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The Irish Medicines Board -

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About Us

The mission of the Irish Medicines Board (IMB) is

'to protect and enhance public and animal health through the regulation of medicines, medical devices and healthcare products'

The objective of the IMB 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 medicine can be authorised for use, an application must be made to the IMB and this must contain all of the necessary data supporting its quality, safety and efficacy. 

The IMB is also the Competent Authority for the regulation of Medical Devices and Cosmetic products in Ireland. In addition, it is responsible for the implementation of EU and national legislation relating to Blood and Blood Components, Organ transplantation and also for Tissues & Cells.

Our stakeholders include patients, animal keepers and owners, healthcare professionals, sponsors of clinical trials and investigations, licence/authorisation holders, industry associations, environmental protection authorities, and our partners in other Irish and European regulatory agencies.

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 a medicine 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 IMB'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 IMB 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 IMB 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.

Date Printed: 18 April 2014

© Irish Medicines Board 2014 | Developed by Engine Solutions

Address: Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland.
Tel: 353-1-676 4971