Science & Technology in Action

Health Products Regulatory Authority

The mission of the Health Products Regulatory Authority (HPRA), previously known as the Irish Medicines Board, is ‘to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products’. The IMB assesses and regulates the safety, quality and efficacy of medicines and medical devices available in Ireland.

Members of staff of the IMB together with the assistance of the Board’s committees and individual experts review the scientific aspects relating to the safety and efficacy of medicines and medical devices used in Ireland. Once a medicine or a medical device is made available for use, the IMB monitors the type and frequency of any reported side-effects. Companies placing medicines or medical devices on the Irish market are required to keep the IMB informed of events with potential safety consequences for their products.

The Health Products Regulatory Authority also monitors the quality of medicines by conducting inspections at sites of manufacture and distribution of medicines and by random sampling of products both pre and post authorisation. The HPRA also audits and monitors the ongoing performance of Notified Bodies for medical devices, who are responsible for assessing devices before they are placed on the market. The use of medicines and medical devices for clinical research purposes also falls within the HPRA’s remit. In the case of veterinary medicines there must likewise be assurance of quality, safety and efficacy but in addition the consequences to human health of the use of medicines in animals must be considered.

In addition to its regulatory activities the Health Products Regulatory Authority also carries out enforcement of many of the regulations for which it has responsibility. Enforcement activities include investigation of potential breaches of regulations and a range of measures, including prosecution, may be applied.

You can find out more about the work of the Health Products Regulatory Authority (HPRA) on www.hpra.ie