Approval of the Pharmacovigilance Officer for Pharmaceutical Establishments

about-the-service

This service allows Marketing Authorization Holders to submit an application to approve and register their QPPV (Qualified Person Of Pharmacovigilance) officers.

service-process

when-applying-through-the-website

• Log in using UAE PASS to start the service.
• Fill out the application form.
• Attach the required documents.
• Submit the application.
• Approval of the Pharmacovigilance Officer for Pharmaceutical Establishments.

conditions-and-requirements

• QPPV must be resident in the UAE, and a doctor or pharmacist.
• QPPV must have experience in pharmacovigilance, monitoring of side effects and risk analysis.
• QPPV must hold an appropriate qualification in pharmacovigilance from an international establishment.

required-documents

• Letter of appointment from the medical facility.
• QPPV Qualification Certificate from university or postgraduate education.
• Statement of QPPV experience.
• CV of the QPPV.
• Applicant's training certificates.
• Applicant's proof of UAE residency.
• List of products covered by QPPV.
• Minimum of 15 ADR reports in the UAE.
• SOP of the QPPV in the company.

faqs

• Can I apply for this service manually?
• This service is exclusively an e-service. submission via email or manually will not be obtained.