Quote from VigiServe Admin on February 6, 2026, 1:46 PM

In Mozambique, Pharmacovigilance is regulated by the National Directorate of Pharmacy (DNF) under the Ministry of Health (MISAU). The system relies on Decree 47/2016 and Ministerial Diploma 89/2017, functioning as a basic, WHO-aligned framework with a focus on public health programs (HIV, TB, malaria).

1. Clinical Safety (Clinical Trials)

Clinical trials require approval from MISAU/DNF and adherence to international/SADC norms.

• Expedited Reporting (SUSARs): Sponsors must report Suspected Unexpected Serious Adverse Reactions. While timelines are not rigidly codified in national law, practice aligns with ICH E2A:

  • Fatal or Life-Threatening: Within 7 days.

  • Other Serious Unexpected: Within 15 days.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates (ICH E2F format) may be required, particularly for multi-country trials.

• Submission: Direct to MISAU/DNF via forms or email; no national electronic portal exists.

2. Post-Marketing Pharmacovigilance

Post-approval requirements are minimal for Marketing Authorization Holders (MAHs), focusing on national coordination rather than industry bureaucracy.

• Personnel & Infrastructure:

  • Local QPPV: Not required.

  • PSMF: Not required.

• Incident Reporting (ICSRs):

  • Reporting is driven by healthcare professionals and hospitals, though MAHs are expected to report serious cases.

  • Timelines: Not rigidly fixed. "Prompt" reporting is encouraged for serious/unexpected events (regional SADC practice aligns with 15 days).

• Risk & Periodic Reporting:

  • PSURs/PBRERs: Not routinely required. Safety updates may be requested during registration renewal.

  • Risk Management Plans (RMPs): Not required as a standard; risk assessment is reactive.

Summary of Requirements