Quote from VigiServe Admin on February 10, 2026, 3:03 PM

In Cabo Verde (Cape Verde), pharmacovigilance is coordinated by the Entidade Reguladora Independente da Saúde (ERIS) through the Centro Nacional de Farmacovigilância (CNF). The system is WHO-aligned and centralized, focusing on spontaneous reporting rather than complex industry obligations.

1. Clinical Safety (Clinical Trials)

Clinical trials require ERIS/Ministry of Health approval and generally follow international standards (ICH).

• Expedited Reporting: Sponsors are expected to report SUSARs following standard international timelines:

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Submission: Reports go directly to ERIS via email or forms.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files.

• Personnel & Infrastructure:

  • No Local QPPV: Not required.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous (via ERIS website).

  • Timelines: "Prompt" reporting is expected for serious cases (generally interpreted as 15 days).

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory; may be requested on a case-by-case basis.

  • RMPs: Reactive; not a standard requirement.

Summary of Requirements

Component	Requirement in Cabo Verde
Regulatory Authority	ERIS (Entidade Reguladora Independente da Saúde)
Framework	ERIS Statutes / WHO
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days - International practice)
Submission Language	Portuguese