MedNova Lifesciences

Interactive NAFDAC QPPV & PV Compliance Readiness Assessment

Under NAFDAC's pharmacovigilance guidelines (reinforced by Nigeria's WHO ML3 status), Marketing Authorization Holders (MAHs) must maintain strict, continuous, and in-country safety monitoring. Take this quick 2-minute assessment to identify gaps in your Nigerian PV compliance.

Your details

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1. Do you have a permanently resident, qualified QPPV physically located in Nigeria?

YesNoIn Progress

2. Do you have a formally designated deputy/backup QPPV in Nigeria to ensure continuous coverage?

YesNoIn Progress

3. Is there a named Local Safety Officer (LSO) or Local Contact Person for PV registered with NAFDAC?

YesNoIn Progress

4. Is your Pharmacovigilance System Master File (PSMF) fully localized and regularly updated for Nigerian operations?

YesNoIn Progress

5. Do you have an active, validated pathway for capturing and processing local Adverse Drug Reactions (ADRs)?

YesNoIn Progress

6. Do you conduct weekly literature monitoring across local Nigerian medical journals and news sources?

YesNoIn Progress

7. Are you actively tracking and submitting PSURs/PBRERs in alignment with NAFDAC regulatory cycles?

YesNoIn Progress

8. Have you submitted product-specific Risk Management Plans (RMP) or educational materials to NAFDAC?

YesNoIn Progress

9. Do you have a formalized process for safety signal detection and escalation of safety concerns in Nigeria?

YesNoIn Progress

10. Are your local PV SOPs and training records audit-ready for a surprise NAFDAC inspection?

YesNoIn Progress