Mexico: Health regulations for medicines, medical devices, and regulated products

It is no surprise that issues related to human health are subject to extensive rules and regulations aimed at protecting the population. This regulation is based on the Federal Constitution of Mexico, which establishes health as a fundamental right and lays the groundwork for Congress to enact laws related to it.

The main law regulating medicines, pharmaceutical products, medical devices, food, beverages, dietary supplements, cosmetics, etc. is the General Health Law (Health Law), which establishes that these and other products, as well as their processes will be subject to sanitary control.

It is important to note the broad scope of the term " process", which includes all activities related to the manufacturing, packaging, handling, transportation, distribution, storage, supply, etc. of products subject to these sanitary controls.

The Constitution empowers the Executive Branch to issue regulations aimed at clarifying and specifying the laws , without going beyond or against the law issued by Congress, and may cite, among the most relevant, the Regulations of the General Health Law on Health Supplies (Products Regulations), the Regulations of the General Health Law on Health Research (Research Regulations), the Regulations of the General Health Law on Advertising (Advertising Regulations) and the Regulations on Sanitary Control of Products and Services (Products Regulations), among others.

In addition to the Law and its regulations, products and services imported, marketed, or provided in Mexico are subject to the Mexican Official Standards (NOMs), which, from a strictly legal perspective, are administrative guidelines that establish technical specifications, characteristics, processes, facilities, systems, activities, services, and production and operation methods.

On the other hand, there are other provisions issued by the authorities, generally established as internal guidelines, decrees, or agreements, which may or not be published in the Federal Official Gazette (DOF).

Although the Mexican legal system is not based on Common Law, several precedents related to the nature of health-related provisions have been issued by the courts, many of which establish that, since health is a human right, its interpretation as such must be taken into consideration when applying the corresponding provisions.

The specific powers of the various health authorities are defined by the Health Law, which establishes the specific functions of the Executive Branch, the Health Council, and state and local governments.

The products regulated by the General Health Law are, in all cases, regulated at the federal level based on Health Law, its regulations, NOMs and other provisions, including a detailed list of goods and services subject to health control, among which the following stand out:

• research
• food and drinks
• psychotropic and narcotic drugs
• toiletries and cosmetics
• toxic and hazardous substances
• biotechnological products
• chemical precursors and controlled chemicals
• advertising

Most of the definitions of regulated products and services are included in the Health Law and its regulations, and sometimes in other provisions, such as NOMs, the Mexican Pharmacopoeia and other decrees and agreements. Among the most relevant definitions is that of medicines : substances that have therapeutic, preventive or rehabilitation effects in a pharmaceutical presentation identifiable by their pharmacological, physical, chemical and biological characteristics and that can be classified based on preparation methods ( magistral or officinal ), their nature ( allopathic, homeopathic, herbal remedies, marketing (medical prescription, controlled prescription, over-the-counter sale with prescription, over-the-counter sale, etc.) and others (vitamins, biotechnological, orphan, etc.).

Additionally, there are other products that, although not classified as medicines, are subject to similar restrictions, such as toxins, antitoxins, vaccines, serums, parenteral preparations, blood products, biological material, microbial preparations, hormones, enzymes, etc.

In the case of medical devices, there are six main types: medical equipment, prostheses and functional aids, diagnostic agents, dental products, surgical material and hygiene products, which, based on their risk factors and technical knowledge, can be classified into three classes (I, II, III). There are also various NOMs that regulate medical devices and occasionally include additional information or requirements not established by law and/or regulations given their technical or scientific nature.

Another relevant issue for the purposes of Mexican legislation are processes such as nonclinical studies, clinical trials, and similar studies, which are subject to strict regulations. Research involving human beings is subject to prior authorizations and requirements such as being conducted in registered healthcare institutions, under the responsibility of a principal investigator, guaranteeing the potential liability for damages and necessary medical treatment, damages compensation, etc. Various legal entities associated with clinical trials—such as CRT agreements, sponsorships, and CRO activities—are not properly regulated, which has led to the issuance of internal criteria and requirements that are not necessarily duly published or disclosed for potential interested parties.

There are no specific procedures for the use of a product before its marketing authorization is issued, with an exception in the case of clinical trials that may save a patient's life or health, or eliminate pain, provided that written consent is provided.

To market regulated products, these must be registered with COFEPRIS and are granted based on the information available for, including technical and scientific data regarding their stability, efficacy, and therapeutic safety; product use and prescription; labeling; free-sale certificates from the country of manufacture; manufacturing facility GMP’s certificates, etc.

Not all regulated products, such as food, beverages, cosmetics, dietary supplements, etc., are subject to registration or marketing authorization. However, they are subject to verification and health control by the competent authorities.

Health authorities may review and inspect products marketed in Mexico at any time they deem appropriate to ensure compliance with applicable laws, regulations, Mexican Official Standards (NOM), and other administrative provisions.

The Health Law establishes various types of facilities that may be authorized to operate in Mexico, including factories or laboratories for production of medicines, homeopathic remedies, herbal remedies, or biological products for human use. Additionally, some facilities are subject to the submission of operating notices or specific authorizations, as the case may be. These facilities must comply with the specific requirements established in various NOMs (Mexican Official Standards) that describe the operational and manufacturing processes, as well as the applicable characteristics according to the type of products to be manufactured or marketed. These include material handling procedures, product batch and production phase controls, inventory control systems for raw materials and finished products, standard operating procedures for materials and finished products, production controls, manufacturing process validation (analytical laboratory controls), document retention periods, compliance with NOMs applicable to the processes, labeling, compliance with pharmacopoeia requirements, etc.

Another point of particular importance for these types of products and services is their advertising. This has been one of the main areas of verification and punishment by both health and consumer protection authorities, and is particularly aimed at consumer products such as food, beverages, supplements, etc.

“The scope of the term "advertising" is defined in the Advertising Regulations as: an activity that includes all processes of creating, planning, reproducing, and disseminating advertisements in the media for the purpose of promoting the sale or consumption of products or services”.

In this regard, the Health Law establishes the classification of advertising as: intended for health professionals; and the public, this latter may only include advertising related to over-the-counter medicines and herbal remedies and requires a specific permit. Likewise, advertising for other products, such as food, cosmetics, and general consumer products, is regulated by both such regulations and other instruments, such as the Federal Consumer Protection Law, its Regulations, and specific NOMs.

Promotional materials related to pharmaceutical products and medical devices in Mexico are not subject to authorization as long as they do not include information other than the name of the products and/or the entity that manufactures or distributes them. Likewise, activities carried out with healthcare professionals are generally not subject to restrictions. It is possible to organize or sponsor product-related conferences, sessions, courses, etc., and provide product samples, gifts, hospitality, and entertainment.

The distribution and wholesale of pharmaceutical products and medical devices falls under the concept of "processes" subject to health control by Mexican health authorities. As such, these types of activities are subject to certain restrictions and conditions based on the specific type of license, authorization, or health notice issued in connection with them.

The import and export of these goods is considered a "process" subject to sanitary control and subject to various general requirements. Depending on the specific type of product being imported and its applicable tariff classification, specific requirements apply, in addition to the general ones we have discussed in previous articles.

The import of goods is subject to the General Import Tax at the applicable rate according to the tariff classification number. However, pharmaceutical products are generally subject to a 0% rate.

In the case of sales to government healthcare providers, most of these are subject to specific bidding procedures under the Federal Public Administration Procurement, Leasing and Services Law, which establishes the general obligation to acquire goods only through public bidding procedures in which the specific conditions for a sale are indicated.

Similarly, the Mexican Social Security system is based on the direct provision of health-related services by the corresponding government agencies, with no reimbursement procedures for goods purchased directly by the insured population.

Under Mexican law, there are no specific rules regarding financial relationships between pharmaceutical and medical device companies and prescribers and payers, except in some very specific cases involving public health service officials.

In the case of procurement by government agencies, the Federal Law on Public Servants applies, prohibiting the provision of any type of gift to individuals holding public office when this is directly related to their activities as such.

Under Mexican law, there is no specific procedure or system for compensation for potential injuries or damages arising from the use of medications or medical devices. Therefore, individuals who may have been affected or harmed by a medication or medical device may file a lawsuit (ordinary civil procedure) to request compensation for damages.

Under Mexican law, there are no specific provisions or regulations regarding transactional matters for legal entities engaged in the pharmaceutical or medical device business. However, in practice, various practical problems may arise in cases of mergers, acquisitions, spin-offs, and asset sales related to these products, since the transfer of health registrations (marketing authorizations), licenses, and authorizations derived from these transactions can take considerable time to be finalized by the competent authorities.

Likewise, any change in the manufacturing processes and/or background information for which a health registration was issued must be duly reported to the health authorities and, in some cases, may be considered a "change" or modification to the conditions under which a health registration was granted. This can lead to considerable delays in transactions involving these types of products and can represent a challenge for legal entities involved in these types of transactions to avoid the total or partial impossibility of importing, manufacturing, and/or marketing pharmaceutical products and/or medical devices.

The Mexican market represents nearly 130 million potential consumers of products subject to necessary regulation, making it highly attractive for investment in this type of products. It is equally true that this poses significant challenges for carrying out this type of activity in a manner that does not violate applicable legal provisions and allows for smooth operations.