Sanitary Registration in Nicaragua

Posted by: Claraliz Oviedo Maglione| Associate at Alvarado y Asociados

The commitment to protect the health of citizens is not only the responsibility of the State through the health authorities, instead each manufacturer and distributor should assume a sense of responsibility, honesty and professionalism that can urge them to comply with all the legal provisions and processes established by the authorities to guarantee the sanitary quality and safety of the products offered in the market.

In Nicaragua, a sanitary registration is required for different types of products including: processed, unprocessed and semi-processed foods; processed beverages, alcoholic beverages, pharmaceuticals, cosmetics and hygiene products; medical devices, natural products obtained from plants, animals or minerals, which have specific therapeutic indications, nutritional supplements, among others.

Being aware that each of the products mentioned has a specific regulation, which is set forth in different Central American Technical Regulations, Nicaraguan Mandatory Technical Norms, laws related to the topic and other legal provisions, we will limit ourselves to pointing out some general information focusing on food products.

In general, a sanitary registration is a process that involves microbiological and physicochemicals examinations carried out by the sanitary authority to approve processed foods for commercialization. The same is obligatory for all those foods that requires transformation of raw material and have undergone a suitable technological process for its conservation.

Obtaining a sanitary registration as well as being an indispensable requirement for the commercialization of the product is precisely an intangible asset of the company as it add value to it and accredits compliance with current sanitary regulations, good manufacturing practices and quality standards.

Prior to any application for sanitary registration is essential that the establishment where the products are located, stored and produced is legally qualified and has the appropriate license issued by the relevant health authority. This authority is precisely the Ministry of Health through each of its Directorates and the Local System of Integral Health Care (SILAIS).

Once such license is obtained, the process for requesting health registration, which is relatively simple, can be initiated before the Ministry of Health through an application that includes:

  • Data of the holder: Name, identification document number, name of legal representative, exact address of the applicant, telephone (s), fax, email; exact address of the manufacturer or distributor, and the signature of the legal representative.
  • Data of the manufacturer: Name of the factory (as it appears in the license) indicating whether it is national or foreign, license or permit number and validity of the license or permit of the factory or warehouse, exact address, telephone, fax and email.
  • Data of the product: Name of the product to be register, brand, type, net content of the product and country of origin.
  • Additional documents: Copy of the sanitary license or current operating permit for the factory, for products of national manufacture or of the warehouse for products manufacture abroad; Certificate of free sale of origin or provenance, according to the legislation of each country, data sheet and original or draft label for imported and domestic products already on the market.
  • Samples: Samples to be submitted for analysis will depend on each product and the existence of Nicaraguan Obligatory Technical Standards. For example for food / processed beverages and food supplements, 3 samples of 500 grams each should be presented for solids and 3 samples of 1 liter each for liquids, these should come in their original packaging, be of the same lite and not close to be expired.

It should be noted that there are two additional procedures in relation to sanitary registrations, processes similar to the one mentioned above and with similar requirements: (i) Health Inscription: the applicant (importer or distributor) performs a clear identification and characterization of the product requesting the health authority to verify that the product is duly registered and that it has complied with the requirements, afterwards the applicant is registered as responsible for the product; and (ii) Recognition of registration: Process derived from Economic Integration Treaties through which each country accepts that a product that has been registered in another state party of the Central American Region may be marketed in its territory with the original registration number; being the validity of the recognition of registration the same as the period of validity that is indicated in the Certificate of Free Sale and that corresponds to the validity of the registration of the country of origin. In the latter process, the payment is made in concept of health surveillance derived from the recognition of registration, which is equivalent to the cost of sanitary registration in our country.

If there is a change in the information or conditions under which the registry was granted, it is important to notify the Ministry of Health as soon as possible. Changes accepted by the Ministry of Health include: (i) Change of business name of the applicant, (ii) Change of manufacturer's adress, (iii) Change in ingredients, (iv) Transfer of registration and (v) Change or Extension of brand or product name.

Undoubtedly, whatever motivates a distributor or manufacturer to obtain a sanitary registration at the end will represent numerous economic benefits, assuring greater possibilities for product placement, competitive ability and qualities that will allow in many cases to even enter an international market.

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