Numerous laws and regulations govern the import and marketing of medicines and medical devices in Mexico. In addition to purely regulatory and health-related requirements, a number of provisions which govern import procedures and products in general must be observed.
The main laws which regulate the marketing of medicines and medical devices are the General Health Law and the Health-Related Goods Regulations. Additional provisions regarding the particular technical issues associated with medicines and medical devices are included in Mexican official standards (NOM) and guidelines issued by the health authorities.
From a customs and foreign trade perspective, a considerable number of provisions govern the import of medicines and medical devices into Mexico, including:
- the Customs Law and its regulations;
- the Foreign Trade Law;
- the Federal Tax Code; and
- the General Administrative Guidelines on Foreign Trade Matters.
These provisions do not necessarily concern the characteristics, quality and safety of medicines and medical devices, but rather the actual process of importing them into Mexico for marketing purposes. Finally, various provisions also concern the import duties, taxes and costs associated with the import of medicines and medical devices for marketing purposes.
Parties that intend to import medicines and medical devices into Mexico should familiarise themselves with the full range of applicable requirements and obligations.
Most importantly, parties that want to market a medicine or medical device in Mexico (whether imported or manufactured domestically) must obtain the corresponding marketing authorisation from the health authorities.
Marketing authorisations are issued when the requesting party files the necessary documents with the health authorities and duly evidences that the medicine or medical device does not represent a health risk.
In addition, it is generally necessary to prove that the medicine or device meets all of the applicable legal requirements for its manufacture and marketing in its country of origin.
In general, applicants must provide the following information to obtain a marketing authorisation:
- technical and scientific data which duly evidences that the product is safe for human use;
- a product label (in Spanish) which complies with the specific requirements set out in the applicable NOM;
- instructions, prescription information and operating manuals (in Spanish);
- a general description of the manufacturing process and evidence of the manufacturing premises' regulatory compliance;
- a general description of the ingredients, raw materials, parts and components used in the product;
- a description and results of the laboratory tests and general dossier;
- a bibliography (if applicable);
- a free sale certificate or similar document issued by the health authorities in the country where the product is manufactured;
- good manufacturing practice certificates issued by the health authorities of the country of origin;
- a copy of the analysis certificate issued by the manufacturer;
- a copy of the authorisation to operate health-related goods premises and undertake health-related activities in Mexico; and
- proof of payment of the applicable government fees.
Once these basic requirements have been met, it is possible to import and market medical devices and medicines in Mexico.
To import any kind of product into Mexico, importers must register with the Treasury General Importer's Registry. Depending on the product's nature and tariff classification, they may also have to register with the Specific Sectors Importers' Registry.
Only authorised customs brokers (in-house or independent) can carry out the customs clearance procedure for importing goods into Mexico.
The applicable tariff classification must be determined prior to importing any kind of good into Mexico. This classification will determine the tariff and non-tariff requirements that must be met on import.
The import of goods into Mexico triggers import duties depending on the product and its tariff classification number.
In general, these duties are determined based on the product's customs value, which includes:
- the price paid to acquire the product;
- brokerage fees;
- transportation costs prior to import;
- insurance costs;
- storage, handling, loading and unloading costs; and
- any other costs incurred by the importer.
Import duties are determined based on:
- an ad valorem duty, which is a percentage of the product's customs value;
- a specific duty, which is determined based on the import volume; and
- mixed duties, which are a combination of the above.
Preferential import duty rates apply to products which originate from countries with which Mexico has a free trade agreement.
In addition, a customs processing fee of 0.8% of the product's customs value applies. This fee is generally payable only for products which originate from countries with which Mexico has a free trade agreement.
In some cases, dumping and countervailing duties also apply on imported products. These are determined based on the product's country of origin and specific tariff classification number.
In addition to the above duties and taxes, the import of goods into Mexico triggers value added tax (VAT). Although the applicable VAT rate for medicines is 0%, the general rate of 16% applies for medical devices.
In addition to the general and tariff requirements, diverse non-tariff requirements apply to the import of medicines and medical devices into Mexico.
Non-tariff requirements are determined based on the customs classification number of the product to be imported, as well as its specific nature as governed by the applicable legal provisions. The most common restrictions are as follows.
Import permits and licences
Medicines Medicines are generally subject to import permits, which are issued by the health authorities. In order to obtain such a permit, the requesting party must have a marketing authorisation.
Additional permits may be required in accordance with the tariff classification of the product or its components. For example, psychotropic and narcotic medicines may require authorisations in addition to a marketing authorisation and import permit.
Medical devices Medical devices are generally subject to fewer import permits and licences than medicines. In general, these products are subject to the presentation of the corresponding marketing authorisation on their import, but may also be subject to specific import permits depending on their nature, characteristics and classification (Class I-V).
Import quotas
An import quota is the prescribed amount of a certain product that can be imported into Mexico. It may be either:
- a maximum quota (ie, the total amount of a determined product that may be imported into Mexico during a set period); or
- an import duty quota (ie, the maximum amount that can be imported into Mexico under a specific import duty).
The Ministry of Economy may grant import quotas through either a public bidding procedure or a direct quota allocation. At present, no quotas apply to medicines or medical devices; however these may be implemented at any time if so determined by the health and trade authorities.
NOMs
NOMs are the minimum standards that all products, services and procedures must fulfil in order to be imported or marketed within Mexico. The purpose of such standards is to determine the terminology, classification, characteristics, qualities, measures, technical specifications and sampling and testing methods that apply to certain products, services or procedures.
Prior to the import of a foreign product subject to specific NOMs, a certificate or authorisation regarding compliance with such NOMs may be obtained from the competent government agency or authorised individuals or legal entities abroad.
In case of medicines and medical devices, it is generally not possible to obtain a marketing authorisation if the requesting entity does not evidence due compliance with the applicable NOMs.
Different requirements may apply in the case of hospital or medical equipment that is not expressly considered to be a medical device subject to a marketing authorisation.
Compliance with the above general requirements may pose a number of challenges. The most common issues faced by entities importing medicines or medical devices tend to concern:
- the tariff classification of goods;
- grey or parallel imports; and
- customs valuations.
For further information on this topic please contact José Alberto Campos Vargas at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
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