Regulation of the Electronic and Digital Prescription Law

On 27 February 2023, the National Executive Authority issued Decree 98/2023 (the “Decree”), published in the Official Gazette on 28 February 2023, regulating Law 27.553 on Electronic and Digital Prescriptions (the “Law”).

The Act was enacted in 2020, establishing that the prescription and dispensing of medicines and all other prescriptions could be written and signed through handwritten, electronic or digital signatures, on electronic or digital prescriptions, throughout the national territory, and that telehealth telecare platforms could be used in the same area.

Main points regulated in the Decree:

  • “Electronic Prescription” was defined as the digital document made and signed by a health professional, with electronic signature, through a platform that allows electronic prescribing.
  • The “Digital Prescription” was defined as a digital document, made and signed by a health professional, with digital signature and digital competence stamp, through a digital platform that allows such prescription.
  • The Ministry of Health shall be the implementing authority of the Electronic Prescription Law.
  • The Federal Health Licence (the “Licence”) was created, which will include all health professional licences registered in the “Federal Network of Health Professional Registries”.
  • Within the definition of “legally restricted sale” products (as established by Decree No. 7123/68), the possibility of prescribing them, in addition to in handwritten form, in electronic or digital form, always on officialised forms and in accordance with the model approved by the Ministry of Health, was incorporated into the definition.
  • It determined that for “prescription-on-file” products prescribed on electronic or digital prescriptions, the requirements set out in the Electronic Prescription Law must be complied with.
  • It determined that “prescription-only” products prescribed by electronic or digital prescriptions must be electronically or digitally signed by the Technical Directors and/or assistant pharmacists, when they contain magistral and official formulas, being responsible for their correct preparation.
  • Digital records and files shall be kept up to date and be made available and exhibited, where appropriate, to health authority inspectors upon request.

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