ANVISA published MANUAL-F-ANVISA-034 on 09-Jun-2026 (original document date: 12-May-2026), providing official instructions, requirements, and best practices for the notification, documentation, and management of adverse medication events within the VigiMed system, supporting consistent pharmacovigilance activities by healthcare professionals in Brazil.
Policy Focus:
- Updated procedural guidance for healthcare services on adverse drug event reporting in the VigiMed system.
Scope:
- Applicable to healthcare professionals registered for institutional access to VigiMed, covering medicinal products and vaccines.
Key Requirements / Provisions:
- Scope & Applicability: Defines target users as healthcare professionals with institutional VigiMed access; specifies reportable products and adverse events.
- Notification Procedures: Step-by-step system access, profile setup, and form completion; five mandatory data elements: type, patient, adverse event, medication, and drug-event relationship.
- Data Entry Tools: Use of MedDRA and WHODrug dictionaries for consistent coding; structured guidance for narratives, patient info, medication details, and test results.
- Causality Assessment: WHO-UMC, Naranjo, and French algorithms; procedures for follow-up updates and statistical outputs.
- System Features: Statistical report generation, notification status tracking, glossary, and technical support channels.
Regulatory Goals:
- Strengthen healthcare professional participation in pharmacovigilance.
- Improve detection and management of safety signals.
- Reduce adverse drug event incidence in Brazil.
Source
Select Mandate HA
Select Mandate Function