In Peru, pre-market approval of natural health products is overseen by DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), a branch of Peru’s Ministry of Health (Ministerio de Salud del Perú).
Markted health products are considered a subset of drugs and classified according to product formulation and intended use as either a subcategory of pharmaceutical products (Productos Farmacéuticos) or as subcategory of herbal products (Productos Galénicos) according to Decreto Supremo No. 010-97 SA and Ley No. 29459. These products legally require a Registro Sanitario(Sanitary Registration) prior to import and market access. Certain types of herbal products (or national origin and which carry no health claim or therapeutic, diagnostic or preventive uses) can be commercialized without a registro sanitario.
Sanitary registrations are granted for 5 years. Registered products must have compliant labels according to the limits set in their respective sanitary registrations. Applicants must provide evidence to support safety, efficacy and quality. Safety and efficacy are supported by pharmacopeial and traditional evidence (for products of herbal origin). Clinical evidence may be requested when pharmacopoeial evidence is not available. GMP certification required for importation. Products are imported via licensed importer but can be commercialized anywhere (no licensing required for stores).
NHP Consulting can successfully file regulatory documents ensuring product compliance for the Peruvian marketplace.
Contact us to learn more.