New Regulation of Sanitary Registration in Nicaragua

Apr 7, 2021 | English Blog

Recently, Administrative Resolution No. 0562-2021 of the Ministry of Health was issued, containing new conditions, requirements and procedures for the sanitary registration, renewal, subsequent modifications to the sanitary registry, import, distribution and commercialization of nutritional supplements, dietary supplements, nutritional supplements, food supplements and vitamin supplements.

To this date, the food sanitary records were processed before the Food and Beverage Regulation Directorate in compliance with all applicable legal provisions, such as: “General Health Law”, published in the  Official Gazette, number 91 of the May 17, 2002; Decree No. 001-2003, “Regulation of the General Health Law”, published in the Official Gazette, numbers 07 and 08 of January 10 and 13 of 2003 respectively; Central American Technical Regulation RTCA 67.01.02: 10, General Labeling of Previously Packaged Foods (Pre-packaged); and Specific Technical Standards according to the type of products.

Currently, given that the Administrative Resolution entered into force since its signature, on February 1, 2021, the authority responsible for evaluating the documentation to obtain the registration certificate and modifications of this category of is now a recently created Department called: “Department of Natural Handcrafted Products and Nutritional Supplements”, within the Pharmacy Directorate, instance of the Sanitary Regulation Directorate of the Ministry of Health.

According to this new regulation, the products will be considered “nutritional supplements, dietary supplements, nutritional supplements, food supplements and vitamin supplements”, when the concentrations of their components are equal to or less than those established in the Tables of Annex II of the Resolution; and in the event that the concentration of at least one of the components of the products described above is higher than those stipulated in the aforementioned Tables, it will be considered “pharmaceutical product” and must be registered in the Department of Sanitary Registration of the Directorate of Pharmacy in accordance with the requirements established in Resolution No. 333-2013 (COMIECO-LXVI).

In addition to the fact that the deadlines, requirements, official rates and the process in general changed significantly for the sanitary registration of such products, the essential aspect here is to proceed immediately to the analysis of the components included by the authority and the authorized concentrations, to make a comparison with the components of your product and determine if it could be classified as a pharmaceutical product. If your case is the latter, it is an essential requirement that you grant a Special Power of Attorney and carry out the due registration of a pharmaceutical professional to represent all your interests before this new Directorate, and be responsible for the registration, renewal and post-modification procedures. registration of your products.

You should bear in mind that this new regulation includes new requirements for the labeling of your products. The Technical Regulation on Labeling of Prepackaged Foods continues to be applicable; as well as with the Technical Regulation on Nutritional Labeling of Prepackaged Foods, however, you must additionally comply with the following:

  1. Contain truthful information regarding the product. These should not be described or presented using words, illustrations or other graphic representations that could give rise to false judgments about the nature, origin, composition or quality of the dietary supplement.
  2. Detail the composition by dosage form. In case it contains plants, their common name must be indicated, together with the scientific name and the part of the plant used. For supplements with Probiotics, indicate the scientific name and registration code of the bacteria, as well as the dose of the supplement. For the declaration of ingredient quantities, the units of measurement corresponding to the International System of Measurements must be used.
  3. Indicate the recommendation of maximum daily consumption, according to the commercial presentation of the nutritional supplement.
  4. Include the following Equivalent Legends or Phrases:
  5. “This product should not be used for the diagnosis, treatment, cure or prevention of any disease and does not supply a balanced diet”;
  6. “Do not use in pregnant women, in lactation period or in children” except those directed specifically for these populations, which must indicate the legend “Use under medical supervision”.
  7. “Keep out of reach of children”.
  8. The Nutritional Supplements that contain Tartrazine or yellow FDC number five, must indicate that they contain this colorant and include the legend: “Contains Tartrazine or yellow FDC five that can cause allergic reactions in sensitive people”;
  9. The Nutritional Supplements that contain the sweetener Aspartame, must include the legend: “Phenylketonuric contains Phenylalanine”.
  10. Products that contain Caffeine must quantify said ingredient and include the legend: “The consumption of this product is not recommended in people sensitive to Caffeine.”

For reference, you can find the costs for the right of sanitary registration and analysis in Art. 44 of Decree No. 23-2002, Reform of Decree No. 6-99, Regulation of Law No. 292, Law of Medicines and Pharmacy published the Official Gazette No. 46 of March 7, two thousand and two.

Now, if to date, you have products whose sanitary registration was processed before the Food and Beverage Regulation Directorate respectively, according to the requirements set forth before the Administrative Resolution came into force, according to the new provisions, you will be able to carry out its renewal and/or subsequent change in the “Department of Natural Handcrafted Products and Nutritional Supplements” at least three (3) months before the expiration of the granted registration. In this way, your product will still retain the authorized sanitary registration number, as long as you comply with the conditions, requirements and procedures in the newly issued Resolution. Additionally, you can continue with the importation of all products that have been registered with the Food and Beverage Regulation Directorate, while their sanitary registration is in force (up to one day before their expiration date), and will be authorized by the Directorate of Food and Beverage Regulation.

You can find Administrative Resolution No. 0562-2021 on the official website of the Nicaraguan Ministry of Health.