Access to information from ADR reports

The HPRA operates the national system for recording and reporting details of suspected adverse reactions/events occurring in Ireland which are notified in association with the use of medicines. Information from these reports for a particular medicine, including details of the reason for use of the medicine, the name(s) and dose(s) of suspected medicine(s) concerned and the effects experienced are made available in a summary listing format, excluding personal information. These listings are the same as those released under Freedom of Information requests for data from adverse reaction reports. The listings are provided without a requirement for a Freedom of Information Act request and in a shorter timeframe, through submission of a request to medsafety@hpra.ie