About Us
The mission of the Irish Medicines Board is
'to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products'
The objective of the Irish Medicines Board is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of medicines available in Ireland and to participate in systems designed to do that throughout the European Union. Before a medicinal product can be authorised for use, an application must be made to the Irish Medicines Board and this must contain all of the necessary data supporting its quality, safety and efficacy.
The IMB is also the Competent Authority for the implementation of EU and national legislation relating to Blood and Blood Components and also for Tissues & Cells.
Members of staff of the IMB together with the assistance of the Board's committees and individual experts review the scientific aspects of the application and reach a conclusion on the likely balance of any benefits versus risk of the product before arriving at a decision. Following approval and use of a medicine, the IMB monitors the type and frequency of any reported side-effects. It is vital that healthcare professionals report suspected adverse effects and quality defects, since this forms an important part of the Irish Medicines Board's role. In addition, there is a responsibility on the holders of product authorisations to keep the IMB informed of events with potential safety consequences for their products.
The Irish Medicines Board 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 use of medicines for clinical research purposes also falls within the IMB'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 Irish Medicines Board 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.