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'.  
Please see Drug Safety section for further details.
 
A quality defect is defined as an unplanned attribute of a medicinal product, an investigational medicinal product, or a component of such (e.g. the active pharmaceutical ingredient), which may affect the quality, safety and/or efficacy of the product, and which is not in line with the approved marketing authorisation/product registration file, if any, for that product or component;

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.