What is the difference between RAM, IPAS, PGR, and RFV in Argentina?

Argentina uses Spanish-language pharmacovigilance terminology distinct from ICH nomenclature. RAM (Reacción Adversa a Medicamento) is the Argentine term for adverse drug reaction. IPAS (Informes Periódicos de Actualización de Seguridad) are periodic safety update reports equivalent to PSURs. PGR (Plan de Gestión de Riesgos) is the Argentine risk management plan equivalent to RMP. RFV (Responsable de Farmacovigilancia) is the designated pharmacovigilance responsible person equivalent to the EU QPPV. All ANMAT pharmacovigilance submissions use this Spanish terminology.

How does the SNFVG decentralized pharmacovigilance system work in Argentina?

The Sistema Nacional de Farmacovigilancia (SNFVG) is Argentina’s decentralized national pharmacovigilance system with regional centres distributed across provinces. Healthcare professionals, pharmacists, and consumers can report RAM events to their local regional centre. ANMAT in Buenos Aires coordinates the national system and receives Marketing Authorisation Holder safety reports centrally through the TAD digital platform.

Must all ANMAT pharmacovigilance submissions be in Spanish?

Yes. ANMAT requires all regulatory submissions, including pharmacovigilance documentation, to be submitted in Spanish. RAM adverse event reports, IPAS periodic safety updates, PGR risk management plans, safety correspondence, and clinical trial safety reports are submitted in Spanish through the ANMAT TAD online platform.

What are the pharmacovigilance reporting timelines in Argentina?

In Argentina, serious adverse drug reactions are typically reported within 7 to 15 calendar days depending on severity and regulatory classification. Non-serious adverse events are usually submitted through periodic safety reports according to ANMAT pharmacovigilance guidance.

Pharmacovigilance Services in Argentina

Your Local Pharmacovigilance Partner for Drug Safety in Argentina

DDReg provides pharmacovigilance services in Argentina for pharmaceutical marketing authorisation holders (MAHs). Our team manages ANMAT pharmacovigilance obligations through the SNFVG national system, operates local PV functions including RFV (Responsable de Farmacovigilancia) coordination, submits RAM (Reacción Adversa a Medicamento) adverse event reports, prepares IPAS periodic safety updates, and delivers pharmacovigilance outsourcing Argentina mandates across the full post-marketing lifecycle

Argentina Pharmacovigilance Framework

The National Administration of Drugs, Food and Medical Technology (ANMAT; Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is Argentina's regulatory authority for pharmacovigilance. Headquartered in Buenos Aires, ANMAT operates the Sistema Nacional de Farmacovigilancia (SNFVG), a decentralized national system with regional centres across Argentina. The primary legislation is Law No. 16,463 (1964) on medication import/export, supplemented by ANMAT Disposition No. 1680/2011 and ANMAT Disposition No. 6677/10 on clinical trial safety reporting.

Argentina uses Spanish-language PV terminology distinct from ICH nomenclature. RAM (Reacción Adversa a Medicamento) is the Argentine ADR equivalent. RFV (Responsable de Farmacovigilancia) is the QPPV role. IPAS (Informes Periódicos de Actualización de Seguridad) are PSURs. PGR (Plan de Gestión de Riesgos) is the Argentine RMP. All ANMAT submissions are conducted in Spanish through the TAD online platform. Foreign MAHs require local representation, the MAH must be an Argentine legal entity or appoint an Argentine authorised representative.

Pharmacovigilance Outsourcing Argentina - DDReg Services

+ Local PV Function and RFV Coordination
- Argentina RFV (Responsable de Farmacovigilancia): Designated PV responsible person for ANMAT-registered products; coordinates SNFVG reporting; manages ANMAT TAD platform submissions; receives ANMAT queries
- SNFVG System Operation: Integration with the decentralized SNFVG national network; regional centre coordination; Spanish-language ICSRs case processing
- RAM Processing (Argentine ADR Reports): Individual case triage, Spanish-language narrative writing, causality assessment; RAM submission to ANMAT via TAD platform; 7-day serious adverse event reporting
- Literature Surveillance: Systematic medical literature review including Latin American Spanish-language journals; reportable cases processed per ANMAT timelines
+ Drug Safety Services Argentina - IPAS and PGR
- IPAS Preparation (Argentine PSUR): Informes Periódicos de Actualización de Seguridad prepared in Spanish; ANMAT submission via TAD platform; frequency per ANMAT registration requirements
- PGR Support (Argentine RMP): Plan de Gestión de Riesgos preparation and submission; risk minimisation measures designed for Argentine healthcare context; effectiveness assessment
- Signal Management: ANMAT safety communication monitoring; SNFVG signal output review; Spanish-language ANMAT query responses
- Post-Market Surveillance: ANMAT post-marketing surveillance obligations; recall coordination; product safety updates
+ Spanish-Language Capability and TAD Platform
- Spanish Regulatory Writing: All ANMAT PV submissions prepared in Spanish; RAM narrative authoring; IPAS report writing; PGR documentation; ANMAT correspondence management
- TAD Platform Management: ANMAT TAD (Trámites a Distancia) online platform submissions; electronic dossier upload status tracking; ANMAT query responses via TAD
- Argentine Legal Entity Coordination: Local MAH or authorised representative management; ANMAT registration number maintenance; regulatory liaison

Argentina Pharmacovigilance Reporting Timelines

Obligation	Deadline	Route
RAM - Serious Adverse Event (SAE)	Within 7 days of awareness	ANMAT TAD platform; Spanish-language submission
RAM - Clinical trial SUSAR	7 days (fatal/life-threatening); 15 days (non-fatal)	ANMAT per Disposition 6677/10
IPAS (Argentine PSUR)	Per ANMAT registration schedule	ANMAT TAD platform; Spanish language
PGR (Argentine RMP)	On ANMAT request	ANMAT TAD platform; Spanish language
Post-marketing RAM	Ongoing; serious events prioritised	ANMAT SNFVG; TAD platform

Pharmacovigilance Company in Argentina - DDReg Expertise

SNFVG Decentralized System Knowledge

Argentina operates a decentralized pharmacovigilance system, the SNFVG includes regional centres across provinces. DDReg coordinates RAM submissions into the SNFVG at both national and regional levels, manages relationships with ANMAT central authority in Buenos Aires, and ensures Spanish-language compliance across all reporting obligations.

Spanish Regulatory Writing and TAD Platform

All ANMAT pharmacovigilance submissions - RAM adverse event reports, IPAS periodic updates, PGR risk management plans , and safety correspondence are conducted in Spanish. DDReg provides Argentine Spanish regulatory medical writing for all PV documentation and manages electronic submission through the ANMAT TAD (Trámites a Distancia) platform, which is the exclusive submission channel for post-marketing PV obligations.

Argentine Terminology and Local Representation

Argentina uses distinct Spanish PV terminology: RAM for ADR, RFV for QPPV, IPAS for PSUR, PGR for RMP. ANMAT requires the MAH to be an Argentine legal entity or appoint an Argentine authorised representative. DDReg coordinates the local RFV function, manages the Argentine legal entity liaison, and ensures all ANMAT communications, including inspection coordination and post-marketing compliance — are handled by a Spanish-speaking team familiar with Argentine regulatory practice.

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