Mandatory Electronic Prescription: New Framework for Drug Prescriptions

1. Background and objectives

 

Emergency Decree 70/2023 dedicated an entire chapter to regulating digital and electronic prescriptions (Title XI, Chapter VI), and established its mandatory use by modifying Law 27553 on Electronic or Digital Prescriptions. Accordingly, Decree 345/2024—issued on April 22, 2024—provides the specifics for implementing electronic or digital prescriptions and sets July 1, 2024, as the implementation deadline.

 

2. Mandatory use of electronic prescriptions

 

Decree 345/2024 states that, as of July 1, 2024, electronic and/or digital prescriptions are mandatory for prescribing:

 

1. drugs,
2. tests,
3. medical practices,
4. any other indication that health professionals consider appropriate for their patients.

 

This regulation is meant to apply throughout Argentina, provided local jurisdictions adhere.

 

3. Exceptions

 

Annex II of Ministry of Health (MoH) Regulation 1959/2024 establishes a series of transitory and/or complementary conditions that act as exceptions to the general rule of mandatory electronic or digital prescriptions:

 

1. Paper, electronic, and/or digital prescriptions issued before July 1, 2024 will remain valid.
2. Paper, electronic, and/or digital prescriptions issued after July 1, 2024, and during the implementation period, may be valid according to the applicable schedules and rules.
3. Those platforms and/or systems implemented before July 1, 2024 that need adjustments according to the standards to be defined will remain valid, according to the applicable schedules and rules.

 

4. Content of the electronic prescription

 

The minimum content of the electronic prescription must be:

 

1. name and last name of the health professional,
2. profession,
3. license number,
4. address,
5. telephone number,
6. e-mail address, if applicable.

 

5. Registry of Electronic Prescriptions

 

Following Decree 345/2024, article 5, the recent MoH Regulation 1959/2024 created the National Registry of Digital Health Platforms (ReNaPDiS) and the Registry of Electronic Prescriptions, where all information systems and digital platforms related to digital health must be registered.

 

The systems and platforms that must be registered include:

 

1. prescription platforms and/or systems,
2. digital prescription repositories,
3. digital medication dictionaries,
4. telecare systems,
5. drug validation systems,
6. pharmacy administration systems,
7. any other system within the scope of digital health.

 

According to Regulation 1/2024 of the National Directorate of Health Information Systems, the platforms and/or systems that intend to register in the Registry of Electronic Prescriptions must do so within 120 days as of July 1, 2024.

 

Professionals and healthcare providers without a platform or system for electronic and/or digital prescription will have to adapt within an exceptional deadline of 180 days as of from July 1, 2024. 

 

6. E-Commerce

 

As a novelty, Decree 345/2024 states that, while the sale and dispensing of medications must be carried out from the pharmacy, if there is a responsible pharmacist, the sale and delivery of medicines to the patient may be arranged through electronic channels the pharmacy establishes, allowing medicines to be delivered to the location patients choose. The pharmacist will be responsible for ensuring that the delivery is carried out safely, in accordance with the applicable requirements, as well as any additional requirements the health authority determines.

 

7. Effective Date

 

Decree 345/2024 became enforceable on July 1, 2024. MoH Regulation 1959/2024 became enforceable on June 27, 2024.