Classification of human health products

We offer a service to stakeholders to clarify the appropriate regulatory category for products that are borderline between human medicines, medical devices and other regulated products, such as cosmetics.

Not all products fall under our remit from a regulatory perspective (e.g. food products are regulated by the Food Safety Authority of Ireland). However, our classification service will attempt to direct you to the appropriate regulatory framework.

Information on the definition of a medicinal product and examples of borderline products can be found in our Guide to definition of a human medicine. A copy of this Guide is available below on this page.

How to make a classification request

Please read the Guide to definition of a human medicine before applying, as it may assist you in determining the classification yourself.

To make a classification request, please complete the Request for classification of a human health product form. A copy of this form is available below on this page. Please note that fees apply. 

You can submit classification queries and requests classification@hpra.ie. 

Review process

Product classification requests may be presented to an internal multi-disciplinary Borderline Products Committee.

The outcome is communicated promptly to the enquirers, along with any recommendations for action depending on the specific circumstances of the case.

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.

Full details of the procedure can be found in our Guide to the Definition of a Human Medicine.