##  [ANVISA VigiMed Instruction Manual for Adverse Event Notification in Health Services](/mandate/anvisa-vigimed-instruction-manual-for-adverse-event-notification-in-health-services) 

June 9, 2026

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.



[Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/markdownify/node/13668)



Source

[https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/notificac…](https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/notificacoes/vigimed/arquivos/manual-de-instrucoes-de-notificacao-no-sistema-vigimed-para-servicos-de-saude-1.pdf)

[https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-lanca-manu…](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-lanca-manual-de-instrucoes-do-vigimed-para-profissionais-dos-servicos-de-saude)

 

 

Select Mandate HA

[ANVISA](/mandate-by-ha/anvisa)

 

Select Mandate Function

[Regulatory Affairs](/mandate-by-function/regulatory-affairs)