Classification of Medicines

The Irish Medicines Board provides a service to stakeholders to assist in clarifying which products should be categorised as medicinal products and medical devices and thereby fall under the remit of IMB from a regulatory perspective and to distinguish such products from other products which are outside the scope of IMB’s remit.

A classification service is operated for products which are on the borderline of human medicines and other products such as food supplements, cosmetics and medical devices.

Requests for classification whether external or internal are ultimately presented to an internal multi-disciplinary Classification Committee which meets once a month. The outcome of the decision is conveyed promptly to the enquirers and in turn is accompanied by a recommendation for any action arising depending upon the circumstances.

In the event of an appeal to the Classification Committee decision, the matter will normally be referred to the Advisory Committee on Human Medicines for arbitration. Full details of the procedure can be found in the IMB Guide to the Definition of a Human Medicine. This guide and the Request for Classification Application Form can be found in the publications section of the website.

The IMB Classification Committee (human medicines) consists of IMB staff with the appropriate scientific expertise and experience from the Human Products Authorisation and Registration, Compliance and Human Products Safety Monitoring Departments and is chaired by Dr. J.M. Morris, Director of Scientific Affairs.

The Irish Medicines Board - www.imb.ie

Classification of Medicines