Herbal medicinal products on the Irish market must be either authorised or registered with the HPRA.
The Traditional Herbal Medicinal Products Directive (2004/24/EC) came into effect in Ireland on 23 July 2007 (S.I. No. 540 of 2007). The Directive established a regulatory approval process for herbal medicines in the EU. It requires each EU Member State to set up a registration scheme for traditional herbal medicines that are suitable for use without medical supervision. This is a simplified registration procedure for herbal medicines which have a history of traditional use and are of acceptable safety and quality. Products approved for traditional-use registration are allocated a TR number. You can search for traditional herbal medicinal products here.
If a herbal medicinal product does not meet the criteria for registration as a traditional herbal medicinal product (THMP), it can still be granted a marketing authorisation in the same way as non-herbal medicines. Information on this procedure is available on the HPRA website here.
Information for the public, healthcare professionals and anyone wishing to place THMPs on the Irish market can be found in this section of our website.
Information for Members of the Public
This webpage provides information for the public about herbal medicines legislation, outlines the background to the current system of regulation and explains how it affects those who use herbal medicines.
Information for the public
Information for Retailers
This webpage provides information for retailers, including pharmacists.
Information for retailers
Information for Industry
This guidance document provides information for industry on traditional herbal medicines:
Guide to Traditional Herbal Medicinal Products Registration Scheme
Information for Herbal Practitioners
The supply of a herbal preparation by a herbal practitioner, on foot of a personal consultation, is not seen as the placing of a herbal medicinal product on the market and such preparations do not necessarily require registration/authorisation by the HPRA.
It should be noted, however, that some herbal substances are controlled under the Medicinal Products (Prescription and Control of Supply) Regulations 2003, as amended.
The HPRA does not regulate the activities of herbal practitioners and all queries on this area should be addressed to the Department of Health.
Contact Details and Useful Links
Contact details and regulatory partners
Email for general queries in relation to herbal medicinal products: firstname.lastname@example.org.
Email for queries concerning importation, manufacture and/or distribution of medicinal products: email@example.com.
Queries concerning herbal practitioners or alternative medicine practitioners should be directed to the Department of Health.
Queries concerning food and food supplements should be directed to the Food Safety Authority of Ireland (FSAI).
Traditional Herbal Medicinal Products currently registered by the HPRA can be found on the HPRA website here.
Information in relation to classification of medicines can be found on the HPRA website here. This includes the relevant contact details.
European Traditional Herbal Medicinal Products Directive: 2004/24/EC.
National legislation: S.I. No. 540 of 2007.
Herbal monographs and list entries published by the Committee on Herbal Medicinal Products (HMPC) are available from the European Medicines Agency (EMA) website.