Get expert support with the assessment, planning and management of a medical product recall, pharmaceutical recall, or medicine quality defect.

This consultation is designed for pharmaceutical manufacturers, Marketing Authorisation Holders (MAHs), wholesalers, distributors and quality teams who need practical guidance when dealing with a potential or confirmed product recall.

Support can include:

• Assessment of whether an issue constitutes a product recall, stock recovery or market withdrawal
• Initial quality defect and patient risk assessment
• Determining the appropriate recall classification and recall level
• Support with HPRA product recall requirements and regulatory communication
• Development and review of a pharmaceutical recall strategy
• Distribution traceability and identification of affected customers
• Preparation and review of recall notification letters
• Guidance on wholesaler, pharmacy, retail or patient-level recalls
• Recall reconciliation and effectiveness checks
• Investigation support, root cause analysis (RCA) and CAPA
• Review of recall SOPs, procedures and mock recall systems
• Advice on GDP and GMP compliance relating to product recalls and quality defects

The consultation provides clear, practical advice from a pharmaceutical quality and Qualified Person (QP) perspective, helping you understand the regulatory expectations, assess the risk and determine the appropriate next steps.

Suitable for organisations operating within the Irish and EU pharmaceutical market, including companies requiring support with HPRA recalls, EU GMP, GDP, medicinal product quality defects, batch recalls, market withdrawals and pharmaceutical regulatory compliance.