Pharmacovigilance Services in Ireland

DDReg provides pharmacovigilance services in Ireland for pharmaceutical marketing authorisation holders. Our team manages HPRA pharmacovigilance obligations for nationally and centrally authorised products, coordinates EudraVigilance reporting, prepares PSURs, and delivers pharmacovigilance outsourcing Ireland mandates across the full post-marketing lifecycle.

• + PV System Operation and Adverse Event Reporting
  • PSMF Maintenance: Pharmacovigilance System Master File maintained as a living document. Article 57 database updated immediately upon QPPV or PSMF location changes; no variation submission required since February 2016. PSMF must be available to HPRA within 7 days upon request.
  • ICSR Processing: Includes case triage, MedDRA coding, causality assessment, narrative writing, and electronic submission to EudraVigilance. Serious unexpected SADRs reported within 15 days and non-serious ICSRs within 90 days.
  • HPRA Spontaneous Report Coordination: Coordination of healthcare professional and consumer reports received by HPRA, including MAH follow-up where reporter is identified and integration with the national adverse reactions database.
  • Biologics Batch Traceability: Recording of batch numbers for suspected adverse reactions related to biological medicinal products prescribed, dispensed, or sold in Ireland in line with Irish regulatory requirements.
• + Drug Safety Services Ireland – PSURs and Signal Management
  • PSUR Repository Submission: All PSURs uploaded to the EMA PSUR Repository with HPRA notified via repository procedures. Monitoring of EURD list for data lock point changes and submission frequency per EURD list or registration requirements.
  • Signal Management: Monitoring PRAC signal outputs, implementation of HPRA safety measures, and updates to benefit-risk evaluations.
  • RMP Support: Risk Management Plan preparation and maintenance; HPRA submission coordination; risk minimisation effectiveness tracking
  • DHPC Coordination: Preparation of Direct Healthcare Professional Communications and submission to HPRA in accordance with SUR-G0030 guidance, including Vigilance Assessment section distribution list inclusion and engagement with professional societies and patient organisations.
• + HPRA Inspection Readiness and Compliance
  • HPRA Inspection Preparation: Support for routine and triggered pharmacovigilance inspections, including maintenance of audit-ready PSMF and case files and coordination of mock inspections.
  • GVP Compliance: Alignment with EU GVP modules and implementation of Irish regulatory requirements under S.I. No. 272 of 2012.
  • Post-Authorization Studies: Preparation of PASS protocols, HPRA notification, and submission of study reports.