Argentina is one of the largest pharmaceutical markets in Latin America, with strong demand for innovative medicines, medical devices, and health products.
The National Administration of Drugs, Food and Medical Technology (ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is the primary regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, cosmetics, and biologics in Argentina. ANMAT requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and often a local representative or sanitary registration holder. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate ANMAT requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this key Latin American market.
Get Argentina Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for ANMAT submissions.
End-to-end support for ANMAT registration of medicines, medical devices, biologics, and health products in Argentina.
Assistance with ANMAT import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on ANMAT GMP requirements, quality assurance documentation, certificate support, and preparation for inspections.
Setup of pharmacovigilance systems, adverse event reporting to ANMAT, periodic safety reporting, and risk management in Argentina.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with ANMAT post-registration requirements.
Spanish labelling review, ANMAT-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local sanitary registration holder/agent requirements, ANMAT liaison, regulatory follow-up, and ongoing compliance management in Argentina.
Strategic market entry planning, ANMAT pathway guidance, regulatory intelligence on Argentina’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Argentina — from ANMAT product registration and import permits to pharmacovigilance, Spanish labelling, and sustained Latin American market access.
Contact Our Argentina Regulatory Experts