ANMAT Provision – No. 3752/2025
Healthcare & Life Sciences Department Report | ANMAT Provision – No. 3752/2025.
Dear all,
On May 30, 2025, Provision No. 3752/2025 (the “Provision“) was published in the Official Gazette, through which the National Administration of Drugs, Food and Medical Technology (“ANMAT“) established a new regulatory framework for the effective commercialization authorization of medicinal specialties of synthetic and/or semi-synthetic origin. This regulatory update aims to optimize regulatory processes, strengthen oversight and guarantee the safety, efficacy and quality of the products that are commercialized in the country.
In this sense, the Provision introduces the following main aspects and new features:
1- Definition and Scope of Effective Commercialization Authorization
The Provision defines “Effective Commercialization Authorization” as the regulatory process of technical evaluation, control and inspection of the first productive batch of a medicinal specialty registered in the Registry of Medicinal Specialties (“REM”), carried out by the Health Authority to verify the technical, productive and analytical capacity of the owner of the product.
This procedure will be applied to:
A-New synthetic and/or semi-synthetic products, in all their pharmaceutical forms and concentrations, registered in the REM.
B-New concentrations of products registered and already commercialized, when the qualitative composition of their formulation differs from the composition of the concentration of the medicinal specialty that has the Effective Commercialization Authorization.
C-New concentrations of registered and already commercialized products with the same qualitative composition but the quantitative composition is not proportional to the formulation of the medicinal specialty that has the Effective Commercialization Authorization.
D-New pharmaceutical forms of products registered in the REM.
E-New concentrations of products registered and already marketed with Active Pharmaceutical Ingredients (APIs) that require Bioequivalence.
F-Transfers of certificates for pharmaceutical forms that present evidence of marketing and that do not have the Effective Commercialization Authorization
G-Products with interrupted marketing for 5 years or more, that do not have the Effective Marketing Authorization.
H-Certificates acquired at judicial action.
2-Types of Established Procedures
The Provision introduces three different processing modalities:
1-Effective Commercialization Authorization Procedure: Applicable to the cases established in paragraphs A), D), E), and H) above.
2-Simplified Procedure for Effective Commercialization Authorization: For cases established in paragraphs B), C), F), and G) above, and for products whose condition of sale is over-the-counter.
3-Procedure for Exemption from Effective Commercialization Authorization: applicable for i) transfers of certificates for pharmaceutical forms that already have effective authorization and ii) new concentrations or concentrations not marketed until the time of starting the process of pharmaceutical forms of products without requirements for demonstration of Bioequivalence that have the Effective Commercialization Authorization, with an equivalent method of preparation and control whose qualitative-quantitative composition is proportional to the formulations that already have the aforementioned authorization.
3-Inspections and Controls
ANMAT may carry out face-to-face or virtual inspections, request reanalysis and take samples at any stage of the procedure, both in ordinary and simplified procedures.
4-Procedure and Documentation
The Provision states that at the time of initiating the application for Effective Commercialization Authorization, no procedure related to the product in question should be pending.
In addition, it approves the “Effective Commercialization Authorization Procedure” and the documentation required for each type of procedure, which are detailed in Annexes I and II of the regulation.
In addition to this, it is clarified that the application must be made through the Remote Procedures Platform (“TAD”), and that all the information submitted will be in the nature of an affidavit.
5-Issuance and Notification of the Authorization Report
The Effective Commercialization Authorization will be granted by the National Directorate of the National Institute of Medicines (“INAME”) through the ” Effective Commercialization Authorization Report”, which will be notified to the applicant and to the Directorate of Technical Information Management (“DGIT”). Once incorporated into the National Medicines Vademecum (“VNM”), the product will be enabled for commercialization.
6-Sanctions and Special Considerations
The Provision establishes that the commercialization of medicinal specialties without the prior issuance of the Effective Commercialization Authorization Report will be considered illegitimate, and will make the holder of the certificate subject to the sanctions provided for in Law No. 16,463 and Decree No. 341/92.
In cases of health emergency or situations that require expedited authorization, ANMAT may arbitrate the means to issue it in a shorter period than usual.
In turn, it is provided that, if the evaluation of the application for Effective Commercialization Authorization is unfavorable, the National Directorate of INAME will prepare a well-founded report and will send the proceedings, together with the draft denial act, to the Directorate of Legal Affairs for its opinion. Subsequently, the Coordination of Verification of Positive Acts will submit the project to the National Administration for signature.
7-Validity and Repeal of Previous Regulations
The Provision expressly repeals ANMAT Provisions No. 9707/2019 and 7438/2010, and establishes that the procedures in progress at the time of its entry into force will continue under the previous regime until its conclusion.
This Provision entered into force on the day following its publication in the Official Gazette.
Sincerely,