Defects

Medicinal Product Defect Reporting and Investigation Programme

The HPRA Quality Defects and Recall (QDR) group is responsible for receipt and investigation of quality defect issues. The QDR group handles defect issues for medicines for human and veterinary use, on the Irish market and also for medicines manufactured in Ireland for other markets. 

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. 

Classes of Quality Defects

There are three classes (or ratings) of quality defects and these are classified according to their potential risk to patient and/or animal health.

Critical Quality Defects

These are defects which are potentially life-threatening or could cause a serious risk to health

Major Quality Defects

These are defects which could cause illness or mistreatment but are not critical

Minor Quality Defects

These are defects which may not pose a significant hazard to health

We investigate all quality defects on a case-by-case basis. Quality defects can result in batch or product recalls, in the issuance of communications to healthcare professionals or in other actions requested of a company by the HPRA. We may also inform the relevant authorities in other countries of the quality defect issue. Further details on such market actions can be found on our recalls page.

A significant part of the quality defect programme concerns actions to ensure that a plan of timely corrective actions is put in place at the manufacturing site in order to prevent a recurrence of the defect. 

For further information or to report a suspected quality defect, the following resources are available:

To report a suspected quality defect, you can use our online reporting system.

Email: [email protected]

Post:
Compliance Department – Quality Defects
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland

Pharmacists may use the HPRA postage-paid ‘green card’ to report suspected quality defects, which is available upon request from the Market Compliance Section.

Fax: +353-1-6764061 (Note: Fax machine is manned during office hours only)

Telephone: (01) 6764971