MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
Under the Foreign Trade Law, Congress grants this authority to the executive power, with the condition that – in order for a non-tariff regulation or restriction to be imposed – the correspond- ing decree or administrative regulation must be published in the Federal Official Gazette , and the goods subject to such regulation or restric- tion must be listed by tariff classification and description. When products are subject to sanitary import permits, which in many cases require a mar- keting authorisation, if the product is subject to inspection upon customs clearance or after importation and the importer cannot demon- strate 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 Mexico has entered into 14 free trade agree- ments with more than 50 different countries. Mexico is an active party to the Pacific Alliance (along with Chile, Colombia and Peru). The Pacif- ic Alliance and its framework agreement have specific provisions on regulatory co-operation and product-specific annexes, covering cosmet- ics, medical devices, dietary supplements and cleaning products. This has started a very prom- ising regulatory harmonisation/convergence pro- cess in the region. Mexico is also party to the Comprehensive and Progressive Agreement for Trans-Pacific Part- nership (the revised Trans-Pacific Partnership value of the goods can be imposed. 7.5 Trade Blocs and Free Trade Agreements
Agreement), which contains promising provi- sions on the regulatory co-operation side, as well as product-specific annexes. The United States–Mexico–Canada Agreement (USMCA) entered into force in July 2020 and contains several regulatory annexes for phar- maceuticals, medical devices, chemical sub- stances, cosmetic products and food products. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices In Mexico, the private and public markets for medical products have separate rules depending on whether the products are patented. However, this mainly applies to pharmaceuticals and has changed during the new federal administration. The very general legislative bases of the dual system are contained in two laws: the GHL (Article 31) and the Federal Economic Compe- tition Law (Article 9). However, the rest of the rules are largely contained in separate regula- tory instruments of lower hierarchy, including the Addendum to the Agreement for Drug Pricing Co-ordination signed in 2004 between the Min- istry of Economy and the National Chamber of the Pharmaceutical Industry, and the technical standard for the labelling of drugs (NOM-072- SSA1-2012). Private Market Patented drugs for the private market are sub- ject to a hybrid system that is largely self-regu- lated and voluntary. Under this system, compa- nies compile their own information about their prices in other jurisdictions and submit that to
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