Human Medicines

Products for which medicinal claims are made or which contain substances likely to have effects on the body are considered as medicines, and will therefore need a marketing authorisation from the Irish Medicines Board (IMB). The marketing authorisation is issued with a Product Authorisation (PA) number which is included on the container.

In order to obtain a marketing authorisation, a company must submit information to the IMB which examines the data to make sure that the medicinal product meets standards of quality, safety and efficacy. In determining the safety, quality and efficacy the IMB draws upon the expertise of its staff and its Advisory Committee for Human Medicines (appointed by the Minister for Health). Expert advisory panels also meet as required. The mandate of the Advisory Committee is to assist and advise the Board and the staff in relation to any matters concerning public health or the safety, quality or efficacy of medicinal products for human use which may be referred to it.

The Irish Medicines Board is also very active in European regulatory activities and procedures for assessment of medicinal products through the mutual recognition procedure, decentralised procedure and centralised procedures.

Individuals or companies requiring further information on the procedures for licensing human medicinal products in Ireland should review the relevant documents detailed in the Human Medicines Licensing section and/or contact the Irish Medicines Board for details at customerservice@imb.ie

Mailing Address:

Customer Service & Scheduling Unit,
Human Products Authorisation and Registration Department,
Irish Medicines Board
Kevin O'Malley House,
Earlsfort Centre,
Dublin 2,
Ireland.

Phone : +353-1-6764971
Fax: +353-1-6767836

The Irish Medicines Board - www.imb.ie

Human Medicines