Medicinal Product 
End-to-end support from experienced Regulatory experts.

Medicinal Products Regulatory Support in Argentina – Overview 

As one of the leading pharmaceutical markets in Latin America, Argentina offers significant opportunities for pharmaceutical manufacturers seeking market entry, regional supply, or local partnerships. The national Regulatory authority, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), oversees medicines, biologicals, medical devices and related products. Successful market entry requires a clear Regulatory strategy, accurate dossier preparation in Spanish, a local registration/marketing authorization holder (MAH) and compliance with ANMAT requirements. Freyr provides Regulatory support to streamline Argentina drug registrations and reduce time to market.

Medicinal Product Classification in Argentina 

ANMAT classifies medicinal products into categories generally comparable to international practice:

• Chemical drugs (small molecule medicines; originator and generics)
• Biological medicinal products (therapeutic biologics, vaccines)
• Advanced therapy products / biotech-derived medicines
• Over-the-counter (OTC) vs prescription medicines
• Veterinary medicines (separate Regulatory pathway)
• Medical devices and in-vitro diagnostics (IVDs) are regulated under specific frameworks

Regulatory pathway, dossier content and review expectations depend on the product category and whether the submission is a new chemical entity, generic, biologic or variation.

Medicinal Product Drug Registration & Approval

• Regulatory Authority: ANMAT (Ministry of Health, Argentina) performs dossier evaluation, inspections and market authorization approvals.
• Local Representative / MAH: Foreign applicants must appoint a legally established local registration holder/authorized representative in Argentina who will be responsible for submissions, pharmacovigilance, and Regulatory communication with ANMAT.
• Language: All submissions, labeling, SmPC (ficha técnica) and patient leaflet (prospecto) must be provided in Spanish.
• Dossier Format: CTD-format (Module 1–5) is commonly used for full submissions. Electronic submission requirements should be confirmed with ANMAT; Freyr supports eCTD/structured dossier publishing as required.
• Typical dossier components:
  
  • Administrative and legal documents (application form, MAH authorization, powers of attorney)
  • Product labeling, SmPC (ficha técnica) and patient leaflet in Spanish
  • Quality (CMC) information: drug substance & product, manufacturing process, specifications, stability data
  • GMP certificate for the manufacturing site(s) — GMP issued by the country of manufacture and/or ANMAT-recognized certificates; ANMAT may require inspections for certain products
  • Certificate of Pharmaceutical Product (CPP) and Free Sale Certificate (as applicable)
  • DMF or detailed manufacturing information when needed
  • Non-clinical and clinical data: full clinical study reports for new drugs; for generics, bioequivalence (BE) or biowaiver data per ANMAT guidance
  • Pharmacovigilance system information and local Qualified Person for Pharmacovigilance (QPPV) responsibilities
  • Risk management plans (RMP) where applicable
• Clinical trials: Conduct of clinical trials requires ANMAT authorization and approval by local Ethics Committees/Institutional Review Boards (IRBs). Good Clinical Practice (GCP) compliance is required.
• Review and approval: ANMAT conducts scientific and administrative review; depending on product and complexity, timeline can vary. Priority or accelerated pathways may apply in specific circumstances (e.g., public health priority medicines, orphan products).

Specifics for Key Product Types 

• Generics: Generally, require demonstration of pharmaceutical equivalence and bioequivalence studies (BE) per ANMAT requirements; dossier focused on comparative data and manufacturing controls.
• Biologics and Biosimilars: Require extensive characterization, comparability studies, clinical data and often facility inspections; Regulatory expectations are more rigorous and case-by-case.
• Vaccines & Complex Biologics: Additional quality and batch release requirements, detailed manufacturing controls and cold-chain considerations.

Post-Approval & Pharmacovigilance 

• Post-market obligations include expedited and periodic safety reporting (individual case safety reports / ICSRs), Periodic Safety Update Reports (PSUR/PBRE) as required, change management/variations, stability commitments and advertising/packaging compliance.
• Variations (post-approval changes) must be submitted to ANMAT according to the change type (minor/major) and handled per ANMAT timelines.
• Market surveillance, inspections, and product sampling by ANMAT are part of ongoing compliance.