In Colombia, natural health products / dietary supplements are overseen by Invima, (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) a branch of Colombia’s Ministry of Health and Social Protection (Ministerio de Salud y Proteccion Social).
Most health supplements can be classified as either Dietary Supplements (Suplementos Dietarios) regulated under Decreto Numero 3249 de 2006 or as Phyto-therapeutic products (Fitoterapéuticos) regulated under Decreto Number 2266 de 2004. Product classification is dependent on formulation, intended use, daily dosage and dosage form. Invima oversees pre-market approval through the submission of Sanitary Registration (Registros Sanitarios) applications as regulated according to Decreto Numero 677 de 1995. Sanitary Registrations, when approved, are granted for a period of 10 years. Evidence to support safety, efficacy and quality (including GMP standards) is submitted as part of the application process. Sanitary registrations are issued to the specific activity to be conducted for a product (import and sale, manufacturing and sale, import, manufacturing, etc.). Two modalities are possible for one registration if needed (import or manufacturing and sale). Registered products are given clearance for import through a licensed importer; this company is responsible for the distribution of registered products to licensed stores (stores where product will be sold which are also subject to Invima certification separately).
International Trade Certificates (ITC) certifying Canadian and U.S. manufacturer GMP status are sufficient to meet quality requirements. Evidence to support safety and efficacy is primarily clinical and pharmacopoeial; traditional evidence is acceptable for products within Colombia that are known to have traditional uses. Traditional texts also accepted depending on preparation for certain sub-classes of phyto-therapeutic product applications. Registered products are subject to labeling requirements depending on product classification; appropriate intended uses (based on product evidence) are acceptable and will be accompanied by risk information statements.
NHP Consulting can successfully file regulatory documents ensuring product compliance for the Colombian marketplace.
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