- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
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*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products
In Central America there is the Central American Common Market (MCCA) made up of Costa Rica, El Salvador, Guatemala, Honduras and Nicaragua; The main objective is to unify the economies, jointly promote the development of Central America and improve the living conditions of its inhabitants. The General Treaty of Central American Economic Integration entered into force on June 4, 1961 for Guatemala, El Salvador and Nicaragua; on April 27, 1962 for Honduras and on September 23, 1963 for Costa Rica.
In Panama, food supplements or supplements have earned a place in the consumer medicine cabinet. Since 2006, all companies interested in importing food supplements or supplements must request a Sanitary Registry from the Panamanian Food Safety Authority (AUPSA), an entity created to take charge of the registration and authorization of all foods entering the country from now on.
If the supplement or food does not have the property to cure a specific disease, it could be considered as food, and it is the Panamanian Food Safety Authority where the “non-therapeutic” food supplements are presented, while the Ministry of Health would be in charge of the supplements “therapeutic” foods.
“Therapeutic” food supplements are considered drugs. For the purposes of this Law, dietary supplements are defined as a substance or mixture of substances intended to complement the nutrients normally present in food. Regarding the necessary requirements for the processing of the Sanitary Registry of vitamin, dietary and food supplements with “therapeutic” properties, they are established in the Regulations of the law on medicines and other products for human health.
In Costa Rica, the Ministry of Health considers B complex vitamins, glycerophosphates, soft extracts and caffeine as medicines; Vitamins, minerals and nutrients (dietary supplements) Dietary supplements include nutritional supplements based on proteins, carbohydrates, fats, vitamins and minerals to be consumed by people without special nutritional or therapeutic requirements.
In El Salvador, no specific legal instrument related to food supplements or dietary supplements is identified. Only the Health Code dictates that: It is attribution of the Superior Council of Public Health attached to the Ministry of Public Health and Social Assistance: Authorize the registration, importation, manufacture and sale of chemical-pharmaceutical specialties, vitamin supplements, food for special medical purposes, dietary supplements and products of animal and vegetable origin and other products or substances that offer a therapeutic action manufactured in the country or abroad, with or without a prior prescription and prior favorable report from the respective Boards and provided that they meet the requirements already specified in the corresponding regulation. The sale of the aforementioned products to the consumer may only be carried out in pharmacies and authorized sales of medicines as long as they meet the requirements already specified in the corresponding regulation.
In Nicaragua, the regulatory framework does not identify any specific legal instrument related to food supplements, food supplements, dietary supplements or vitamin supplements. However, they classify certain imported articles or merchandise as first and second category, in this sense, imported articles or merchandise are mentioned as first category, medicinal and pharmaceutical products, including Vitamins prepared exclusively from vitamins.
Despite the lack of specific regulation on the matter, complements or supplements are regularly marketed throughout the territory of the Republic under the condition of over-the-counter medication, consequently, its legal framework is based on the Law and the Regulation of medicines and pharmacies.
In Honduras, no specific legal instrument related to food supplements and dietary supplements is identified. Only the Regulation for the sanitary control of products, services and establishments of sanitary interest includes them within related products such as supplements and dietary supplements.
All food products, beverages, complements or supplements that are marketed or dispensed under a specific name require a Sanitary Registration issued by the Secretary of Health through the competent health authority.
In Guatemala, complements or supplements are considered a category of special products, however, their classification is dual, that is, they can be considered food or medicine. Officially the assigned name is dietary supplement product and its synonyms are: Food supplement, nutritional supplement and nutritional supplement. In the country, the regulatory body for supplements is the Ministry of Public Health and Social Assistance through the General Directorate of Health Regulation, Surveillance and Control.
They are defined as the substance or mixture of substances intended to complement the nutrients normally present in food. In a broad sense, these substances can be vitamins, minerals, amino acids, herbs or other substances or extracts of plant and even animal origin (gland extracts) even when their nutritional value has not been proven. In a strict sense, a dietary supplement is no longer considered as such and acquires the category of medicine when its labeling establishes that it is intended to prevent, treat or cure any disease. Normatively, there is the Law on the commercialization of essential generic medicines, medicines of natural origin and nutritional supplements or complements.
Supplements or nutritional supplements are those pharmaceutical products whose active substances are used to improve and optimize the functioning of the human organism, or to prevent health discomfort; The Ministry of Public Health supervises the quality of essential generic drugs, those of natural origin and nutritional supplements, offered to the public in coordination with the Guatemalan Standards Commission -COGUANOR- of the Ministry of Economy.
The technical and legal team of Aruna Asesores knows the regulations and is available to advise those interested in the commercialization of the products in CENTAM.
Check with our professionals online or get frequent questions about registration processes in different countries
Check with our professionals online or get frequent questions about registration processes in different countries
