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Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has introduced a comprehensive update to its regulatory framework for imported medicines through Disposición 7998/2025, which establishes new procedures for certifying Good Manufacturing Practices (GMP) at foreign pharmaceutical plants.

The reform,accompanied by two detailed annexes, introduces a modern system designed to speed up certification while maintaining the highest standards of safety, quality, and transparency for medicines entering the Argentine market.

Harnessing Global Trust: Reliance and Risk-Based Evaluation

The new regulation allows ANMAT to apply Good Reliance Practices (GRP), a model promoted by the World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), to recognize inspection results and certifications issued by trusted foreign regulatory authorities.

This means that, depending on the country of origin and the inspecting authority, ANMAT can rely on verified GMP documentation rather than repeating inspections unnecessarily, reducing duplication and facilitating faster market access for compliant medicines. According to Annex I, titled “Guidelines for the Processing of GMP Certificates for Manufacturing Plants Located Abroad,” ANMAT will evaluate certification requests under a tiered, risk-based system:

• PIC/S Member Countries: Applications may include existing GMP certificates and inspection details.
• Authorities Recognized by PAHO/WHO: Plants inspected by national regulators rated Level III or IV by the Pan American Health Organization (PAHO) may apply using similar documentation, plus a Site Master File (SMF).
• MERCOSUR Members: Manufacturers within the regional trade bloc must provide certificates, inspection records, SMFs, and inspection histories.
• Other Countries: Facilities outside these frameworks will undergo direct verification or inspection by ANMAT before approval.

The Instituto Nacional de Medicamentos (INAME) will have 40 business days to review initial submissions and may require additional virtual or on-site inspections. Each certificate’s validity will depend on the risk analysis conducted, and companies must request recertification up to 60 business days before expiry.

New Standardized GMP Certificate

The newly approved Annex II presents a bilingual (Spanish–English) certificate format that will serve as the official proof of compliance. It includes the manufacturer’s name and address, the inspecting authority, the manufacturing processes covered, and the date of inspection. Each certificate includes a verification link to ANMAT’s official platform, Visor GEDO, enabling transparent public validation of authenticity.

A Modernized, Cooperative Regulatory Model

By adopting this updated certification system, ANMAT aligns with leading international regulators that emphasize collaboration and mutual recognition of inspections. The model supports global supply chain resilience, reduces inspection backlogs, and ensures that Argentina’s oversight remains rigorous yet adaptable to modern pharmaceutical realities. The new measure repeals Disposición ANMAT 2123/2005, replacing a 20-year-old procedure with one grounded in regulatory convergence, digital verification, and science-based decision-making.

Implications for Industry

Pharmaceutical companies exporting to Argentina will now benefit from clearer, harmonized certification criteria, faster evaluations for recognized authorities, and a more predictable renewal process. Further details are available in Disposicion here (in Spanish)

Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued Disposición 7939/2025, introducing a major reform to the authorisation process for cosmetic, personal care and hygiene product manufacturers.

Published in the Boletín Oficial de la República Argentina on 23 October 2025, the measure replaces the previous lengthy approval procedures with a digital sworn declaration system (Declaración Jurada), which confirms compliance with sanitary and manufacturing standards.

Simplified Authorisation

The new system applies to manufacturers or importers of

• Cosmetics and perfumes
• Personal hygiene products
• Oral hygiene items for dental use External disposable and intravaginal hygienic products
• Household cleaning goods (domisanitarios), except those considered high-risk

Companies will be authorised to operate once their sworn declaration is filed online, with ANMAT assigning a registration number. The declaration has no expiry date, but remains subject to inspection and compliance checks.

Updated Good Manufacturing Practices Rules

The reform introduces updated Good Manufacturing Practices (GMP) for disposable and intravaginal hygiene products, published as Annex II to the decree. The standards set out detailed requirements for infrastructure, hygiene, staff training, and record-keeping, covering every stage of production and storage. Manufacturers must ensure facilities are designed to minimise contamination, maintain strict environmental controls, and train staff in hygiene and safety protocols. Each product batch must undergo testing for microbiological safety, irritation, sensitisation and, where applicable, cytotoxicity.

Packaging must preserve product quality and include labelling in Spanish in line with national health rules. Claims of special product properties must be supported by scientific evidence. Companies outsourcing manufacturing processes must also formalise contracts detailing responsibilities and quality obligations, with both parties remaining subject to inspection.

Accountability and Oversight

While the new framework shifts Argentina towards self-declaration and digital compliance, ANMAT retains full authority to carry out audits and impose sanctions. Any false or incomplete declaration may result in suspension, fines, or legal penalties under Argentina’s public health laws. Existing companies must re-register under the new system within 180 business days, though they can continue using current packaging materials for up to three years. Activities involving higher-risk household chemical products will remain regulated under previous legislation.

Regulatory Renewal

The new framework repeals several older resolutions dating back to 1999, consolidating fragmented provisions into a single regulation.

Industry associations, including the Chamber of the Argentine Cosmetics and Perfume Industry (CAPA) and the Industrial Association of Personal and Household Care Products (ALPHA), were officially notified of the change.

ANMAT said the overhaul forms part of a broader government drive to modernise the public sector and align national standards with international best practice. The new regulation takes effect 60 working days after publication. For further details please consult the Decree here (in Spanish).