Resolution of the Ministry of Health – No. 2214/2025
Healthcare & Life Sciences Department Report | Resolution of the Ministry of Health – No. 2214/2025.
Dear all,
On July 21, 2025, Resolution No. 2214/2025 (the “Resolution“) was published in the Official Gazette, through which the Ministry of Health of the Nation established the comprehensive regulatory framework for the electronic or digital prescription of medicines, medical devices, complementary studies, practices, and procedures throughout the national health system.
The Resolution issued in the context of Law No. 27,553 on Electronic or Digital Prescriptions and its Regulatory Decree No. 98/2023, as well as complementary regulations, consolidates a comprehensive policy of electronic prescription, guaranteeing security, interoperability, traceability, confidentiality and inclusion in the management of digital prescriptions.
The main aspects and new features introduced by the Resolution and its Annexes are detailed below:
1-Scope and Types of Prescription
The electronic or digital prescription covers not only medicines, but also medical devices, supplies, study orders, practices and medical procedures. Prescription is understood to be a health document, created and signed by a licensed health professional, for a patient, and which is subject to regulatory and technical requirements. Annex I of this Resolution establishes three types of prescription:
-Prescription of medicines: For dispensing in authorized pharmacies or authorized establishments. Commonly this is the type of prescription known as a “prescription”.
-Prescription of medical devices: Includes products such as glasses, orthopedic devices, supplies for medication administration, among others, for outpatient or community use.
-Prescription of complementary studies, practices and/or procedures: Intended for the provision of health services to a patient on an outpatient basis. It includes clinical analyses, diagnostic imaging, specialized consultations, kinesiotherapy sessions, psychotherapy, among others.
2-Prescription Subtypes and Conditions of Dispensing
Depending on the condition of dispensing the medicine, the following subtypes of prescription are defined:
-Free sale
-Sale by prescription
-Sale under archived prescription
a-Electronic prescriptions replace printed copies, since their authenticity and traceability are guaranteed by the digital signature and registration in the system.
b-Prescriptions for antibiotics, psychotropic drugs (Schedules III and IV) and narcotics (Schedule III) are subject to specific control due to their health risk.
c-They must be registered in the pharmacy’s digital prescription book, under the responsibility of the technical director.
d-The systems must be adapted within 90 days to allow the registration and access of these prescriptions by the control authorities.
-Legally restricted sales
a-Each jurisdiction must authorize professionals to prescribe narcotics and report such authorization to the Federal Registry of Health Professionals (“REFEPS”). This, in order to keep information updated at the national level, facilitate the validation of prescriptions and strengthen control and traceability mechanisms in the use of medicines subject to control.
b-This register will incorporate a specific field to verify this authorization, which will be mandatorily validated by the prescribing software before issuing prescriptions for legally restricted dispensing.
c-Prescriptions for psychotropic drugs (Schedule II) and narcotics (Schedules I and II) must be registered in the digital recipe book and be available for inspection.
d-120 calendar days are granted from entry into force for the systems and jurisdictions to implement the necessary changes.
The condition of sale is determined by the National Administration of Drugs, Food and Medical Technology (“ANMAT“). and the Ministry, in accordance with current regulations (Law 16,463 -Medicines-, Law 17,565 -Pharmacies-, Law 27,680 – Prevention and control of resistance to Antimicrobials-, Law 19,303 -Psychotropics-, Law 17,818 -Narcotics- and its regulations, amendments and supplements).
3-Mandatory Digital Format and Repositories
All prescriptions must be issued exclusively in electronic or digital format through platforms registered in the National Registry of Digital Health Platforms (“ReNaPDiS”).
The platforms that act as repositories must be registered in the ReNaPDiS and safeguard the information of the prescriptions in digital files for a minimum period of three years for archived prescriptions and legally restricted dispensing. In addition, they must guarantee access to the competent health authorities.
4-Structure and Content of Electronic Prescription
Electronic or digital prescriptions must contain, at a minimum, the following information:
-Professional block: Name and surname, profession, Federal Health License (“REFEPS Code”), registration number, issuing entity, jurisdiction, specialty (if applicable), professional address, electronic or digital signature, and authorization for psychotropics/narcotics (when applicable).
-Patient block: Name and surname, DNI, CUIL (or CUIT/CDI/passport for foreigners), date of birth, sex, health coverage (if applicable), address (mandatory for legally restricted sale).
-Prescription block: Clear and complete description of what is prescribed, diagnosis, date of start of validity, date of preparation.
-Drug block: Active Pharmaceutical Ingredient (API), presentation, pharmaceutical form, number of units, commercial suggestion (optional).
-Unique Prescription Identification Code (CUIR): Unique, unrepeatable and secure identifier for each prescription, which allows the traceability, authenticity and security of information throughout the national territory. The CUIR is composed of the following modules:
1-Identifier of the prescribing platform (4 digits)
2-Repository ID (4 digits)
3-Jurisdiction identifier (2 digits, according to INDEC coding)
4-Identifier of the type of prescription and condition of sale (4 digits)
5-Unique prescription group identifier (up to 25 digits)
6-Prescription item number (2 digits)
-Barcode or QR: To facilitate traceability and control.
Annex III of the Resolution, together with this previously detailed information, also establishes a standardized display model for electronic prescriptions, in order to ensure a homogeneous and legible presentation. This model defines the graphical structure, the order of the blocks and the hierarchy of the mandatory data. Although the recipe is a structured digital document, this format makes it easy to read and print when needed. This model must be respected to ensure consistency, clarity and transparency in its presentation.
5-Technical and Interoperability Standards
The Resolution establishes regulatory and technical bases to guarantee the interoperability, security and quality of electronic or digital prescriptions throughout the country. Given the decentralized nature of the health system, unified standards are defined to guarantee quality, safety, traceability and correct identification of the actors involved. Semantic, syntactic and security standards are adopted in line with international standards and adapted to the national context. The National Directorate of Health Information Systems (“DNSISA“), will be the authority in charge of establishing and updating these guidelines, promoting a reliable and sustainable digital infrastructure.
-Semantic standards: ensure that clinical information has the same meaning across systems, practitioners, and organizations. To do this, they use coded terminologies and vocabularies that enable uniform interpretation of data across the digital health ecosystem.
-Syntactic standards: define how data is organized and transmitted between systems, and the FHIR language is adopted as an exchange format for its ability to facilitate interoperability and the efficient flow of information.
-Security standards: Protocols and technological mechanisms to ensure the secure, authentic, confidential and traceable transmission of information. Its implementation must follow the recommendations and good practices defined by the DNSISA.
6-Adaptation Deadlines
Health service providers, platforms and systems must adapt to the provisions of the Resolution within a period of up to 45 calendar days from its entry into force, except for the specific deadlines provided for the digitization of prescriptions subject to special inspection (90 or 120 days depending on the case).
7-Updating Powers
The Undersecretariat of Epidemiological Surveillance, Health Information and Statistics and the National Directorate of Health Information Systems are empowered to update the technical annexes and issue complementary administrative acts for the implementation of the measure.
This measure will be applicable to all agencies and entities that are within the orbit of the Ministry of Health. The authorities and ministerial representatives shall adopt the provisions for the implementation of this measure.
The Resolution entered into force today.
Sincerely,