Decree No. 63/2024: clarifications on the modifications to laws No. 25,649, No. 17,565, and No. 17,132 introduced in DNU No. 70/2023.
Healthcare & Life Sciences Department Report | Decree No. 63/2024: clarifications on the modifications to laws No. 25,649, No. 17,565, and No. 17,132 introduced in DNU No. 70/2023
Dear Sir or Madam,
Decree No. 63/2024 (the “Decree”), published in the Official Gazette on January 22nd, 2023, modifies certain aspects of the regulatory decrees of the so-called Generic Drugs Law (No. 25,649), Pharmacy Law (No. 17,565), and the Law on the Practice of Medicine (No. 17,132). This aims to clarify certain modifications introduced by the so-called “mega-decree” No. 70/2023 (“DNU”).
I. Prescription of Medications by Generic Name
The aforementioned DNU had removed from the Generic Drugs Law the possibility for health professionals to indicate the commercial brand of the medication they were prescribing.
Conversely, the Decree clarifies that in cases where the health professional records the suggestion of a name or commercial brand, the pharmacist, at the patient’s request, must replace it with a cheaper one that contains the same active ingredients, concentration, pharmaceutical form, and a similar number of units as prescribed.
II. Electronic Prescriptions
The DNU eliminated handwritten medical prescriptions, leaving only the possibility of electronic or digital prescriptions. The Decree establishes the content that electronic prescriptions must have, including:
(i) Patient information;
(ii) Medication (generic name or international common denomination, presentation, pharmaceutical form, and quantity of units);
(iii) Suggestion of commercial brand – in line with the point above–;
(iv) Diagnosis.
III. Dispensation of Medications
In line with the modifications mentioned so far, the Decree reaffirms that the pharmacist is the only responsible and qualified individual for the proper dispensation of medicinal specialties that require prescriptions, as well as for their substitution.
IV. Over-the-Counter Medications
The DNU removed over-the-counter medications from the Pharmacy Law, so pharmacies lost exclusivity in the sale, dispensation, and distribution of this category of medications.
The Decree, on the other hand, establishes limitations on the sale of this category of medications outside pharmacies. In this sense, it indicates that establishments not authorized as pharmacies may only sell within the over-the-counter medications category of antacids and analgesics.
Furthermore, it establishes that to do so, they must obtain authorization for which they must meet certain requirements, including but not limited to presenting certain documentation: (i) a report that verifies ownership, or right of usufruct, or lease or loan agreement on the property in accordance with current legislation; (ii) an insurance policy that covers risks of selling pharmaceutical products for a minimum insured sum equivalent to 750 minimum, vital, and mobile wages, (iii) having a space to store medicinal specialties, separate and independent from other products sold by the establishment, secured under lock and key, and meeting the conditions of hygiene, safety, cleanliness, space, light, and adequate ventilation as determined by the Application Authority, (iv) over-the-counter medications in establishments that are not pharmacies must be located or displayed in such a way that the public cannot directly access them, and must be delivered by an employee of the said establishment, (v) the maximum temperature of the establishment must not exceed 24 degrees Celsius.
V. Drugstores
By the DNU, drugstores that obtained the corresponding authorization were enabled to dispense medications to the public. Regarding this, the Decree clarifies that drugstores may only dispatch to the public prescriptions that prescribe oncological medications or special treatments listed by the application authority, thus limiting the dispensation of any other type of medication.
If you have any queries, please do not hesitate to contact us.
Sincerely,
Ana Andrés