The estimated time for phase (2) is two months. Phase (1) legal deadline is 90 days, but in practice, it takes about 4 months. Registrations consists of two phases, (1) obtaining a food supplement classification letter and (2) obtaining a food supplement advertising permit.
The advertising of food supplement requires a permit granted by the Federal Commission for Protection against Health Risks (COFEPRIS), as regulated by NOM 251, numeral 6.7.Īdvertising of food supplements that do not have an advertising permit is subject to the sanctions provided for in the General Health Law. Proof of payment of fee (5,201.47 MXN, around 215 USD).Chemical and microbiological analysis for each batch.Health certificate or certificate of free sales from the country of origin.For imported supplements, product registration is required (Permiso sanitario previo de importación).(i) Registration requirements for imported products The manufacturers must notify the “Federal Commission for Protection against Health Risks (COFEPRIS)” through an “Operation Notice (Aviso de funcionamiento)”, at least 30 days before starting their operations.
The requirements for the marketing of national supplements is more lenient, where only the production facilities must be notified. REGISTRATION REQUIREMENTS FOR NATIONAL PRODUCTS
