ANMAT Provision – No. 6223/2025
Health Department – Life Sciences Department Report | ANMAT Provision – No. 6223/2025
On September 3, 2025, Provision No. 6223/2025 (the “Provision”) was published in the Official Gazette. It was issued by the National Administration of Drugs, Food and Medical Technology (“ANMAT“) and introduces a new regulatory framework for the National Drug Traceability System (“SNT”) applicable to pharmaceutical specialties in Argentina. This regulatory update aims to strengthen the mechanisms for drug monitoring and control, prevent illegal trade and counterfeiting, and ensure transparency throughout the distribution and dispensing chain of pharmaceutical products.
As stated in the recitals of the Provision, since the implementation of the SNT in 201, and despite various regulatory measures adopted over the years, the last official list of Active Pharmaceutical Ingredients (“APIs”, or “IFAs” according to the Spanish acronym for Ingredientes Farmacéuticos Activos) subject to traceability had been approved in 2016. Consequently, based on the accumulated experience and the risk analysis related to fraud, counterfeiting, and illegal trade, the health authority deemed it appropriate to establish new objective inclusion and exclusion criteria to determine which APIs must be subject to traceability.
In this regard, Article 1 of the Provision approves the general guidelines defining the criteria for including or excluding APIs from the SNT (Annex I). According to this annex, APIs will be included in the SNT if they are part of pharmaceutical specialties with the following characteristics:
– Products or therapeutic groups subject to high surveillance and risk of counterfeiting, illegal trade, or fraud (e.g., oncology drugs, insulin, coagulation factors, among others);
– Treatments for rare diseases;
– Special regulatory registration pathways;
– Implantable pharmaceutical forms.
Conversely, APIs will be excluded from the SNT if they are part of pharmaceutical specialties that:
– Are sold over the counter;
– Are hospital-use presentations, unless classified as high surveillance and high-risk for counterfeiting, illegal trade, or fraud;
– Are radiopharmaceuticals;
– Have combinations or pharmaceutical forms not previously registered, where the active ingredients are not already subject to traceability individually (as single-drug products or in combination);
– Are used as contrast agents or in vivo diagnostic agents.
In line with the above, Article 2 of the Provision approves a new list of APIs required to be reported to the SNT, set forth in Annex II, which includes a total of 495 ingredients. This list applies both to products already registered and to those to be registered in the future, and will take into account any scientifically accepted synonyms, whether for single-drug products or combinations.
Holders of pharmaceutical specialties that contain any of the APIs listed in the new annex must comply with the Provision within forty-five (45) business days from its effective date.
In addition, any new pharmaceutical specialty registered with an API (or combination of APIs) not previously registered in the country must be subject to traceability from the time of its authorization, unless otherwise determined by ANMAT, in accordance with the defined technical criteria.
Complementarily, the Provision replaces the form for the Effective Marketing Authorization Report (previously approved by ANMAT Provision No. 3752/25) with a new version included as Annex III, which must be implemented immediately by the National Institute of Medicines (INAME).
The Provision also reinforces that all individuals and legal entities involved in the distribution, commercialization, and dispensing chain must continue complying with prior Provisions governing the SNT, including Provisions Nos. 3683/2011, 1831/2012, 247/2013, 963/2015, and 10.564/2016, in addition to the current Provision. It also clarifies that it is not mandatory to report logistics movements of pharmaceutical specialties that do not have a GTIN and serial number assigned by the marketing authorization holder.
Finally, the Provision expressly repeals Annexes I and II of ANMAT Provision No. 10.564/2016, which contained the previously applicable list of APIs, thereby consolidating a new regulatory basis for drug traceability in the country.
This Provision entered into force on the day following its publication in the Official Gazette.
Sincerely,