Herbal Medicines

Herbal medicines sold in the European Union (EU) are required to be approved prior to being placed on the market. This is to ensure that herbal medicines are of acceptable safety and quality. Information for patients and the public, healthcare professionals and anyone wishing to place herbal medicines on the Irish market can be found in this section of our website.

The European 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 establishes a regulatory approval process for herbal medicines in the EU. It requires each EU Member State to set up a traditional herbal registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision. This is a simplified registration procedure for herbal medicines with a history of traditional use and acceptable safety and quality. A registration will be called a traditional-use registration and will be allocated a TR number. You can search for authorised Traditional Herbal Medicinal Products here by entering TR in the licence number box. 

Information for Members of the Public and Healthcare Professionals

This document includes information about herbal medicines legislation, why it was introduced and how it impacts those who use herbal medicines.

Consumer Q&A Document


Information for Industry

Guidance Document

This document provides information on the requirements for the approval of herbal medicines and traditional herbal medicines:

Guide to Traditional Herbal Medicinal Products Registration Scheme

 

Questions and Answers Document

Industry Q&A Document 

This Q&A document includes three sections as follows:

  • Introduction to the Traditional Herbal Medicinal Product Directive (2004/24 EC); 
  • Health Products Regulatory Authority position regarding the ending of the transition period for registration of traditional herbal medicinal products; 
  • The Committee for Herbal Medicinal Products.

 

Update from May 2010

An update on the requirements for the authorisation or registration of herbal medicinal products was published by the HPRA (then the IMB) in May 2010:

Update on Herbal Medicinal Products - May 2010

 

Further Information

Further information on the regulation of herbal medicines, including the registration of traditional herbal medicines, is available from the Europa.eu website.