MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
in turn have an 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 Gen- eral Direction of Standards; • the Federal Consumer Protection Agency ( Procura- duría 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. 7.2 Importer of Record of Pharmaceuticals and Medical Devices 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 Ser- vice. 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. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Imports of all pharmaceuticals and some medical devices are subject to the obligation of securing spe- cific 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 Agricul- ture, Livestock and Natural Resources, the Ministry
of Defence and the Federal Commission of Telecom- munications. Among others, the following exceptions to the obliga- tion 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. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports 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 execu- tive 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 – 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 authorisa- tion, if the product is subject to inspection upon cus- toms 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.
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