Through Decree 63/2024 (the “Decree”), the President incorporated new modifications and supplemented those already provided by Decree 70/2023 regarding the commercialization of medicines, including both over-the-counter and prescription only medicines.
The main aspects considered by the Decree are the following:
- If a healthcare professional (HCP) recommends or suggests the use of a particular medication by prescribing its brand or trade name, the pharmacist is obligated, at the patient or consumer’s request, to substitute the medication for one of lower price, provided it contains the same active ingredients, concentration, pharmaceutical form, and a similar quantity of units as prescribed.
- Authorized pharmacists will be the only ones permitted to dispense prescription only medicine, as well as to modify medicines for others with similar conditions.
- The Decree introduces a model of electronic and/or digital prescription.
- The only over-the-counter medications that can be dispensed outside authorized pharmacies will be antacids and analgesics, which must be placed or displayed in a way that the public cannot access directly to them, consequently, they must be handed over by an employee of the establishment and only to individuals aged eighteen (18) or older.
- Establishments which are not authorized as pharmacies and intend to dispense over-the-counter medicines must obtain authorization from the enforcement authority, which will be subject to certain requirements:
- A report certifying ownership, or right of usufruct, or lease or loan agreement for the property in accordance with current legislation.
- An insurance policy covering risks related to the sale of pharmaceutical products for a minimum insured amount equivalent to seven hundred fifty (750) minimum, vital, and mobile salaries.
- A storage space for the medicinal specialties, separate and independent from other products sold by the establishment, secured and meeting the conditions of hygiene, safety, cleanliness, spaciousness, light, and adequate ventilation as determined by the Enforcement Authority.
- The maximum temperature of the establishment must not exceed twenty-four (24) degrees celsius.
- The division of the primary and secondary packaging is prohibited in all cases.
- Drugstores may exclusively dispense prescriptions for oncological or special treatment medications listed by the regulatory authority to the public.
- ANMAT (National Administration of Drugs, Foods, and Medical Devices) may incorporate other active pharmaceutical ingredients (IFA for Spanish acronym), as a single drug or in combination or fixed-dose combination, for bioequivalence/bioavailability studies, and establish exceptions based on scientific evidence and/or recommendations from the World Health Organization and/or the Pan American Health Organization.
