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New regulation on graphic and digitized prescriptions published in the Official Gazette

On September 2, 2023, exempt resolution No. 1,143 dated August 30, 2023 of the Ministry of Health was published in the Official Gazette, which establishes the new system for the validation of graphic prescriptions and the new guidelines for the prescription and dispensing of graphic and digitalized prescriptions.

The aforementioned implementations are framed within the framework of Law 21.267 and exempt resolution N°24 of 2021 of the Undersecretariat of Public Health, which enabled the dispensing of medicines with the exhibition of a copy of the prescription in digital or written format. Also, the aim is to guarantee an adequate use of the "Graphic Prescription Validation System" of the Ministry of Health, to allow the prescription of medicines related to remote medical consultations, in accordance with the provisions of Supreme Decree N°6 of 2022 of the Ministry of Health, which approves the regulation on actions related to remote health care.

Regarding definitions and guidelines for the correct use of the "Graphic Prescription Validation System", the regulations contemplate, among others, the following points:

  1. A distinction is made between the "Graphic Prescription Validation System" (hereinafter "Validation System"), which allows the capture of information contained in graphic prescriptions, assigning them a folio number and allowing their validation, and the "National Electronic Prescription System" (hereinafter "Electronic Prescription System"), which corresponds to a system for issuing and dispensing electronic prescriptions.
  2. It grants responsibility to the prescriber prior to the delivery of the withheld graphic prescription or check to the patient, its digitalization and folio in the Validation System.
  3. The pharmaceutical establishment must check the validity of the digitalized prescription prior to dispensing the products. The possibility of granting emergency folios to the prescriber for exceptional situations, such as rurality, technological availability, among others, is enabled.

Regarding the guidelines for the prescription of medicines associated with remote health care, the regulations cover, among others, the following points:

  1. The remote prescription of medicines whose condition of sale is a withheld prescription should preferably be made through the Electronic Prescription System.
  2. The remote prescription of medicines whose condition of sale is a check prescription, as long as there is no electronic check prescription, must be incorporated into the Validation System, and the prescriber is still obliged to send such prescriptions to the health authority.
  3. The dispensation may be made against any electronic prescription through the exhibition of a copy in physical or digital format, and the establishment, prior to the delivery of the medicine, must disable the prescription in the corresponding cases.
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