Argentina Regulatory News

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 ca...

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).

Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has introduced a comprehensive update to its regulatory framework for imported medicines through Disposi...

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 has introduced sweeping changes to the way pesticides and other plant protection products are approved, imported and labelled. The National Service of Agri-Food Health and Quality (SENASA) ...

Argentina has introduced sweeping changes to the way pesticides and other plant protection products are approved, imported and labelled. The National Service of Agri-Food Health and Quality (SENASA) issued Resolution 458/2025, replacing more than a decade of previous rules. The new regulation creates a single national registry for agrochemicals, strengthens oversight of imports, and makes compliance with the United Nations Globally Harmonized System (GHS) for chemical classification mandatory.

National Registry

Under the reform, a National Registry of Plant Protection Products has been established, consolidating existing pesticide registrations into a single system. Companies seeking to register products will now rely primarily on sworn declarations (declaraciones juradas) for approval, subject to subsequent audits by SENASA. Trials, field tests, and experimental use, however, will still require prior authorisation. The government says the shift is designed to reduce bureaucratic delays while maintaining strict controls to protect public health and the environment.

Import Controls and “Convergence” Countries

The resolution introduces a two-tiered approach to pesticide imports, distinguishing between countries with “regulatory convergence” and those without.

• Imports from nations such as the European Union, United States, Brazil and Japan will benefit from a simplified, fast-track registration system. In some cases, provisional registrations lasting up to two years will be permitted.

• Imports from non-convergent countries must undergo full evaluation, including new efficacy trials and toxicological assessments.

Mandatory Global Harmonised System (GHS) Labels

One of the most significant changes is the mandatory adoption of the UN’s GHS system for chemical labelling and classification.

• All pesticide products must comply with the 9th edition of the GHS “Purple Book”, covering hazard categories, pictograms and safety information.

• Companies have three years to bring existing products into compliance

This brings Argentina closer to global chemical safety standards already adopted in much of Latin America, the EU and the US.

Reevaluation Powers and Environmental Safeguards

The resolution also grants SENASA expanded powers to re-evaluate pesticide approvals if new scientific data emerges or if products show unexpected environmental risks, resistance problems or residue concerns. Such reviews may result in tighter restrictions, lower maximum residue limits (MRLs), modifications of approved uses, or even outright cancellations.

Broader Context

Argentina is one of the world’s largest exporters of soybeans, maize and wheat, and among the top consumers of pesticides in Latin America. The regulatory overhaul comes as neighbouring countries, including Brazil and Chile, update their own pesticide frameworks. SENASA is seeking to modernise and unify the country’s pesticide laws under a single, internationally aligned framework.

Timeline

• 25 September 2025 — Resolution enters into force, 90 days after publication.

• September 2028 — Final deadline for all products to comply with GHS classification and labelling.

For more information, you can find the Resolution here (in Spanish). 

Argentina has introduced a new regulatory framework for managing the import, export, and transit of recycled non-hazardous waste. The new measures, outlined in Resolution 393/2025, are aimed at protec...

Argentina has introduced a new regulatory framework for managing the import, export, and transit of recycled non-hazardous waste. The new measures, outlined in Resolution 393/2025, are aimed at protecting the environment, ensuring compliance with international waste management treaties, and advancing the country’s circular economy.

The resolution is based on Decree 1/2025, which establishes guidelines for the handling of non-hazardous waste, specifically materials that have undergone a recovery process to be used as inputs for industrial processes or as direct-use products. These materials must meet strict environmental standards, and the resolution creates clear procedures to regulate their movement across Argentina’s borders.

Structure of the Regulation

Resolution 393/2025 includes four annexes. Annex IV defines the eligible non-hazardous recovered materials, while Annexes I, II and III outline the procedures for import, transit and export. All applications must be submitted through the Trámites a Distancia (TAD) platform and undergo technical evaluations, customs checks and compliance reviews.

The Basel Convention plays a central role in this framework, ensuring that materials moving across borders meet international environmental standards. In addition, all documents will be validated through Argentina's Single Window for Foreign Trade (VUCEA) and Malvina system to streamline processing and ensure robust oversight.

Annex I - Import Procedures (365 Day Authorisation)

To import non-hazardous waste, businesses must submit a sworn declaration through the TAD platform, detailing the material’s origin, composition, recovery process, intended use, and confirmation of its non-hazardous status. The Dirección Nacional de Residuos (National Waste Directorate) will assess whether the waste matches the list in Annex IV and complies with both national and international regulations. If approved, the Subsecretary of Environment will issue an authorisation valid for 365 days.

Annex II - Transit Procedures (90-Day Authorisation per Shipment)

For materials transiting Argentina en route to a third country, exporters must file a similar declaration outlining the shipment's route, estimated quantities, transport companies, and insurance details. Proof that the destination country permits the importation is also required. Transit permits are valid for 90 days, and each shipment must be treated individually.

Annex III - Export Procedures (365-Day Authorization)

Exporters must provide detailed documentation on the waste's origin, recovery process, and destination. They must also demonstrate that the material is not classified as hazardous under the Basel Convention or is recognised as raw material by the importing country. If no objections are raised within 10 working days, the export is automatically authorised, and the permit remains valid for 365 days.

Annex IV - List of Non-Hazardous Wastes

This annex defines what types of materials are considered non-hazardous. These include:

• Scrap metals (iron, steel, etc.)
• Certain glass waste (excluding hazardous or radioactive glass)
• Paper and cardboard waste
• Animal and vegetable oils
• Uncontaminated metal or non-plastic containers
• Selected textiles and untreated wood
• Plant residues and agro-food industry waste
• Human hair and clean refractory brick
• Processed non-halogenated plastics (PE, PP, PET, etc.)

The annex excludes materials such as fluorinated plastics, e-waste, and any contaminated materials or waste treated with hazardous chemicals. It also provides flexibility for updating the list based on new scientific evidence or regulations.

Compliance and Oversight

The Subsecretary of Environment has been tasked with overseeing the compliance process. Should discrepancies arise—such as a mismatch between declared and actual materials—the goods must be returned to their country of origin within 30 days at the importer's expense. In case of repeated violations, businesses may face bans on applying for new permits for up to one year.

The TAD platform and VUCEA system ensure that all trade movements are tracked electronically, improving the efficiency of processing and reducing administrative delays. The new regulations aim to streamline operations while ensuring that waste management practices meet both Argentina's environmental standards and international obligations.

The resolution also enhances international collaboration in the management of cross-border waste. Argentina has committed to upholding its responsibilities under the Basel Convention and other international agreements, ensuring that non-hazardous waste is handled according to environmentally sound practices.

The government has stated that the new rules will foster Argentina’s circular economy, enabling the country to better manage recovered materials while minimizing environmental impact. For further details, you can consult the Resolution 393 (in Spanish) here.

Argentina’s national medicines and food regulator (ANMAT) has announced sweeping changes to its import procedures, lifting pre-authorization requirements for a range of consumer health products in ...

Argentina’s national medicines and food regulator (ANMAT) has announced sweeping changes to its import procedures, lifting pre-authorization requirements for a range of consumer health products in a bid to modernize bureaucracy and streamline trade.

Under a new resolution published this week, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) will no longer require import approval for cosmetics, household disinfectants, dental hygiene items, and disposable hygiene products. The move, part of Disposición 4033/2025,  also applies to samples for trade exhibitions, laboratory testing, donated goods, and raw materials used in the production of these items.

Officials say the change is intended to simplify administrative processes and reduce delays at borders.

Still Regulated, But With Less Paperwork

While companies no longer need prior ANMAT intervention for importing these products, they must continue to comply with existing health and safety rules. Importers are now required to submit a sworn notice (“Aviso de importación”) via the government’s online platform within 48 hours after goods are cleared through customs.

The new policy comes into effect on the 9th of July 2025, giving businesses time to adjust.

Industry groups such as the Cámara Argentina de la Industria de Productos de Higiene Personal, Cosmética y Perfumería (CAPA) and the Asociación Argentina de Químicos Cosméticos (AAQC) have welcomed the measure, citing improved trade fluidity and reduced red tape. This regulatory shift is seen as part of Argentina’s broader efforts to modernize its public health administration and facilitate international commerce amid growing consumer demand and technological advancement in the hygiene and cosmetic sectors. For further details, you can find the Disposition here (in Spanish). 

In a move welcomed by the healthcare and medical technology sectors, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued a new Disposition that reduces the m...

In a move welcomed by the healthcare and medical technology sectors, Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) has issued a new Disposition that reduces the minimum shelf life required for imported medical devices from one year to six months, effective immediately.

The change was made official through the Disposition 2565/2025 issued on April 15, 2025, which replaces Disposición N° 1655/1999, a long-standing rule that prohibited the import of medical devices with less than 12 months before expiration. The updated regulation aims to align ANMAT’s oversight with technological advances in medical devices, and to ease restrictions that stakeholders argued were limiting access to innovative products.

According to ANMAT, the review process was initiated following requests from industry representatives involved in the manufacturing, importation, and distribution of medical devices. These groups expressed concern that the original one-year requirement restricted imports and delayed the arrival of critical healthcare technologies.

Under the new framework:

• Medical devices and their accessories must now have at least six (6) months of shelf life remaining at the time of importation.

• Devices with a total approved shelf life of six months or less are exempted, provided they are not expired upon entry.

• Single-use sterile products—whether imported or locally manufactured—may not be re-sterilized, reused, or have their original packaging altered, unless specifically authorized by regulatory resolution.

• Falsifying expiration dates on packaging is explicitly prohibited and may lead to sanctions under Law No. 16.463 and possible criminal charges.

The revised policy reflects ANMAT’s intention to improve regulatory efficiency without compromising safety. The agency emphasized that shorter shelf lives should not translate into lower standards, and all products must still comply with the established quality and safety benchmarks. This update is expected to enhance the flexibility of Argentina’s healthcare supply chain, enabling hospitals and clinics to access a wider range of medical technologies while maintaining oversight to ensure patient safety. For further details, you can consult the Disposition (in Spanish) here.

The Argentine Ministry of Health has issued Resolution 915/2025, updating existing regulations on lead content in paints, lacquers, and varnishes. The new resolution introduces significant changes aim...

The Argentine Ministry of Health has issued Resolution 915/2025, updating existing regulations on lead content in paints, lacquers, and varnishes. The new resolution introduces significant changes aimed at streamlining import procedures while maintaining strict health and safety standards.

The original regulation, established in Resolution 7/2009, prohibited the manufacture, import, commercialization, and free distribution of paints containing more than 0.06% lead by mass in non-volatile content. The latest update replaces and clarifies certain provisions to enhance compliance measures and improve trade facilitation.

Key Updates in Resolution 915/2025

1. Pre-Import Declaration Requirement:

   • Importers must now submit a sworn declaration confirming that their products comply with the lead limit before import clearance.

   • This declaration will be sufficient for customs clearance, provided all other import requirements are met.

2. Post-Market Compliance Checks:

   • The Instituto Nacional de Tecnología Industrial (INTI) will be responsible for verifying compliance after importation through market inspections and factory audits.

   • If an infraction is detected, the violator will bear the cost of laboratory testing.

3. Scope of Prohibition Defined:

   • The restrictions continue to apply to paints used in homes, healthcare facilities, schools, furniture, children’s toys, and playground equipment.

   • Exemptions have been granted to industrial-use paints, including those for automobiles, aircraft, bridges, agricultural equipment, and traffic markings, which will no longer require the sworn declaration.

4. Labeling Requirements for Lead-Containing Paints:

   • Products that exceed the permitted lead levels must display a mandatory health warning:
     ADVERTENCIA: Este producto contiene plomo. Su ingestión provoca daño a la salud. Producto de uso exclusivo para...” (WARNING: This product contains lead. Ingestion may cause health damage. Product for exclusive use in...)

   • The label must specify the approved applications for the product.

5. Enhanced Customs Control:

   • The Dirección General de Aduanas (DGA), under the Agencia de Recaudación y Control Aduanero (ARCA), will implement selective import control mechanisms in line with risk assessment protocols.

Impact on the Industry

The resolution is expected to simplify import procedures and remove bureaucratic barriers while ensuring that health risks remain controlled. The regulation also brings clarity to businesses by explicitly defining which products fall under the restriction and ensuring that industrial-use paints are excluded from unnecessary compliance burdens.

Next Steps

Resolution 915/2025 has been formally communicated to the relevant regulatory agencies, including the Customs Authority (DGA) and INTI, which will oversee implementation. The changes take immediate effect following their official publication in Argentina’s Boletín Oficial.

For further details, stakeholders are encouraged to review the full resolution text as published by the Ministry of Health, here (in Spanish).