Monitoring medicine safety, also known as pharmacovigilance, includes all activities relating to the detection, assessment, understanding and prevention of adverse effects or other possible drug-related problems.

In Ireland, the IMB is responsible for monitoring medicine safety, including operation of the national adverse reaction reporting system.

Health care professionals (including doctors, dentists, pharmacists and nurses) are requested to report  suspected adverse reactions observed in their practice. Of particular importance are all suspected reactions to newly authorised products, serious reactions to established products and suspected reactions to vaccines or medicines used in pregnancy. Further information on reporting of adverse reactions by health care professionals can be found on the Health Care Professional & Consumers page.

The IMB encourages patients/consumers to report suspected adverse reactions which they think may be associated with their medication. However, if you are a patient/consumer or carer the IMB recommends that you contact your doctor to discuss any reaction you may have experienced or any concern you may have in respect of any medicine to ensure appropriate management i.e. changes to your existing treatment or therapy for the management of an adverse reaction. Further information on reporting of adverse reactions can be found on the Health Care Professional & Consumers page.

Pharmaceutical companies and Clinical Trial sponsors are obliged by law to submit adverse reaction reports and cumulative safety data associated with use of their products. Further information on reporting requirements for companies/clinical trial sponsors can be found on the Companies page.