Currently the countries are committed to seek mechanisms to ensure high quality standards of products sold, and therefore, the Sanitary regulatory issue has become much more demanding in terms of creating appropriate regulations and processes to obtain an authorization.
The nature of the product will determine the applicable health regulations and accordingly, such nature will designate the entity/authority that will be responsible for the registration and surveillance in each country. In order to support the growth of certain business sectors, international regulations have been created whose purpose is to harmonize requirements for obtaining Sanitary Registrations in various countries; specifically in the Central America region there are many Central American Technical Regulations (Reglamentos Técnicos Centraomericanos) in force.
With respect to El Salvador, while it is true that the applicable regulation has evolved considerably, our challenge is to achieve shorter response times in obtaining Sanitary Registrations from institutions/authorities, without avoid involving prerequisites.
In El Salvador, the entities/authorities responsible for the registration of the main products that deserve Sanitary Registrations are:
National Bureau of Medicines (Dirección Nacional de Medicamentos): Registration of pharmaceuticals, natural products, nutritional supplements, cosmetics, hygiene and medical supplies.
Ministry of Health and Welfare: Registration of food products for human consumption, including alcoholic beverages.
Ministry of Agriculture: Registration of veterinary products, including animal feeds; insecticides and the like.
In practice it often happens that many companies, by ignorance or trying to save money, make the mistake of assigning the management of Sanitary Registrations to people who have no knowledge or experience in the field, the result -in most cases- the issuance of many objections/observations that greatly expand the paperwork and make it almost impossible to obtain Sanitary Registrations, causing significant losses for companies, because they cannot enter the market with their products by the lack of Sanitary Registration, although they already have all the logistics for market sales.
In addition to the Sanitary Registrations becoming a prerequisite for the operation of industries like pharmaceutical, food, veterinary, etc, it represents an intangible asset. Sanitary Registrations are the guarantee for the Company accrediting that the products offered in the market are suitable and meet the appropriate quality standards for commercialization.
However Sanitary Registrations are territorial, especially for some cases, you can choose to apply for more expedite processes covered by the law, to help get Sanitary Registrations in less time; eg homologation processes/registration recognitions.
Companies can no longer address the issue of Sanitary Registrations as a mere filing, but on the contrary, they require the appropriate counseling and intervention of a Lawyer in Sanitary Registration matters, to avoid setbacks that hinder the possibility to commercialize their products in a given market.
José Manuel Argüello
CENTRAL LAW El Salvador.