ANMAT Provision No. 754/2025
Health Law – Life Sciences Report | ANMAT Provision No. 754/2025
January 30, 2025, the Official Gazette published Provision 754/2025 (the “Provision”), through which the National Administration of Drugs, Food, and Medical Technology (“ANMAT”) has established a new specific regulatory framework for the availability and commercialization of medicinal specialties registered in the Register of Medicinal Specialties (“REM”).
The Provision expands upon and adds certain concepts applicable to the previous regulation, Provision 2038/2017 (the “Previous Regulation”), introducing modifications regarding notification deadlines, updates to the National Drug Formulary (“VNM”), and measures to be taken in cases of product discontinuation.
Below are the main differences compared to the previous regulation:
1- Incorporation of Regulatory Definitions
Like the Previous Regulation, the Provision maintains the obligation for holders of certificates registered in the REM, classified as commercialized, to notify ANMAT of any known facts or circumstances that could jeopardize product availability and lead to temporary or permanent discontinuation in the supply chain.
However, unlike the Previous Regulation, Section 2 of the Provision introduces a set of definitions that were not previously included, such as “Availability,” “Discontinuation or Shortage,” “Temporary Discontinuation,” “Permanent Discontinuation,” and “Retention Samples.”
The objective is to provide a clearer interpretation of regulatory obligations.
2- Notifications
The 180-day advance notice requirement remains in place for laboratories holding registrations of medicinal specialties in the REM that decide to permanently discontinue commercialization.
As a new measure compared to the Previous Regulation, the Provision introduces the use of the “Trámites a Distancia” (“TAD”) platform of the Electronic Document Management System (“GDE”) for receiving information on the availability of medicines in the supply chain.
3- Temporary Discontinuation
Regarding temporary discontinuation, the Provision defines this concept as:
“When a medicinal specialty is unavailable in the supply chain for a specific period, with an estimated date for reintroduction into the supply chain.”
It is important to highlight that the Provision establishes that discontinuation cannot exceed 45 consecutive days. If this period is exceeded, the holder must request a change in status to “non-commercialized.”
The date of product reintroduction into the supply chain must be reported. From the specified date, the product will regain its commercialized status in the VMN application. This update must be carried out via TAD.
4- Measures for Drug Discontinuation
Section 12 introduces the possibility for holders of registered medicinal specialties to request exceptional authorization, in cases of temporary or permanent discontinuation, to distribute valid retention samples to patients to ensure continuity of treatment. This process must also be managed through TAD.
5- Obligation to Update Data
Holders of certificates registered in the REM are required to update information on drug availability within 30 calendar days from the publication of the Provision.
The Provision came into effect the day after its publication in the Official Gazette.
Sincerely,