Reporting Suspected Product Problems
This section provides information on mechanisms available to report suspected issues with medicinal products and medical devices to the Irish Medicines Board.
An adverse reaction is defined as a 'reaction to a medicinal products which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function'.
Further details can be found in the Drug Safety section.
A quality defect in a medicinal product may be defined as: an attribute of a medicinal product or component which may affect the quality, safety and/or efficacy of the product, and/or which is not in line with the approved Product Authorisation (PA) or Veterinary Product Authorisation (VPA) file, or other marketing authorisation.
Safety or Quality problems can be reported through our on-line system or by downloading the forms and using our freepost service.
If you are a patient or carer we recommend that you contact your doctor to discuss any reaction you may have experienced or any concern you may have in respect of the medication in question.