Dietary products must be registered in Peru for their manufacture, import, store, distribution, market, promotion, sell or use. The General Health Law (Ley General de Salud) - Law/Ley n° 26842, which is the overarching regulation for pharmaceutical products, establishes the requirements for sanitary registration.
The sanitary registration of dietary products is granted by name, pharmaceutical form, quantity of active ingredient (expressed in unit of dose or concentration), manufacturer and country.
The application for registration is made electronically, which is available on the website of the Ministry of Foreign Trade - MINCETUR: http://www.vuce.gob.pe.
Applications are evaluated by the Functional Unit of Biological, Natural, Dietary Products and other Pharmaceutical Products within 60 days.
For its evaluation, the requirements from the following regulations/lists should be met:
(i) Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products (Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos) approved by “Supreme Decree No. 016-2011-SA” and amendments;
- List of documents considered equivalent to the Certificate of Good Manufacturing Practices;
- List of warnings for the use of pharmaceutical and related products;
- List of competent authorities for the issuance of the Pharmaceutical Product Certificate or Certificate of Free Marketing of Products or Devices;
- List of vitamins, minerals and other nutrients allowed in the manufacture of dietary products;
- List of colours;
- List of excipients.
(ii) Dietary products are regulated under a separate section together with sweeteners, making that required documentation is different from what is required for pharmaceutical products. In accordance with “DS No. 016-2011-SA”, the required documentation is the following:
- Conditions for sale
- Label and leaflet (in Spanish)
- Formula
- Presentation forms
- Dose
- Lot identification
- Shelf life
- Information from producer and local applicant
- Specifications and analysis of active ingredients, excipients and finished product
- Specifications from packaging (direct and indirect)
- Stability data
- Certificate of free sale
- GMP certificate
- References, pharmacopeia
According to the result of the evaluation, the dietary product is either registered under a unique identification number called the “Sanitary Registration” (Registro Sanitario) or the application for product registration is denied.
The sanitary registration of dietary products is valid for 5 years, counted from the date of authorization of the sanitary registration, and may be renewed for equal and successive periods.
The fee for product registration is about USD 1000.
Products manufactured in the country for exclusive export purposes are exempt from this requirement.