Approval of the Pharmacovigilance Officer for Pharmaceutical Establishments

Service Description

This service allows Marketing Authorization Holder companies to submit an application to approve and register their Qualified Person Responsible for Pharmacovigilance (QPPV), in fulfilment of Emirates Drug Establishment (EDE) requirements.

Service Process

• 1. Log in using UAE PASS to start the service
• 2. Fill out the application form
• 3. Attach the required documents
• 4. Pay the fees
• 5. Submit the application
• 6. Approval of the Pharmacovigilance Officer for Pharmaceutical Facilities

Conditions & Requirements

• • The QPPV must be a licensed doctor or pharmacist residing in the UAE
• • The QPPV must hold a recognised pharmacovigilance training certificate from an internationally accredited institution
• • The QPPV appointment letter must be issued directly by the Marketing Authorization Holder company, not by the local medical warehouse

Required Documents

• • Appointment letter for the QPPV issued by the Marketing Authorization Holder company
• • QPPV university or postgraduate qualification certificate
• • QPPV experience certificates
• • QPPV curriculum vitae (CV)
• • Pharmacovigilance training certificates
• • Copy of UAE residency
• • List of products to be covered by the QPPV
• • Minimum of 15 adverse drug reaction (ADR) reports submitted in the UAE
• • Standard Operating Procedures (SOPs) for the QPPV's responsibilities within the company

FAQ’s

• Q: Can I apply for this service manually?
• A: This service is exclusively an e-service. Submissions via email or manually will not be accepted.