes;
• devices incorporating tissues of animal and/or human origin; and/or
• devices used in in vitro fertilisation and assisted reproductive technologies,

as well as those whose main purpose of use is not through pharmacological, immunological or metabolic mechanisms; however, they can be assisted by these means to achieve their function. Medical devices include supplies for health in the following categories: medical equipment, prostheses, orthoses, functional aids, diagnostic agents, supplies for dental use, surgical and healing materials, and hygienic products”.

Initially, any product that falls into this definition should be considered a medical device.

It is also important to remember the list of products that, due to their nature, characteristics and uses are not considered medical devices. Products included on this list are excluded from the medical devices regulation.

There are other categories that are recognised in practice (eg, combination products) but not formally regulated through mandatory instruments.

In general, there is only one type of MA for pharmaceuticals for human health and for medical devices, which is granted by COFEPRIS. The same requirements of quality, safety and efficacy apply, regardless of whether the product is allopathic, homeopathic, herbal or a vitamin pharmaceutical.

However, there is a significant difference between the extent and scope of safety and efficacy data that would be required for an innovator product compared with a subsequent product, and a specific requirement for releasing biologic products after importation. Biotech drugs are also subject to a pre-submission regulatory meeting with the COFEPRIS’ New Molecules Committee.

Please also note that a new class of approvals was introduced during the COVID-19 pandemic (albeit without a legal basis therefor): emergency authorisations. These expired once the health emergency was declared to be over, with regular market authorisations subsequently being required instead.

The period of validity of any MA for pharmaceuticals and medical devices is five years. After this period, MAs may be renewed every five years. In contrast, a recognition letter for orphan drugs (the equivalent of an MA) lasts for two years only.

Also, any authorisation may be revoked by COFEPRIS at any time – for instance, when a new risk to human health is found, if an infringer repeatedly disregards safety measures, or if false information is submitted. MAs may be cancelled if companies fail to submit renewal applications on time.

A recent change to the RIS means that the second and subsequent renewals of MAs ‒ both for medicines and for medical devices – will only be subject to a notification, not to an authorisation.

In general, the procedure for obtaining an MA for pharmaceuticals includes filing the MA application form at COFEPRIS, along with evidence of the following:

• the payment of governmental fees;
• a manufacturing licence or equivalent;
• notice of appointment of a qualified sanitary officer;
• draft labels;
• the information to prescribe;
• certificates of good manufacturing practices for the finished product, its active ingredients and its additives;
• the draft distinctive name;
• the quantitative and qualitative formula;
• quality information; and
• preclinical studies, including pharmacodynamics, pharmacokinetic and toxicology studies.

For products manufactured abroad, it is also necessary to file a representation letter granted to the holder.

The application to obtain an MA for medical devices must be submitted with the following:

• the payment of governmental fees;
• the technical and scientific information that proves the security and efficacy standards;
• draft labels;
• instructions;
• a general description of the manufacturing process;
• a description of the structure, materials, parts and functions;
• certificates of good manufacturing practices for the finished product;
• laboratory tests; and
• bibliographic references, if such are required.

For products manufactured abroad, it is also necessary to file the following:

• a free sale certificate;
• a representation letter issued by the manufacturer of the product;
• a certification of analysis;
• sanitary notification of the distribution warehouse; and
• notification of the sanitary official of the distribution warehouse.

Approval times are as follows:

• for pharmaceuticals that include active and therapeutic indications already registered in Mexico, the decision must be granted within 180 days;
• for pharmaceuticals whose active ingredients are not registered in Mexico but are registered and sold freely in their country of origin, a decision shall be taken within 240 days;
• for new molecules, after a prior technical meeting between applicants and the New Molecules Committee of COFEPRIS, the decision shall be taken within 180 days;
• for homeopathic, herbal and vitamin pharmaceuticals, decisions shall be taken within 45 days; and
• for biotechnological drugs, applications must be resolved within 180 days.

These approval times can be extended if COFEPRIS requires additional information.

For class I medical devices, the decision must be granted within 30 days; for class II, the decision shall be taken within 35 days; and for class III, the decision shall be taken within 60 days.

As with pharmaceuticals, these approval times can be extended if COFEPRIS requires additional information.

There is no mandatory requirement to conduct clinical trials in a paediatric population nor to obtain a waiver from this requirement in relation to individual pharmaceuticals; this is completely optional and subject to stricter requirements.

The modification of MAs can be classified as administrative or technical. Technical modifications are those relating to changes in the formulation, indication or manufacturing process. Administrative modifications include changes to the corporate name or address of the holder, or to the information to prescribe. The assignment of an MA is regarded as an administrative modification. Each application to modify an MA must contain the technical and legal documentation supporting the relevant change.

There are a limited number of cases where an unauthorised product can be imported into the country and supplied to patients, including low-prevalence diseases, donations (eg, in natural disasters), personal use, experimental products for clinical research and medical use.

In addition, if the relevant product is included on the list of products that, due to their nature, characteristics and uses are not considered medical devices, it would not be considered as a medical device and consequently would not require an MA.

The third wave of equivalency decrees introduced the import without registration route. This route was designed to secure the supply of medical products by requiring importers to apply for marketing authorisation within ten days after importing the first batch of the product.

The import of medicines and medical devices that do not have an MA in Mexico is permitted provided they have an MA from certain recognised jurisdictions, that the medicine or medical device is included in the national tender of medical products consolidated by Laboratorios y Reactivos Biologicos Mexicanos, S de R L de CV (BIRMEX) and that an MA application is filed after the first import of the product.

This route allows some companies faster market access, bypassing costly and time-consuming regulatory requirements, but risks patent violations, as the patent linkage system may be overlooked. This could impact third-party patent rights during COFEPRIS’s review of a market authorisation application under the official decree.

Unequal market access and potential patent breaches could violate free trade agreements and enable counterfeit medical products. Likewise, a company can access the market faster through the import without MA route, but if the application is denied, the company risks breaching its public contract and facing economic penalties.

The importation of medicines and medical devices without an MA was previously authorised during the pandemic, in the third wave of equivalency decrees published by the MOH on 28 January 2020 and 22 June 2021. To activate the importation without MA under these decrees, a prior declaration of necessity issued by multiple authorities was required. Both decrees have since been amended and their mechanisms substituted by the current 4 December 2024 decree.

Holders of MAs must comply with good manufacturing practices and stability, pharmacovigilance or technovigilance and labelling standards and regulations; they must also comply with the advertising regulations that apply to pharmaceuticals or medical devices. Product recall obligations have also become relevant of late.

In general, pharmaceuticals and medical devices are subject to post-approval vigilance. These obligations are developed in technical standards, which generally specify the rights and obligations for holders of MAs, distributors, research sites, health institutions, physicians and patients to monitor adverse events or incidents, and to investigate and report them. It is also necessary to have a pharmacovigilance or technovigilance unit, someone responsible for pharmacovigilance and someone responsible for technovigilance, and a pharmacovigilance or technovigilance manual.

However, Phase IV data is only required for more complex products (eg, complex biologics or biotech drugs), as decided by the New Molecules Committee.

COFEPRIS has periodically published lists of applications and lists of granted or rejected MAs. However, these lists are not updated regularly, and frequently contain limited information that excludes confidential information. Full access to individual files is only granted to the applicant.

Although third parties have long been able to file public information requests in relation to any file held by COFEPRIS under the mechanisms overseen by the National Institute for Access to Public Information and Data Protection (Instituto Nacional de Transparencia, Acceso a la Información y Protección de Datos Personales; INAI), COFEPRIS historically resisted providing access to most of the files of MAs, which it regarded as being confidential in their entirety. Nevertheless, through several INAI decisions, an increasing number of data elements can now be accessed. Fortunately, COFEPRIS has now begun to populate a public database on its website that displays key data contained in the MAs for pharmaceuticals.

Confidential information is protected by several special laws, including those related to privacy, IP and administrative procedures, and labour and criminal law.

Mexico’s regulatory framework for medicines and medical devices includes fast-track registration through agreements with 42 global regulatory agencies via the equivalencies registration route.

Mexico signed its first equivalency agreements with Australia, Canada, Switzerland, the European Union and the United States on 10 March 2012. On 29 March 2019, the agreements were expanded to include medicines and vaccines prequalified by the World Health Organization, covering Argentina, Brazil, Canada, Chile, Colombia, Cuba and the United States.

During the COVID-19 pandemic in 2020 and 2021, the equivalencies registration route was expanded to ensure a stable local supply of medical products. This third expansion acknowledged members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) and countries with products prequalified by the World Health Organization.

Thus, the equivalencies registration route established a 60-business day (three-month) fast-track period, as opposed to the traditional registration route applicable to local medical products and subject to a 240-calendar day (eight months) period for COFEPRIS to issue a resolution on MA applications.

The three waves of equivalency decrees are mostly similar, with minor differences. The inclusion of WHO-prequalified medicines and vaccines was logical both scientifically and economically, but the reasoning for extending equivalence to members of PIC/S (the third group) is unclear.

Regulatory reliance refers to the practice of relying on regulatory decisions made by other jurisdictions, which are recognised as trusted regulatory authorities, to approve new medical products.

Regulatory reliance can be applied to the extent determined by the health regulator, either through an abbreviated process for medical products already authorised by another regulatory authority or by directly recognising the regulatory decision.

COFEPRIS aims to use reliance as a method to improve efficiency in supervising medical products. It has adopted the concept of reliance to achieve regulatory alignment with other regional authorities by collaborating with the Pan American Health Organization (PAHO).

This effort resulted in strategies for regulatory certainty for medicines and medical devices, as well as the modernisation of technical regulations such as NOM-241 on good manufacturing practices for medical devices and NOM-177-SSA1-2013 on the interchangeability of medicines. Additionally, several other existing technical regulations are being modified, including NOM-059-SSA1-2015 on good manufacturing practices for medicines.

As mentioned, COFEPRIS can legally expedite market authorisations if a company has approvals from recognised jurisdictions. However, expedited resolutions for such applications are rarely seen in practice.

A pharmaceutical manufacturing plant is subject to a licence, and a medical device manufacturing plant must submit a notice of operation. COFEPRIS is the authority responsible for granting the manufacturing licence and receiving the notice of operation.

To secure a manufacturing licence, a certificate of good manufacturing practices (“GMP certificate”) must be obtained. For that purpose, a COFEPRIS inspection visit to the manufacturing plant must first be requested, to review whether the plant complies with Technical Standard NOM-059-SSA1-2015 on good manufacturing practice for pharmaceuticals. If COFEPRIS determines in the inspection visit that the facility is in compliance, it will grant a certificate, which must be included in the manufacturing licence application. Once the application is submitted, COFEPRIS will take no more than 60 business days to grant the manufacturing licence. The activities typically approved by the manufacturing licence are the manufacture and warehousing of pharmaceuticals in the same facility. The operation licence does not have an expiry date.

The notice of operation for a medical device manufacturing plant only needs to be submitted to COFEPRIS and becomes valid the moment it is filed. The notice of operation requires the appointment of a sanitary officer, who shall be in charge of the facility. The typical activities covered by the notice of operation are the manufacture and warehousing of medical devices in the same facility. The notice of operation does not have an expiry date. With the recent issuance of the new NOM-241 on good manufacturing practice for medical devices, a GMP certificate must be obtained. This new version of NOM-241 has been a source of controversy, as it also applies to manufacturing sites dedicated exclusively to exporting, which are covered by the Manufacturing Industry, Maquiladora, and Export Service (Industria Maquiladora, Manufacturera y de Servicios Exportadores; IMMEX) programme.

As a general rule, establishments involved in the wholesale of pharmaceuticals and/or medical devices are only required to submit a notice of operation to COFEPRIS. The notice of operation enters into effect at the moment of filing and does not have an expiry date.

The exception to the general rule is warehouses dedicated to the wholesale of controlled pharmaceuticals (eg, psychotropic and narcotics) and/or biological products for human use, which are subject to a licence.

Pharmaceuticals are divided into the following six sections in relation to their prescription status:

• section I – prescription pharmaceuticals that can only be acquired by a special prescription or permit issued by the regulatory authority (eg, controlled substances);
• section II – prescription pharmaceuticals that require a prescription to be collected and retained in the pharmacy as well as registration in the pharmacy control books;
• section III – pharmaceuticals that can only be purchased with a prescription that may not be supplied more than three times and that must be recorded in the control book and retained in the pharmacy after the third supply;
• section IV – pharmaceuticals that require a prescription, but which can be supplied as many times as directed by the physician (eg, antibiotics);
• section V – non-prescription pharmaceuticals, authorised for sale only in pharmacies; and
• section VI – pharmaceuticals that do not require a prescription and can be supplied in any establishments other than pharmacies (eg, OTC products).

A vast body of law, including secondary regulations, technical standards and administrative decrees, controls the area of foreign trade and customs law. These are not necessarily co-ordinated with the health regulation, creating frequent issues for companies in the pharma and medical devices sectors.

By way of example, product classifications can differ to the extent that a product may be classified from a customs perspective as a cosmetic for importing purposes and as a medical device from a regulatory perspective for commercialisation purposes. This can in turn have a tax impact on the applicable rate of value added tax.

Depending on the timing and the type of regulation to which the goods are subject, the following authorities could be involved:

• the Tax Administration Service;
• the National Customs Agency of Mexico;
• the MoH, through COFEPRIS;
• the Ministry of Economy, mainly through the General Direction of Standards and the Federal Consumer Protection Agency (Procuraduría Federal del Consumidor; PROFECO); and
• the Attorney General’s Office.

Depending on the type of good, enforcement may also be in the remit of the Ministry of Agriculture, Livestock and Natural Resources, the Ministry of Defence, the Federal Commission of Telecommunications, etc.

Imports must be carried out by an individual or legal entity that is registered in the Importers’ Registry, which is administered by the Tax Administration Service.

Depending on their tariff classifications, certain goods – including certain chemical products, radioactive goods, chemical precursors and essential chemical products – may be subject to registration in specific sectors of the Importers’ Registry. This registration is subject to additional requirements, which depend on the sector in which the importer is to be registered.

Imports of all pharmaceuticals and some medical devices are subject to the obligation of securing specific import permits.

While such imports are normally administered by the MoH through COFEPRIS, depending on the type of product they may also be subject to other types of import or export permits, including those imposed by the Ministry of Economy, the Ministry of Agriculture, Livestock and Natural Resources, the Ministry of Defence and the Federal Commission of Telecommunications.

Among others, the following exceptions to the obligation to secure an import or export permit may apply, but only for non-commercialisation purposes:

• importing for personal use;
• importing for donations;
• importing for experimental use; or
• importing for low-prevalence diseases.

In Mexico, non-tariff regulations and restrictions – such as import permits and licences – are imposed based on the tariff classification (harmonised tariff schedule (HTS) code) and the description of the goods to be imported or exported.

Pursuant to the Mexican Constitution, the executive power may regulate or restrict the importation or exportation of products, provided that Congress grants it such authority. The use of that authority needs to be approved by Congress at the end of each year.

Under the Foreign Trade Law, Congress grants this authority to the executive power, with the condition that – in order for a non-tariff regulation or restriction to be imposed ‒ the corresponding decree or administrative regulation must be published in the Federal Official Gazette, and the goods subject to such regulation or restriction must be listed by tariff classification and description.

When products are subject to sanitary import permits, which in many cases require a marketing authorisation, if the product is subject to inspection upon customs clearance or after importation and the importer cannot demonstrate compliance with these permits (which are non-tariff regulations), a fine ranging between 70% and 100% of the commercial value of the products can be imposed, and title to the goods would pass to the Federal Treasury. If the importer has already disposed of the goods, an additional sanction equivalent to the commercial value of the goods can be imposed.

Mexico has entered into 14 free trade agreements with more than 50 different countries.

Mexico is an active party to the Pacific Alliance (along with Chile, Colombia and Peru). The Pacific Alliance and its framework agreement have specific provisions on regulatory co-operation and product-specific annexes, covering cosmetics, medical devices, dietary supplements and cleaning products. This has started a very promising regulatory harmonisation/convergence process in the region.

Mexico is also party to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (the revised Trans-Pacific Partnership Agreement), which contains promising provisions on the regulatory co-operation side, as well as product-specific annexes.

The United States–Mexico–Canada Agreement (USMCA) entered into force in July 2020 and contains several regulatory annexes for pharmaceuticals, medical devices, chemical substances, cosmetic products and food products.

In Mexico, the private and public markets for medical products have separate rules depending on whether the products are patented. However, this mainly applies to pharmaceuticals and has changed during the new federal administration.

The very general legislative bases of the dual system are contained in two laws: the GHL (Article 31) and the Federal Economic Competition Law (Article 9). However, the rest of the rules are largely contained in separate regulatory instruments of lower hierarchy, including the Addendum to the Agreement for Drug Pricing Co-ordination signed in 2004 between the Ministry of Economy and the National Chamber of the Pharmaceutical Industry, and the technical standard for the labelling of drugs (NOM-072-SSA1-2012).

Private Market

Patented drugs for the private market are subject to a hybrid system that is largely self-regulated and voluntary. Under this system, companies compile their own information about their prices in other jurisdictions and submit that to the authority, which monitors the accuracy of the data.

The manufacturer is required to stamp the price on the label of the product at the end of the manufacturing process. PROFECO verifies that the prices at the point of sale (ie, at pharmacies) do not exceed that price.

Generic drugs, off-patent products and medical devices in general are not part of this pricing regulation, being subject to direct price competition in the market. Newly launched products are initially exempted, as explained here.

Public Market

Until very recently, patented pharmaceuticals for the public market were subject to a different process of annual negotiation. For ten years, such negotiations were held with the Co-ordinating Commission for Negotiating the Price of Medicines and other Health Inputs (Comisión Coordinadora para la Negociación de Precios de Medicamentos y otros Insumos para la Salud; CCPNM), which was created in 2008 and encompassed all major public institutions buying drugs in Mexico, as well as the Ministries of Public Administration, Finance, Economy and Health. However, the last federal administration, which took office on 1 December 2018, introduced two major changes.

First, it eliminated the CCPNM, transferring the whole pricing process to the public procurement system. That change eliminated the prior distinction between pricing and acquisition, which are now defined in the same process for patented medicines.

The estimated price for generic and off-patent products was initially defined by those public institutions co-ordinating the public procurement exercise, based on their market research. However, the price would also be influenced by the discounts offered by the participating bidders and would ultimately be determined in the acquisition award and contract.

The administration then changed the rules again, by means of issuing a new version of the Secondary Regulations for the National Compendium, creating a national formulary from which public health institutions must – in principle – acquire the medical products they need. The new version incorporated new provisions under which a company must provide a maximum price as part of the process to add products; if the addition is approved, that maximum price will become the basis for any public acquisition mechanism.

Newly launched pharmaceuticals for the private market are initially exempted from the maximum retail price (MRP) system ‒ given that, in principle, they would not have a comparator. The manufacturer can set the initial price, subject to a re-evaluation three months after the product launch. The review is conducted to verify whether the product exists in the international market. If this is confirmed, an MRP will be estimated, and the price of newly launched products will be influenced by prices for the same product in other countries but not based on a health technology assessment. The price regulations for medicines do not apply to medical devices.

The Mexican system operates not through a model of reimbursement, but through a model of public procurement of drugs and medical devices.

There is a comprehensive legal regime for public procurement in Mexico, which is overseen by the Ministry of Antibribery and Good Government in co-ordination with the purchasing entity. On 22 December 2023 and 29 October 2024, a presidential decree was published that ordered BIRMEX to consolidate public procurement processes for the public health care sector, which encompasses the Mexican Institute of Social Security (Instituto Mexicano del Seguro Social;IMSS), the Institute for Social Security and Services for State Workers (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado; ISSSTE), IMSS-Bienestar, national health institutes and federal reference hospitals. Under this decree, the Vice Ministry of Health was tasked with preparing a diagnostic of necessities and plan the consolidated purchase of medical products. Thus, BIRMEX now conducts the public procurement process on behalf of the healthcare institutions, under the instructions of the Vice Minister of Health. The first consolidated public procurement process under this scheme began in December 2024 and was still on-going in February 2025, as challenges in its implementation arose.

In general, public procurement operates through three mechanisms:

• public bidding, with a national or international scope;
• invitation to at least three persons; and
• direct awards.

Although public bidding is the general rule, purchasing by invitation or direct award is allowed under certain circumstances, which are listed in the Federal Law for Procurement, Leases and Services of the Public Sector. One of the exemptions refers to cases where there are no substitute products, there is only one possible supplier or the required product is patent-protected.

Accessing the public market for pharmaceuticals does not begin directly with public procurement. Other key regulatory steps must first be met, given that public procurement works through product codes included in the National Compendium for Medical Products. A product can only become part of a public procurement exercise once it has been allocated a code, which ‒ in the case of medicines ‒ is assigned per active ingredient. Note that on 8 November 2022, a national compendium of medical products replaced the basic formulary and several institutional formularies.

Regulations for the national compendium were issued on 22 November 2022, bringing several changes to the system – including one that has been a source of controversy and litigation, relating to the introduction of a new requirement. The new rules now state that an application to add a product must first obtain and submit a sponsoring letter from one of the public payors, representing an access barrier.

Previously, the methodology for determining price was quite clear and included cost-benefit analyses. However, it is no longer clear, and it is also not currently clear whether the new administration will be open to exploring value-based proposals.

The regulatory framework links the rules of prescription and dispensing with those of substitution at the point of sale. There are two scenarios for the private and public markets.

• For the private market, the first rule is that prescribing according to the active ingredient or generic name is mandatory, and that the use of the distinctive name or trade mark of the product is optional for health professionals. The second and perhaps most important rule is that if the prescription contains only the generic name, pharmacists are allowed to substitute the product. Conversely, if the product is prescribed under its distinctive name, then substitution at the point of sale is forbidden.
• For the public market, although the basic rule structure is the same, there is no reference to the option of prescribing by trade mark – meaning that substitution is always allowed. At the same time, it has also been a long-held practice in the public sector to prescribe using the product code allocated in the national compendium, which is based on the active ingredient as well. There are provisions allowing prescriptions to be made under different conditions, but the respective institution would need to authorise such decisions, which is not common.