February 26, 2025

GMP Compliance for Regulated Product Manufacturing in Argentina
Argentina is the eighth largest country in the world. While it has experienced some internal challenges that affect the regulatory process, Argentina has laid a well-considered, national and international compliance framework. Argentina could prove to be a significant force in regulated production worldwide.
Here is a breakdown of compliance regulations:

Pharmaceuticals, Biotech & similar industries
Argentinean GMP for drugs and the like are governed by a combination of national regulations and international standards. The primary regulatory agency is the National Administration of Drug, Foods, and Medical Devices (ANMAT). ANMAT is responsible for the regulation and supervision of pharmaceutical manufacturing. Law 16.463 establishes the requirements for medication manufacturing, distribution, and sales. Decree 150/1992 outlines the specifics of these requirements.

• The ANMAT drug approval process is phased, and parallels most other world standards.
• ANMAT also issue dispositions that are regularly updated to reflect advances in technology and world best practices.

Like other national agencies, ANMAT conducts inspections of pharmaceutical production facilities and documentation practices and will issue a hierarchy of penalties for noncompliance.
Argentina also adheres in the international standards for GMP compliance, primarily by the World Health Organization (WHO)and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Dietary Supplements
AMVAT regulates supplements through Food Code Chapter XVII and Article 1381.  The Food Code lists the additives that are allowed in end products. AMVAT requires marketing authorizations for these products; they are valid for 5 years.

Cannabis
Medical use cannabis was legalized in 2017. Additionally, a bill was signed in 2020 that allowed medical patient to grow their own to reduce costs. This bill included regulations for cultivation, processing, and distribution of cannabis for medical purposes.
CBD, like cannabis, is legal for medical use only. It is regulated though the National Health Surveillance Agency (ANVISA )with Brazil .

Recreational cannabis remans illegal at this writing, although possession has been decriminalized, and some specific regions allow small amounts.

E-liquids
ANMAT and the Argentine Ministry of Health prohibit vaping products.
InstantGMP provide systems that support the requirements of AMVAT, including Inventory and Electronic Batch Records. Our systems and  website are  now available in Spanish. For more information visit us at www.instantGMP.com Respaldamos Su Calidad

References
AMVAT  www.argentina.gob.ar/anmat
Paige, Melanie, “Is Weed Legal in Argentina?” www.mycannabis.com, 2025
www.ecigator.com