Argentine GMP Guide for Medicines
Argentina's current Good Manufacturing Practices guide for manufacturers and importers/exporters of human-use medicines (Disposición ANMAT 4159/2023). It consolidates and replaces the earlier dispositions (2819/04, 3602/18, 3827/18, 1281/19) and is built on WHO, PIC/S, ICH, and ISO guidance. Argentina has been a PIC/S member since 2008.
Manufacturers and importers/exporters of human-use medicines supplying the Argentine market. The guide provides the general GMP framework enforced by ANMAT inspectorates.
- 01Follow the PIC/S-aligned GMP guide for human-use medicines
- 02Maintain qualification and validation lifecycle records
- 03Apply PQS and contamination-control expectations
Published in the Boletín Oficial on 16 June 2023, repealing Dispositions 2819/04, 3602/18, 3827/18 and 1281/19.
ANMAT Disposición 4159/2023: frequently asked questions
Quick answers to common questions about ANMAT Disposición 4159/2023.
What is ANMAT Disposición 4159/2023?
ANMAT Disposición 4159/2023 — Argentine GMP Guide for Medicines — is a regulation issued by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (Argentina). Argentina's current Good Manufacturing Practices guide for manufacturers and importers/exporters of human-use medicines (Disposición ANMAT 4159/2023). It consolidates and replaces the earlier dispositions (2819/04, 3602/18, 3827/18, 1281/19) and is built on WHO, PIC/S, ICH, and ISO guidance. Argentina has been a PIC/S member since 2008.
Who does ANMAT Disposición 4159/2023 apply to?
Manufacturers and importers/exporters of human-use medicines supplying the Argentine market. The guide provides the general GMP framework enforced by ANMAT inspectorates.
What are the key requirements of ANMAT Disposición 4159/2023?
ANMAT Disposición 4159/2023 requires, among other things: Follow the PIC/S-aligned GMP guide for human-use medicines; Maintain qualification and validation lifecycle records; Apply PQS and contamination-control expectations.
When was ANMAT Disposición 4159/2023 last updated?
The current version of ANMAT Disposición 4159/2023 dates from June 2023. Published in the Boletín Oficial on 16 June 2023, repealing Dispositions 2819/04, 3602/18, 3827/18 and 1281/19.
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When ANMAT Disposición 4159/2023 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.