By: Olga Torres
Article written for issue #129 of Law and Business magazine
The regulatory framework for carrying out sanitary registries in the Central American region is diverse. It starts from general health laws that concentrate the actions of the registration holders, pharmacies, distributors and the sale of medicines to the general public to the various types of registration that are regulated in each of the countries.
Fortunately, several years ago the Central American Technical Regulation (RTCA) came into force, which with the efforts of the technical regulation committees and the achievement of the Health Authorities of El Salvador, Guatemala, Honduras, Nicaragua and Panama have established the conditions to grant A sanitary registry in the Central American region.
The RTCAs are currently multiple and cover pharmaceutical, cosmetic, natural, and food products, among others.
Let's review the regulations in each of the countries, in Nicaragua it is Law No. 292 Law on Medicines and Pharmacies that regulates from the formation of the Pharmacy Division in the Ministry of Health, going through donations, product registration, special guarantees that permits for psychotropic drugs, among others, must be complied with. In the year 2022 Law 1068 arose with the legal successor of the Pharmacy Division with what 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In El Salvador, after the creation of the National Directorate of Medicines (DNM), the country repealed a series of anachronistic laws that were no longer in accordance with the reality and necessity of health records, thus the Medicines Law and its regulations and the RTCA is the main legal framework for carrying out and obtaining health records, for renewals, changes and for regulating everything related to promotion and advertising. There is also a variety of regulations and decrees that allow regulatory matters to be carried out under legal certainty.
In Guatemala, there are a variety of dispersed regulations applicable to sanitary registration, the legal basis being the Health Code, Decree 90-97 of the Congress of the Republic of Guatemala, which establishes what type of products must have prior to their commercialization. with Sanitary Registry, as well as it indicates that the strengthening of the procedures in this matter will be carried out through International Treaties and Agreements, such is the case of the existing RTCA. Likewise, it has a series of Ministerial Agreements, Decrees and Technical Standards, through which the Ministry of Health issues administrative provisions and procedures applicable to the various sanitary registration procedures.
In Honduras there are different regulations related to the field of health, ranging from the Health Code, Regulations for the Sanitary Control of products, services and establishments of sanitary interest, and different transitory regulations for requests for sanitary authorizations in the transition process that was used when the Health Regulation Agency was created in the country.
The Sanitary Regulation Agency (ARSA) is the regulatory entity in Honduras in charge of carrying out the issuance of sanitary registries for new cosmetics, pharmaceuticals, hygienics, 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 to take important steps towards the ordering, certainty 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 prevention of adverse reactions or any other health problem related to medicines or vaccines. In El Salvador it is carried out through the National Pharmacovigilance Center; in Nicaragua through the ANRS Pharmacovigilance Department; in Guatemala, the Department of Pharmacovigilance through the National Pharmacovigilance Program -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 health records and various decrees focused on the sale, transportation, marketing and other products. The entity that registers the products in Costa Rica is the Ministry of Health that through a digital window called REGISTRELO where the registration and evaluation of sanitary products is carried out.
Health Law is broad and is a branch of law to which its scientific autonomy is recognized over areas related to life sciences in which other branches such as medical law, pharmaceutical law, biotechnological law, among others, come together. others. We hope soon that in the Central American region the legal instruments related to human health can be brought together, updated, improved and in accordance with current needs, for example, a pandemic such as covid19, where we have legal certainty in regarding the mechanisms of action that can be had for the registration, importation, commercialization and even the access of people to this type of pharmaceutical products.
At LatinAlliance we are passionate about regulatory issues and we have more than thirty years of experience in the research and development sector. We have been the spearhead for new legislation and we want to continue being a benchmark in the region.
