Pharmacovigilance is not a post-approval formality. It is a legal obligation and a direct patient safety function. In the GCC, authorities expect MAHs to run a functioning, documented system locally.
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Core obligations
Local QPPV: a qualified person responsible for pharmacovigilance, approved where required. In the UAE, MAHs apply to EDE to approve and register their QPPV.
Documented system: UAE Good Vigilance Practice guidance requires registered and marketed MAHs to document their pharmacovigilance system and its quality system, including a Pharmacovigilance System Master File (PSMF).
Case management: collection, assessment and timely reporting of Individual Case Safety Reports (ICSRs).
Periodic reporting: submission of periodic safety reports as required.
Risk management: local implementation of risk management plans and additional risk-minimisation measures.
Signal management: ongoing detection and evaluation of safety signals.
Where companies struggle
Global systems not adapted to local reporting timelines and formats.
Unclear responsibilities between the MAH, distributor and local agent.
Missing local literature screening and Arabic-language source review.
Weak documentation that fails during inspections.
How HERMS supports
HERMS provides local QPPV services, PSMF preparation, ICSR processing, periodic reporting, and inspection readiness for companies operating in the GCC.
Is your local pharmacovigilance system inspection-ready? Ask HERMS for a gap assessment. Contact HERMS →
References
UAE GVP Guidelines for MAHs: https://mohap.gov.ae/documents/20117/1212145/UAE+MOHAP+GVP+Guidelines+ver+13.pdf/cb3ee9cf-d4ca-c4d1-0a16-d4c6767000b2?t=1739146268067
EDE – Good Pharmacovigilance Practices guideline update: https://www.ede.gov.ae/en/w/ede-customer-council-discusses-implementation-of-good-pharmacovigilance-practices-guideline
EDE – Approval of the Pharmacovigilance Officer: https://www.ede.gov.ae/nl/w/approval-of-pharmacovigilance-officer-within-uae
Related: drug registration in the UAE: regulatory roadmap for manufacturers.
HERMS supports registration dossier preparation and pharmacovigilance activities for pharmaceutical and healthcare companies. Our services help businesses prepare regulatory documentation and address product safety requirements.
For further reading, explore HERMS’s overview of adverse-event reporting and ICSR processing. For official reporting, use the applicable authority channel, such as EDE’s reporting service for pharmaceutical facilities or the Saudi Vigilance System.