Mexico is an attractive market for US and Canadian suppliers of health products, and we wanted to share some thoughts on the Mexican market.
Generally speaking, Mexico is underrepresented in the world stage due to its (often unfair) misrepresentation in Hollywood. However, Mexico has the 15th largest nominal GDP and the 11th largest GDP by purchasing power. Given that Latin American countries are often thought of as developing nations, this is no small feat. It is estimated that by 2050, Mexico could become the world’s 5th or 7th largest economy and has been identified as an emerging world leader.
It is no question that Mexico has and will continue to become an important key player in the world’s economy, including the natural health product industry. According to Euromonitor International, the Latin American dietary supplement market experienced an average annual increase of almost 5% in 2013 (the second fastest in the world) and will reach US$5.5 Billion in sales by 2018; along with Brazil, Colombia and Venezuela, Mexico comprises approximately 85% of this massive market. It is no wonder that Canadian, American and European companies are looking to Mexico as a promising business development venture.
But just how easy is it to introduce your products to Mexico? Unlike Canada and the US, the importation of foreign-manufactured NHPs can be a real head-scratcher.
One of the biggest challenges to importation is product classification which is dependent on more than just formulation and intended marketing (including labeling). Classification is tightly linked to import taxes and is decided by customs and “arancelas” (the Harmonized code and tariff of products). Only after the proper arancela of a product has been correctly assessed and determined, can any regulatory paperwork be submitted to Cofepris (Comisión Federal para la Protección contra Riesgos Sanitarios) a branch of the Mexican Health Secretariat.
Because pre-market approval is mandatory for dietary supplements or “suplementos alimenticios,” obtaining the right permits is key. Import permits, media permits, product permits, labeling approvals – along with having the proper customs paperwork and be linked with the right customs agent, the list of requirements could be daunting.
Registration of products in Mexico also requires a local importer in Mexico, which should be identified prior to starting the product regulatory process.
NHP Consulting provides product and facility regulatory services for marketed health products in Mexico. Contact us to learn more and how we can help.