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. Such products may or may not fall under the remit of HPRA from a regulatory perspective. However, our classification service will attempt to direct you to the appropriate regulatory framework where possible.

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.

Such requests may be presented to an internal multi-disciplinary Borderline Products 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 Borderline Products 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, and if deemed applicable, the HPRA advice in relation to the classification of medical devices.

Our Borderline Products Committee consists of HPRA staff with the appropriate scientific and regulatory expertise and experience and is chaired by the Scientific Affairs Manager.

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

Contact Us:

Classification Queries

T: +353 (0) 1 676 4971
E: classification@hpra.ie