National Executive Decree No. 1024/2024
Healthcare & Life Sciences Department Report |National Executive Decree No. 1024/2024
Dear All,
On November 19 of this year, Decree No. 1024/2024 (the “Decree”) was published in the Official Gazette, replacing Article 1 of the regulation of the Pharmacy Law, Law No. 17,565.
Article 1 of the previous regulation, Decree 7123 from 1968, was limited to referencing the ability of pharmacies to sell, in addition to the activities established by Law No. 17,565, products intended for personal hygiene or aesthetics, as well as those with prophylactic, disinfectant, insecticidal, or similar properties.
This Article 1 had already been modified earlier this year through Decree 345/2024, which added an additional paragraph specifying that the sale and dispensing of medications must be conducted at the pharmacy in the presence of a responsible pharmacist (Technical Director and/or auxiliary pharmacist) and that sales and deliveries could be arranged through electronic channels.
The new Decree aims to provide greater clarity on this matter, addressing both medications that require a prescription and those available for over-the-counter purchase.
To this end, the Decree modifies Article 1 of the Pharmacy Law regulations to specify that the sale and dispensing of “prescription medications” must take place at the pharmacy in the presence of a responsible pharmacist (Technical Director and/or auxiliary pharmacist). The parties may agree, through electronic channels, to both the sale and the delivery of medications to a mutually agreed location, provided that the delivery is carried out securely in compliance with applicable requirements and those established by the Health Authority for this purpose. This wording aligns closely with that of Decree 345/2024.
However, regarding over-the-counter medications, the Decree introduces a significant change to the current regime for displaying and dispensing these products: they may now be displayed on pharmacy shelves in a manner that ensures their physicochemical properties remain unaltered, allowing the public to access them directly without intermediaries.
When these products are displayed on shelves, the following requirements must be met:
-Shelves must be properly marked.
-Medications must be offered in sealed packaging with the corresponding leaflet and sold exclusively to individuals over 18 years of age.
The Decree further specifies that, in cases where over-the-counter medications are sold outside of pharmacies, sales will be limited to antacids and analgesics. Nonetheless, the Decree grants the Regulatory Authority the power to expand the range of over-the-counter medications permitted for sale in such establishments.
It is important to clarify that the Decree does not modify or repeal the requirements established by Decree 63/2024 regarding the sale of over-the-counter analgesics and antacids by non-pharmacy establishments.
The Resolution came into effect on the date the Decree was published.