MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Imports of all pharmaceuticals and some medi- cal 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, includ- ing those imposed by the Ministry of Economy, the Ministry of Agriculture, Livestock and Natural Resources, the Ministry of Defence and the Fed- eral 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. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports In Mexico, non-tariff regulations and restric- tions – 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 exec- utive power may regulate or restrict the impor- tation or exportation of products, provided that Congress grants it such authority. The use of that authority needs to be approved by Con- gress at the end of each year.
for importing purposes and as a medical device from a regulatory perspective for commercialisa- tion 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 regula- tion to which the goods are subject, the follow- ing 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 Fed- eral 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 Agri- culture, 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 Import- ers’ 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 Import- ers’ Registry. This registration is subject to addi- tional requirements, which depend on the sector in which the importer is to be registered.
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