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Special Law on Prices for Services of the National Drug Directorate
[/vc_column_text][us_separator][vc_column_text] On September 18, 2023, the Legislative Assembly, through the Finance Commission, issued a favorable opinion for the approval of the “Special Law on Prices for Services of the National Drug DirectorateIn order to strengthen the functioning and guarantee the effectiveness and legality of the Registry of pharmaceutical, cosmetic and hygiene products, medical devices, and chemicals. The new Law updates all the fees that the National Directorate of Medicines applies for services and other activities provided for the procedures carried out by pharmaceutical companies in the country. It includes the changes proposed by the DNM (National Directorate of Medicines), as well as the regulations for the entry into force of the collection of said fees. These fees will be applied gradually starting January 1, 2024, in relation to health registration renewals and annual maintenance fees. Initially, they will increase by 50% of the fee, then by 75% starting January 1, 2025, and then by 100% starting January 1, 2026. This law seeks to strengthen institutions that protect the pharmaceutical sector by guaranteeing the institutional framework that allows for the accessibility, registration, quality, availability, efficiency, and safety of pharmaceuticals and cosmetic products. Therefore, it will allow the National Directorate of Pharmaceuticals (DNM) to exercise better quality controls on products and to increase the surveillance of pharmaceuticals circulating in the country to combat counterfeiting. This will result in increased productivity of the DNM in ensuring that products released to the market do not pose a risk to the health of the population and that companies can be served promptly to continue leading good practices in the sector at the regional level. The regulations will also determine the prices for service fees, product licenses, and establishments regulated by the DNM. Additionally, it includes exemption from paying the fees provided for by law for all national public institutions, including the Salvadoran Social Security Institute (ISSS), as well as for natural or legal persons who, with prior authorization from the DNM, provide duly authorized and free healthcare services. Likewise, procedures related to orphan drugs, procedures submitted by patients when the drug or medical device is not on the market, and the importation of items for personal use will be exempt from payment when the amount of the fee does not exceed the value of one current monthly minimum wage in the commerce and services sector. This law will also apply to non-profit institutions that provide health services, such as churches, municipalities with free or low-cost clinics and pharmacies. One of the new fees that the institution will charge will be the annual maintenance fee for market surveillance, valued at $35 for cosmetic products and $100.00 for medical products. These fees will apply only to registered, imported, or domestically manufactured products being marketed in the country. The additional cost of the new fees will be borne by the companies, not by consumers, so there will be no increase in the cost of medications. To better understand the new rates, we invite our customers and the general public to contact us so we can provide the advice and support they need in processing their applications with the health authorities. [/vc_column_text][us_separator][vc_column_text]Written by: Lexincorp El Salvador [/vc_column_text][/vc_column][/vc_row]
