The Irish Medicines Board operates a Medicinal Product Defect Reporting and Investigation Programme.
Product defects, also known as Quality Defects, may be defined as attributes of a medicinal product or component which may affect the quality, safety and/or efficacy of the product, and/or which are not in line with the approved Product Authorisation (PA) or Veterinary Product Authorisation (VPA) file, or other marketing authorisation.
There are three classes (or ratings) of quality defects and these are classified according to their potential threat to patient well-being and public health in general.
Critical Quality Defects - defects which are potentially life-threatening or could cause a serious risk to health
Major Quality Defects - defects which could cause illness or mistreatment but are not critical
Minor Quality Defects - defects which may not pose a significant hazard to health
The Irish Medicines Board also receives notifications of product defects from the medical professions, patients and consumers, distributors and wholesalers, and from other Competent Authorities.
Medicinal product manufacturers are legally obliged to report to their Competent Authority (for Irish-registered products and/or products manufactured in Ireland, this is the IMB) any defect in a medicinal product that could result in a product recall or abnormal restriction of supply. It is usually the Qualified Person (QP) responsible for batch release of the product in question who is expected to report the quality defect to the IMB.
All Quality Defects are investigated on a case-by-case basis. Quality defects may result in Product Recalls, in the issuance of a Caution-in-Use notification to pharmacists and to the medical professions, or in other actions requested of a company by the IMB. Other Competent Authorities may be informed by the IMB of the quality defect issue.
A significant part of the quality defect programme concerns actions to ensure that a programme of timely corrective actions is put in place in order to prevent a recurrence of the defect.
For further information please contact the following:
Email:
recallsandqualitydefects@imb.ie
Post:
Compliance Department – Quality Defects
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland
Fax:
+353-1-6764061 (Note: Fax machine is manned during office hours only)
Telephone:
Mr. Kevin O’Donnell, Market Compliance Manager
Office contact no.: +353-1-676 4971
Out-of-hours contact no.: +353-87-9562818 (mobile)
Ms. Breda Gleeson, Market Compliance Inspector
Office contact no.: +353-1-676 4971
Out-of-hours contact no.: +353-87-9703559 (mobile)
Mr. John Lynch, Director of Compliance
Office contact no.: +353-1-676 4971
Out-of-hours contact no.: +353-87-2347294 (mobile)
Ms. Aoife Farrell, Quality Defects and Recall Manager
Office contact no.:+353-1-676 4971
Out-of-hours contact no.: +353-86-0249808 (mobile)
Mr. Rob Smyth, Market Compliance Technical Officer
Office contact no.: +353-1-676 4971