By: Olga Torres
Article written for issue #129 of the magazine Derecho y Negocios.
The sanitary registrations regulatory framework in the Central American region is diverse. It starts from general health laws that focus on the registration holders, pharmacies, distributors, and the sale of drugs to the public, to the different types of registration that are regulated in each of the countries.
Fortunately, several years ago, the Central American Technical Regulations (RTCA) came into force, with the technical regulation committees’ support and the achievement of the Sanitary Authorities of El Salvador, Guatemala, Honduras, Nicaragua, and Panama, have established the conditions for granting a sanitary registration in the Central American region. There are currently multiple RTCAs covering pharmaceutical, cosmetic, natural and food products, among others.
Let’s review these country regulations. In Nicaragua, Law No. 292, the Drugs and Pharmacies Law, regulates the formation of the Pharmacies Division in the Ministry of Health, donations, product registration, special guarantees that must be met, as well as permits for psychotropic products, among others. In 2022, Law 1068 was passed with the legal successor of the Pharmacy Division, which is now known as the National Health Regulation Authority (ANRS).
In El Salvador, after the creation of the National Directorate of Medicines (DNM), the country repealed some anachronistic laws that were no longer in line with the reality and sanitary registration needs, so the Law of Drugs and its regulations and the RTCAs were born, the main legal framework for making and obtaining sanitary registrations for renewals, changes and to regulate everything related to promotion and advertising. There is also a variety of rules and decrees that allow regulatory matters to be carried out under legal certainty.
In Guatemala there is a variety of dispersed norms that apply to sanitary registration, being the legal basis of the Health Code, the Congress of the Guatemalan Republic 90-97 Decree establishes which type of products prior must have a Sanitary Registration to their commercialization, as well as it indicates that the strengthening of the procedures in such matter will be carried out through International Treaties and Agreements, such is the case of the existing RTCAs. It also has a series of Ministerial Agreements, Decrees and Technical Standards.
through which the Ministry of Health emits administrative dispositions and procedures to the different sanitary registration procedures.
In Honduras are different regulations from the Health Code, Regulations for the Sanitary Control of products, services and establishments of sanitary interest, and different transitory regulations for applications for sanitary authorizations in the transition process that was used when the Health Regulation Agency was created in the country.
The Health Regulation Agency (ARSA) is the regulatory entity in Honduras in charge of carrying out the issuance of sanitary registrations of new cosmetics, pharmaceuticals, hygienic products, food and beverages, and any other product for human use and consumption; as well as in charge of ensuring compliance by establishments of sanitary interest, warehouses, factories where products are stored or distributed.
The region continues taking important steps to improve order, security and evolution of aspects of regulatory matters that require attention. In recent years we have witnessed how efforts are being made for pharmacovigilance, which are activities related to the detection, evaluation, understanding and adverse prevention reactions or any other health problem related to drugs or vaccines. In El Salvador it is done through the National Center of Pharmacovigilance; in Nicaragua through the Department of Pharmacovigilance of the ANRS; in Guatemala, the Department of Pharmacovigilance through the National Program of Pharmacovigilance -PNF; in Honduras among other countries that are joining this effort.
In Costa Rica we have the General Health Law, the RTCR and various provisions that regulate sanitary registrations and various decrees focused on the sale, transportation, marketing, and other products. The entity that registers products in Costa Rica is the Ministry of Health through a digital window called REGISTRELO where the registration and evaluation of sanitary products is performed.
Health Law is a broad branch of law that is recognized for its scientific autonomy over the areas related to life sciences in which other branches such as medical law, pharmaceutical law, biotechnological law, among others, are united. Let us hope that soon in the Central American region the legal instruments related to human health can be grouped, updated, improved and according to the current needs, for example, a pandemic such as covid19, where we have legal certainty as to the mechanisms of action that can be taken for the registration, importation, commercialization, and even the access of people to this type of pharmaceutical product.
In LatinAlliance we are very passionate about regulatory issues and we have more than thirty years of experience in the research and development sector, we have been at new legislation forefront and we wish to continue being a reference in the region.
