Regulatory Considerations in the Requirements of the Sanitary Registration of Dietetic Products in Peru
Author: Q.F. Ana Susana Rojas Avalos
The Dietetic Product is that product whose purpose is to supplement the normal diet consisting of concentrated sources of nutrients or other substances that have a nutritional or physiological effect, in simple or combined and dosed form. And that are only used for oral use, according to the definition cited in Supreme Decree 016-2011-SA and its amendments: “Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products”, through Annex N° 01 “Glossary of Terms and definitions”.
It is important to mention that, although dietetic products do not have a pharmacological action, they are classified as Pharmaceutical Products; therefore, their sanitary registration is the jurisdiction of the General Directorate of Medicines, Supplies and Drugs (DIGEMID), as the Peruvian regulatory entity of these medicines.
According to Law N° 29459 “Law of Pharmaceutical Products, Medical Devices and Health Products”, the sanitary registration of a product entitles its holder to manufacture, import, store, distribute, commercialize, promote, dispense, sell or use them, in the conditions established in this Regulation.
Supreme Decree 016-2011-SA and its amendments, mentioned above, establish that the sanitary registration of dietetic products is granted by name, pharmaceutical form, amount of Active Ingredient (expressed in dosage unit or concentration), manufacturer and country. DIGEMID grants the sanitary registration valid for five-years, counted from the date of authorization of the sanitary registration, which can be renewed for equal and successive periods.
Currently, the application of registration is made electronically, through the Single Window for Foreign Trade (VUCE), available on the website of the Ministry of Foreign Trade – MINCETUR, for this purpose, the applicant must have the Sanitary Authorization in force as a Pharmaceutical Establishment (Laboratory or Drugstore), granted by the same DIGEMID.
Then, the requirements for obtaining the Sanitary Registration of dietetic products are mentioned, which are established through Supreme Decree 016-2017-SA, which modified the initial Article 93° of the “Regulation for the Registration, Control and Sanitary Surveillance of Pharmaceutical Products, Medical Devices and Health Products”, these are presented with a brief commentary with recommendations to present some of the requirements for the registration of this type of products:
1. Application as a sworn statement; within the sworn statement for the application of sanitary registration, technical data are requested to be requested to the manufacturer of the dietetic product, or to be extracted from the technical dossier, without considering this information as a documentary requirement to be attached, among these technical data the following can be mentioned:
– Qualitative and quantitative formula, which must be declared in units of weight or volume of the metric system or in recognized international units, including all excipients and solvents, even if the solvents disappear in the manufacturing process.
– In addition, the Peruvian standard also mentions that, for these products, if the active ingredient is found in the form of salt or hydrate, but is active as a base, acid or anhydrous, the amount of both presentations of the active ingredient must be declared.
– Technical references, whether pharmacopoeia or in-house, both of the active ingredient(s) as well as of the excipients.
– The type of primary and secondary packaging.
– The primary and secondary packaging material.
– Forms of product presentation.
– The lot code system, with which the dietetic product will be imported into Peru.
2. Technical specifications of the finished product; if the product has as reference “in-house”, the Peruvian standard for these products does not request the validation of the analytical technique to be attached.
3. Stability studies or document issued by the manufacturer that supports the shelf life of the product; being currently acceptable to include a duly signed letter from the manufacturer, where the data of the dietetic product is detailed, mentioning the shelf life, as well as the storage conditions and detailing the pack-closure system of the dietetic product.
4. Draft artworks in Spanish language of the packaging, primary and secondary; taking into account that for this requirement it should be considered primarily that these should not consign properties of prevention, treatment or cure of a disease, nor images that induce an inappropriate use. The general information that must be considered in the primary and secondary artworks of dietetic products is contemplated in Article 96° of Supreme Decree 016-2011-SA and its amendments. We can equate the information demanded for medicinal products, considering some specific differences for the secondary artwork in this type of products:
– The dosage of the product recommended for daily consumption (for dietetic products), for which the table of Dietary Reference Intakes or the limits considered in High Sanitary Surveillance Countries for this type of products is important. It can be mentioned that this data becomes a reason for observations by the DIGEMID, being that the regulatory authority appropriately safeguards that the components are not used above the allowed limits, since they could generate an undesired effect.
– Recommendations for use or enforcement.
– Indicate “Dietary supplement” or “Nutritional supplement”.
– Include the warning not to exceed the daily dose expressly recommended for dietetic products.
– The express statement that dietetic products should not be used as a substitute for a balanced diet.
Although the draft insert is not a mandatory requirement for dietetic products, Peruvian regulations establish that in case it is not possible to include all the information required in the secondary artwork, it should be included in an attached insert, except for the name of the product, name and country of the manufacturing laboratory, lot number, sanitary registration number and expiration date.
5. Free Sale Certificate (FSC) issued by the competent Authority of the country of origin or of the exporter. Although the regulation mentions that a FSC preferably following the WHO model should be considered, the Peruvian regulatory authority is not discriminating against other models. However, it is important to consider that if the FSC does not include the product formula or the name of the product to be marketed in Peru, a letter from the manufacturer must be submitted, including the name of the product to be marketed in the country and/or the qualitative and quantitative composition of the product.
6. Certificate of Good Manufacturing Practices (GMP) of the manufacturer. In the case of products manufactured in Peru, which have an in force GMP issued by DIGEMID, it will be sufficient to consign the number of the manufacturer’s GMP certificate issued by DIGEMID.
Among the documents equivalent to the GMP Certificate, in the event that the applicant wants to register a dietetic product from a manufacturer whose country does not issue a GMP certificate, the following should be considered:
– CPP as equivalent to GMP Certificate, not FSC.
– Certification Document.
– ISO Certificates.
– HACCP Certificates.
– Attestation for exportation.
– Certificate of Manufacture and Free Sale.
Additionally, for the sanitary registration of dietetic products in Peru, it is important to keep in mind that vitamins, minerals and other nutrients approved by the DIGEMID can be used in their manufacture, through the list that is published and updated periodically, which according to the regulations is based on lists approved by High Sanitary Surveillance Countries. For reference, it is mentioned that the last updated and published document in Peru for this point is the one approved through Directorial Resolution N° 025-2022-DIGEMID-DG-MINSA “List of Vitamins, Minerals and Other Nutrients Permitted in the Manufacture of Dietetic Products”.
In the case of dietetic products containing vitamins, minerals and/or other nutrients that are not in the list established by DIGEMID, Supreme Decree 016-2011-SA and its amendments, establishes that the applicant must additionally submit scientific information that justifies the use of such raw materials, duly supporting their safety and efficacy.
In addition, Peruvian regulations for dietetic products also state that these products can be combined with natural resources of vegetable, animal and/or mineral origin that have nutritional properties.
Finally, it is important to mention that the evaluation of dietetic products is given in a shorter time, comparing its evaluation with that of medicinal product; thus Supreme Decree 016-2017-SA, states that it must be given in 30 days, although in practice it can become a longer time, depending on whether the application for sanitary registration presents observations.
In summary, the regulatory management of dietetic products must take into account that in Peru, the application of registration requirements has particular considerations that seek to respond to the same definition of dietetic products as per Peruvian regulations as well as their adaptation to the international regulatory context of this type of products, which are not always classified as pharmaceutical products in all countries, but are also included in other categories of products regulated by the health authorities.