Authorization of Special Law on Prices for services rendered by the National Directorate of Medicines
Made by: Licda. Virginia Vilanova
Regulatory Affairs and Life Sciences Manager of Romero Pineda
On September 18th, after the members of the Finance Committee of the Legislative Assembly listened to the presentation of the National Director of Medicines, The Special Law on Prices for services rendered by the National Directorate of Medicines (NDM) was approved by the Legislative Plenary, which increases the value and creates new fees for the procedures carried out before this institution.
One of the fees creates by this new law is the “annual surveillance maintenance fee”, which will help to carry out inspections at the points of sale of controlled products to ensure their safety, quality and efficacy, given that the NDM currently has less than 30 inspectors for all the pharmaceutical establishments in the country.
The new regulation will come into force on January 1st of 2024 and seeks to strengthen the work that the NDM performs in the quality control of the products protected by the Medicines Law, such as Medicines, Vitamin supplements, and natural products, medic devices, cosmetics, hygiene and chemical products.
Given that the National Directorate of Medicines is an autonomous institution that authorizes the registration, importation, manufacture, distribution and marketing of the aforementioned products, it needed to update its tariffs, to increase its operational capacity, invest in automation and digital services, promote the specialization of its staff, combat counterfeiting and piracy of products that can harm the health and integrity of the population, and as result of processing times of procedures.
The last objective is the one that, to a greater degree, caused the approval of trade associations such as the American Chamber of Commerce in El Salvador (AmCham) and the Association of Chemical-Pharmaceutical Industrialists of El Salvador, who were invited to the Finance Committee, given that it is intended to maintain El Salvador as the most efficient and effective sanitary authority in Central America.
Increase the capacity of the NDM and reduce the procedure times opens the opportunity for the new formers or developers to register their elaborations and this enter to the Salvadoran market, that will create more offer of products which can result in the prices reduction, that directly benefit to the Salvadoran population. The prices of the medicines have been regulated since 2013 by th NDM, that doesn’t permit an increment of them.
Comparison of some rates of the principal procedures:
| Procedure: | Year 2024 | Year 2025 | Year 2026 |
| New Registration / addition of alternate drug manufacturer | US$1,500.00 | US$1,500.00 | US$1,500.00 |
| Renewal of medicines | US$750.00 | US$1,125.00 | US$1,500.00 |
| Change of therapeutic indication, co-marketing, change of formulation, manufacturer and analytical methodology of drugs | US$120.00 | US$120.00 | US$120.00 |
| Other changes after drug registration | US$48.00 | US$48.00 | US$48.00 |
| Annuity fee and drug market surveillance | US$72.50 | US$108.75 | US$145.00 |
| New registration of cosmetics and hygienic products | US$240.00 | US$240.00 | US$240.00 |
| Renewal of cosmetics and hygienic products | US$120.00 | US$180.00 | US$240.00 |
| Other changes after the registration of cosmetics and hygienic products | US$48.00 | US$48.00 | US$48.00 |
| Cosmetics and hygienic products market surveillance and annuity fees | US$30.00 | US$45.00 | US$60.00 |
| New registration / addition of medical device codes and models (depending on the number of codes to be registered) | Between US$1,50.00 and US$1,440.00 | Between US$1,50.00 and US$1,440.00 | Between US$1,50.00 and US$1,440.00 |
| Renewal of medical devices (depending on the number of codes to be registered per application) | Between US$75.00 and US$720.00 | Between US$112.50 and US$1,080.00 | Between US$150.00 and US$1,440.00 |
| Modification in name or description of codes and models and others that may be aplicable for specific codes and models o medical devices (depending on the number of codes to be registered per application) | US$48.00 (base price) | US$48.00 (base price) | US$48.00 (base price) |
| Other modifications after the registration of medical devices | US$48.00 | US$48.00 | US$48.00 |
| Annuity fee and market surveillance for medical devices | US$55.00 | US$82.50 | US$110.00 |