In Mexico, dietary supplements and vitamin medications are regulated federally by Cofepris, a subdivision of the Mexican Health Secretariat.
Products currently marketed in Canada as natural health products, or in the United States as dietary supplements, are most likely classified as either Dietary Supplements or Vitamin Medications in Mexico. Dietary supplements are classified based on their ingredients, dosage form, and daily dosage as defined within the Reglamento de Control Sanitario de Productos y Servicios (Regulations for Sanitary Control of Products and Services). Products classified within this category are subject to pre-market approval through the submission of a Permiso Sanitario (Sanitary Permit) application. On the other hand, vitamin medications are primarily classified based on the daily dosage of vitamins and minerals as defined by the Reglamento de Insumos para la Salud (Regulations for Health Products). Products in this category are subject to pre-market approval through the submission of a Registro Sanitario (Sanitary Registration) application.
While minimal documentation is required to demonstrate GMP for products manufactured in Canada and the U.S., import permits from companies in Mexico are still required. Licensed importers are also required to amend their importation license to list each product coming into Mexico. Finding a reputable Mexican importer is important in bringing products into the Mexico market.
Both types of application are subject to governmental assessment fees (set for each application type) and require the applicant to provide documentation to support safety and efficacy primarily through clinical, traditional and pharmacopoeial evidence for the ingredients within their product. Depending on the complexity of a product and how it is classified, the process may take anywhere between 1.5 and 9 months. All permits and registrations are made publicly available by Cofepris and are legally required prior to importation and market access.
While the complexity of this process may seem daunting, our company is committed to guiding our clients through this regulatory framework to gain access to the Mexican market. Our bilingual staff is ready to assist you, contact us to find out why we are Canada’s leading consulting firm and your ally in Mexican registration.
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