The regulatory regime
In all cases, pharmaceuticals, devices and other products and services that have effects on human health are regulated at the federal level. These include, among others: research; food and beverages; human tissue and DNA; psychotropic and narcotics; toiletries and cosmetics; toxic substances; publicity; tobacco, vaping and alcoholic beverages; medical software and telemedicine; etc.
The Health Law and other provisions establish general licence, procedure and penalty requirements applicable to these goods and activities. Regulations, NOMs and guidelines establish additional or more specific requirements to each type of product and service. The implementation and application of these provisions may be carried out by the local state authorities.i Classification
The Health Law, its regulations and other provisions provide specific definitions of medicines, medical devices and other products and services subject to sanitary control. In some cases, where specific legal provisions have not been enacted, it is quite common to have the competent authorities resort to provisions based on 'similarities' or broad general concepts within other provisions. These determinations based on similarities have greatly increased during the covid-19 pandemic, and products that were not considered as regulated or that, because of their dual or variable use, were not in practice regulated by the health authorities have been under scrutiny of the authorities for the past several months.Medicines
The Health Law defines medicines as substances having therapeutic, preventive or rehabilitative effects identifiable on pharmacological, physical, chemical and biologic characteristics and classified based on diverse criteria as: allopathic; homeopathic; herbal remedies; prescription; controlled prescription; over the counter; vitamins; biotechnological; orphan drugs; traditional medicines; etc.
In addition, other regulated products include toxins, anti-toxins, vaccines, serums, parenteral preparations, blood products, microbial and fungal preparations, hormones, enzymes, etc.Medical devices
The Health Law identifies six main types of medical devices (medical equipment; prostheses and functional aids; diagnostic agents; dental products; surgical material; and hygienic products), which are classified based on their risks, safety and efficiency into three classes: Class I, well-known in medical practice and not body-invasive; Class II, known in medical practice or body-invasive for periods shorter than 30 days; and Class III, new or recently accepted in medical practice or remaining in the body for periods greater than 30 days.
Certain NOMs and internal criteria include additional requirements for products that, although not formally medical devices under the Health Law or its Regulations, have been included under its scope by the authorities, as possible new technologies (apps and software), electric and electronic products used in 'wellness', holistic therapies and similar procedures, telemedicine services, etc.ii Non-clinical studies
There is no specific restriction regarding the use of non-clinical studies. The party performing the non-clinical study is solely responsible for assuring good laboratory practices and that these studies do not represent a risk to human health. Under certain state legal provisions, certain risks exist of interpretations that may lead to restrictions for these activities.iii Clinical trials
In contrast with non-clinical trials, clinical trials are subject to extensive regulation. The Health Law, the Research Regulations and specific NOMs regulate clinical trials. These may involve research on prophylactic, diagnostic, therapeutic and rehabilitative resources; bio safety risks; DNA and biotechnology; and radiation.
Clinical trials are classified based on the risk they may pose to the test subjects and are divided into non-risk research; minimum-risk research; and greater-than-minimum-risk research.
Research involving human beings requires authorisation prior to its commencement. The performing parties must provide the authorities with information regarding the scope and purpose of the research, the main investigator, approval of the institution's committees and informed consent of the subjects.
In principle, clinical research should only be carried out at health institutions under the direction of a principal investigator who is a health professional, member of such institution and the latter guarantees possible damages arising therefrom, medical treatment required and potential indemnification to subjects.
In the case of sponsorship or other forms of remuneration, measures to prevent conflicts of interest for protecting test subjects, preservation of results and assignment of resources should be implemented.
Certain legal concepts associated with clinical trials, such as clinical research trial agreements and sponsorship and activities, are not regulated by Mexican law; however, in practice the authorities have issued internal criteria, compliance with which is required to obtain the authorisations, and included some references in NOMs or other administrative criteria.
Currently, it has become a fairly common activity for legal entities or individuals to carry out data and information collection of a medical or investigative nature thorough new technologies (apps, software and similar means) that are not specifically regulated as information considered as a clinical trial subject to permits and authorisations.iv Named-patient and compassionate use procedures
Only one exception exits for using a product before it has received marketing authorisation (MA). This is in the case of clinical trials that may save a patient's life or health, or eliminate pain, provided the patient has supplied written consent.
Notwithstanding, the Mexican courts have issued recent criteria establishing that irrespective of the restriction to import and use regulated products subject to MA, the health authorities must permit their use considering the greater relevance of the human right for life in relation to the general health protection and exclusivity of cleared products.v Pre-market clearance
Currently, only medicines and medical devices require registration with COFEPRIS, the same that is granted based on available information regarding their safety, among which is: technical and scientific data; therapeutic efficacy and safety; use and prescription; labelling; certificates from country of manufacturing; etc.
If the product is considered safe, the registration is issued and the products can be manufactured, imported and marketed in Mexico. As an alternative to the general registration process, this information can be pre-reviewed by a private authorised entity, and a fast-track registration may be granted. This kind of registration is also available for products holding MA in jurisdictions with which mutual recognition agreements have been executed.
Both Mexican and foreign laboratories that manufacture pharmaceutical products may obtain MA. For medical devices, it is not necessary to have manufacturing premises in Mexico or abroad to obtain MA; however, the requesting party must be registered with COFEPRIS and provide the required documents.
In November 2020, the Executive Branch ordered the Ministry of Health and COFEPRIS to issue the corresponding marketing authorisations for diverse regulated products within a five-day period following the filing of the corresponding dossier. This order and express issuance of the corresponding MA will depend on the existence of an MA issued by other countries with mutual recognition agreements and that the complete dossier is duly filed.vi Regulatory incentivesPatent term extensions
Mexico does not provide patent term extensions or grant delays. However, as a signatory of the Unites States–Mexico–Canada Agreement (USMCA), ratified and mandatory as of 1 July 2020, it shall enhance intellectual property protection for pharmaceutical products, because, under such agreement, the member parties must 'make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process'.Link between regulatory approval processes and patent expiry
The Regulations for the Industrial Property Law and the Goods Regulations establish a linkage mechanism to observe patent rights. This has been subject to a considerable number of litigation actions since its enactment.
The Mexican Patent Office (IMPI) issues a Gazette containing patents in force covering:
- active ingredients;
- biologics; and
- some use patents.
Published patents do not have a correlation with approved products (patents can be published even if the corresponding product is still at a clinical trial stage, or the approval has been refused).
Upon receiving an MA application for a generic drug or biosomilar, COFEPRIS must request from IMPI an opinion regarding whether the requested MA infringes patent rights. The applicant is informed of the IMPI's opinion, without the involvement of the patent holder.Data and marketing exclusivity
Data and marketing exclusivity for pharmaceutical products is an obligation under USMCA, which has only been regulated through an internal guideline from COFEPRIS, that includes a five-year period of data exclusivity.vii Post-approval controls
Holders of MAs must maintain the conditions upon which such were granted while these are in force. Changes thereto may result in cancellation. Changes to the background upon which an MA was issued must be filed for approval. The health authorities may verify that premises where processes are carried out meet the necessary GMPs or sanitary conditions.
In the specific case of pharmaceutical vigilance, in addition to the general procedures set out by the Health Law, those of the applicable NOM must also be satisfied.viii Manufacturing controls
Medicines, devices, food and beverages, tobacco and other regulated products' manufacturing is subject to sanitary control and includes requirements regarding premises where related 'processes' are carried out. In some cases, laboratories or other kinds of premises may be authorised to process products subject to this requirement through the issuance of a sanitary licence. The Health Law establishes different types of premises that may be authorised to operate in Mexico, including factories or laboratories of medicines, homeopathic or herbal remedies or biological products for human use, etc.
Premises where pharmaceutical products are manufactured must as a general rule evidence 'good sanitary practices'; have quality control laboratories; appoint specific individuals with the health authorities as representatives of the entity; provide, as required, information regarding products, services, processes and, as the case may be, specific administrative controls (e.g., narcotics and psychotropic).
Compliance with these requirements can be verified through inspections following the filing of an application or through an alternative verification process called an operation requirements compliance certification. Once approved, the Health Authority will issue the corresponding licence.
Additionally, these premises must meet specific operational and manufacturing requirements set out in certain NOMs depending on the kind of products to be manufactured, including, inter alia, materials handling procedures; lot controls and production; testing; raw materials and finished-product inventory control systems; standard operating procedures for production controls; manufacturing processes' validation; compliance with NOMs certifications; samples and documents preservation; labelling compliance; etc.ix Advertising and promotion
The Publicity Regulations define the term 'publicity' as any activity that includes all creation, planning, playing and broadcasting processes of advertisements in communication media with the purpose of promoting the sale or consumption of products or services.
The Health Law differentiates between publicity intended for health professionals and for the public, the former being that regarding the characteristics and use of medicines, medical devices and medical or scientific information used for publicity or promotional purposes restricted to specialised media and based on the content of the products' MA and the latter intended for the public at large, which requires specific permits and is only applicable to over-the-counter medicines and herbal remedies.
Promotional materials regarding pharmaceutical products and medical devices in Mexico are not subject to authorisation, provided these do not include information other than the names of the products and the entity manufacturing or distributing them, or both. Likewise, activities carried out involving health professionals are generally not subject to restriction, because it is possible to organise or sponsor congresses, sessions, courses, etc. regarding products, and to provide sample products, gifts, hospitality and entertainment.x Distributors and wholesalers
Distribution and wholesale of pharmaceutical products and devices are 'processes' subject to sanitary control by the Mexican health authorities and subject to restrictions and conditions depending on the specific type of sanitary licence.
The Health Law and applicable regulations establish different premises subject to sanitary control and specific requirements for each. Generally, premises for the wholesale and distribution of pharmaceutical products and medical devices are subject to compliance with specific requirements for warehousing, transportation and control.
Several additional requirements and restrictions for the distribution and wholesale of pharmaceutical and devices bound for the public sector have been enacted during the current administration, many of which have been established through administrative guidelines or internal criteria rather than through formal laws or regulations.xi Classification of products
The Health Law and corresponding regulations set the rules and conditions for classifying pharmaceutical products, medical devices and other regulated products and services. This classification determines the conditions for marketing goods and specific permits and authorisations for related processes. The specific criterion for products classification may be determined by the health authorities.xii Imports and exports
The Health Law identifies importation and exportation of goods as a 'process' subject to sanitary control and general requirements. Specific requirements apply based on the product and its tariff classification.
For products imported into Mexico, the general requirements include registration of the importer of record with the General Importer's Registry, the appointment of a customs broker or in-house broker, and registration with the Specific Sectors Importer's Registry for clearance through specific customs houses.
Goods importation triggers general import duties at the rate for tariff classification number and value of goods. Most products exportation is exempt from export duties. Likewise, importation of goods triggers value added tax. For finished pharmaceutical products, this is zero per cent or exempted. Medical devices are subject to the 16 per cent general rate under the Value Added Tax Law.
Non-tariff requirements are also applicable. For medicines and pharmaceuticals, these are generally subject to the issuance of an import or export permit by COFEPRIS. Medical devices are generally only subject to presentation to the customs authorities of the corresponding MA.
Other products subject to controls may include those bound for wellness purposes, certain kinds of food and beverage and other apparently unrelated items that may represent a health risk.xiii Controlled substances
Controlled substances include all psychotropic and narcotic substances. The list of such goods is included in specific chapters of the Health Law, which establishes the general requirements applicable to these goods and their classification based on their use and effects.
Under the Health Law, psychotropic substances are divided into those:
- with minimum therapeutic value by virtue of their possible unlawful use and that constitute a particularly serious public health problem;
- with therapeutic value but that constitute a serious public health problem;
- with therapeutic value but that constitute a public health problem;
- with considerable therapeutic value that constitute a minor public health problem; and
- with no therapeutic value and that are generally used for industrial purposes.
Processes involving these substances and those considered as raw materials for manufacturing illegal drugs are subject to specific controls, set forth in the Federal Law for the Control of Chemical Raw Materials, Essential Chemical Products and Machinery for Tablet and Pill Manufacturing and its regulations. This also provides specific regulations regarding production, sale, acquisition, importation, exportation, transportation, warehousing and distribution of certain chemical products, and apparatus for the manufacture of tablets and pills, specific permits and control and reporting requirements.
In 2017, diverse amendments to the Health Law were published, including amendments establishing the possibility to obtain MA for pharmaceutical products deriving from cannabis and a new law specifically regulating cannabis products is expected to be issued within the first months of 2021.xiv Enforcement
The Mexican health authorities may verify at any time the due compliance of applicable provisions of process involving these goods and services. COFEPRIS is generally in charge of these verification procedures, which must meet requirements in the Health Law and the Federal Law on Administrative Proceedings. These procedures must always be served in writing and the scope and purpose of the verification must be established clearly. Once such procedure notice is served, the authorities may initiate the review and verification of documents, premises and processes.
The verification procedures in health matters must meet the general guidelines and requirements for these types of matters included in the Constitution, Health Law and Federal Law on Administrative Proceedings.
All reviews and actions carried out by health authorities in these processes must be included in minutes and finalised with a written resolution in which the findings or potential infractions committed are set out. The determination of the commission of an infraction must always set out the factual background and legal basis upon which it is considered as such, and may be challenged through the applicable legal remedies.
During the current covid-19 pandemic, many verification processes and procedures have been put in the charge of the local health authorities of the different Mexican states. This has resulted in a number of procedures and legal remedies that have to be filed in accordance with local procedural provisions.