Herbal Medicines

Information

In general, products that are sold as medicines or having medicinal properties in Ireland must be licensed by the Health Products Regulatory Authority (HPRA), prior to being placed on the market in Ireland.

Rules

Some herbal medicines do not meet the usual criteria for medicine authorisation and for this reason the European Union introduced separate rules for Traditional Herbal Medicines.

The European Traditional Herbal Medicinal Products Directive (2004/24/EC) (pdf) came into effect in Ireland on 23rd July 2007 by Statutory Instrument No. 540 of 2007. The Directive establishes a regulatory approval process for herbal medicines in the EU.

It allows for a simplified registration procedure for traditional herbal medicines that have been used for at least 30 years, including at least 15 years within the EU, and that are for use without medical supervision and without injection.

You can read more information about herbal medicines on the Health Products Regulatory Authority website where you can also search the list of authorised herbal medicines.

Where To Apply

Health Products Regulatory Authority

Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Ireland

Tel:+353 (0)1 676 4971
Homepage: http://www.hpra.ie/
Email: info@hpra.ie


Page edited: 7 July 2014