Decree 345/2024 dated April 19, 2024 (the “Decree”), amends the regulation of Law No. 27,553 on “Electronic or Digital Prescription of Medicines”, establishing the mandatory use of electronic and/or digital prescriptions as the means for the prescription of medicines, study orders, practices and any other indication that health professionals consider relevant for their patients, throughout the territory of the Argentine Republic and in coordination with the competent jurisdictional authorities and the relevant agencies with competence in the matter, as provided in Article 3 of the aforementioned Law No. 27,553.
Accordingly, the Decree also introduced amendments to the regulation of Law No. 17,565 on Pharmacies.
The Decree will become effective as from July 1, 2024.
Amendments to the regulations of Law No. 27,553
As regards the regulation of Law No. 27,553, approved by Decree No. 98 of February 27, 2023, item 7 on the identification of medicines was incorporated for the validity of the electronic prescription established in Article 1, subsection A) of the regulation, stating that the Enforcement Authority will implement an identification and reference instrument for medicines to be prescribed in electronic and/or digital prescriptions, in order to favor the use, access and interoperability of prescriptions. The implementation of this requirement will be progressively articulated by the Enforcement Authority, through the coordination with the competent jurisdictional authorities and the agencies with jurisdiction on the matter.
Likewise, subsection C) of Article 1 of the regulation was replaced, stating that the electronic and/or digital prescription is the mandatory means for prescribing medicines, orders for studies, practices and any other indication that health professionals consider relevant for their patients.
Accordingly, Article 2 of the regulation was replaced as follows: “All digital and/or electronic prescription and tele-prescription platforms shall comply with the legal requirements that regulate their exercise. Pharmacy management or dispensing systems or platforms shall allow the registration of the substitution of medicines at the time of dispensing, as well as shall facilitate the information to the prescriber on the substitution of the dispensed product or its partial dispensing. The implementation of this requirement shall be progressively articulated by the Enforcement Authority, through the coordination of its actions with the competent jurisdictional authorities and the agencies with jurisdiction on the matter, pursuant to the provisions of article 3 of Law No. 27,553”.
The jurisdictional authorities may adhere to the use of the ”Federal Health License”, the scope and content of which will be established by the complementary regulations issued by the Enforcement Authority, in order to implement the prescription of the digital or electronic prescription or the other practices defined by them in the “National Health Interoperability Network”.
In addition, subsection vi) of Article 3 of the regulation was replaced, establishing that the Ministry of Health, as enforcement authority, shall create the ”Electronic Prescription Record”, to which those responsible for the platforms and/or systems that have the technical capacity to prescribe electronic and/or digital prescriptions, orders for studies, practices and any other indication, shall inform the format and model of the prescriptions to be issued, as well as determine the required data based on the minimum fields in force in the Regulation of Law No. 17,132 on the practice of medicine and its amendments, define the requirements and procedures and audit their compliance.
Amendments to the regulation of Law No. 17,565
Regarding the current regulation of Law No. 17, 565, approved by Article 1 of Decree No. 7123 of November 15, 1968, as amended, it was added that the sale and dispensing of medicines must be carried out from the pharmacy, in the presence of a responsible pharmacist (technical director and/or auxiliary pharmacist), its sale and delivery to the patient may be agreed by electronic channels determined by the pharmacy, by means of a transfer to the place the latter may choose at its convenience, being the responsibility of the pharmacist to guarantee that the transfer is carried out in a safe way according to the applicable requirements and those established by the health authority for such purpose.
It should also be noted that article 6 of the regulation was modified by removing the requirement to present the medical prescription stating the need for the peremptory administration of the prescribed medicine for nighttime dispensing in case of emergency.
In turn, article 9 of the regulation was amended, introducing, for products sold under prescription, the requirements established in Law No. 27,553 and its regulation, referring to electronic and/or digital prescriptions. Likewise, it was introduced that electronic and/or digital prescriptions must be recorded in the digital file made available for such purpose once dispensed and signed electronically and/or digitally by the dispensing pharmacist, according to the form and procedure established by the Ministry of Health. The same procedure shall be followed by the technical director and/or auxiliary pharmacist with the magistral formulas dispensed, when the composition is integrated by the substances established under the condition of sale under prescription.
Likewise, when the products are dispensed under prescription, it was added that the technical directors and/or auxiliary pharmacists are obliged to sign electronically or digitally the prescriptions, when they contain magistral and official formulas, being responsible for their correct preparation.
Accordingly, Article 10 of the regulation was amended, establishing that the records and digital files must be kept up to date and must be made available and exhibited, as appropriate, to the inspectors of the Health Authority, at their request. The prescription record shall be signed daily by the technical director of the pharmacy at the end of the last prescription, guaranteeing its security, inalterability and completeness. The Enforcement Authority will determine and update the minimum requirements and contents that all digital files must have. Each pharmacy shall guarantee the existence of digital or electronic books of prescriptions, control of narcotic drugs, control of psychotropic drugs and inspections, according to the schedule established by the Enforcement Authority; having a substitute backup until such time as it is available in digital or electronic support.
