Classification of Medicines

The HPRA provides a service to stakeholders to assist in clarifying which products should be categorised as medicinal products, medical devices or another regulated product and thereby fall under the remit of HPRA from a regulatory perspective and to distinguish such products from other products which are outside the scope of HPRA’s remit.

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

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 our Guide to Definition of a Human Medicine.

This guide should be used in conjunction with our Request for Classification of a Human Health Product.

Our Classification Committee (for human medicines) consists of HPRA staff with the appropriate scientific and regulatory expertise and experience and is chaired by the Director of Quality, Scientific Affairs and Communications.

Queries regarding changes in the prescription classification of authorised medicinal products (‘switch’ applications) should be directed to Further information is provided here.

Contact Us:

Classification Queries

T: +353 (0) 1 676 4971