Reporting a Product Defect

Suspected or obvious product defects may be reported to the Quality Defects Section of the Irish Medicines Board by post, e-mail, fax or telephone (in the case of defects which could be considered to be life threatening or harmful to patients).  

Reports can also be made via our on-line reporting system.

Pharmacists may use the IMB postage-paid 'green card' to report suspected quality defects, which is available upon request from the Market Compliance Section. For additional copies of the these forms please e-mail your request to recallsandqualitydefects@imb.ie.

PLEASE NOTE: When reporting a product defect to the IMB, please ensure that the following information is included:

• The exact name of the medicinal product
• The Product marketing Authorisation Number (PA/VPA/EU Number), if any
• The product dosage form (e.g. Tablets) and Strength (e.g. 75 mg)
• The Batch or Lot Number
• The Expiry Date
• The Name of the Marketing Authorisation Holder
• Where you obtained the product from (e.g. the wholesaler or pharmacy name, and their address)
• An exact and full description of the suspected defect (please be as specific and as detailed as possible)
• Your name, address and contact details, including telephone number(s)
• The date on which you are reporting the quality defect

Important Note in relation to suspected Adverse Events/Reactions
Information on reporting a suspected adverse event/reaction to a medicinal product is available on the Safety Related Problems page.

For Further Information please contact the following:

E-mail:    recallsandqualitydefects@imb.ie  

Post:
Compliance Department - Quality Defects
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Fax: +353 1 676 4061 (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