Herbal medicinal products have become popular for self medication in the treatment of minor medical conditions. The growing public demand for herbal medicinal products and the associated increase in their use is evident. Effective regulation of herbal medicinal products is considered necessary in order to ensure that safe products of appropriate quality continue to be available in pharmacies, health food stores and other retail outlets.  

There are two routes available to license herbal medicinal products in Ireland:  

• A Marketing Authorisation [MA] (as per article 8(3) for a full authorisation or article 10a for well-established use authorisation, of Directive 2001/83/EC as amended). Products in this case must be able to demonstrate appropriate standards of quality, safety and efficacy and be accompanied by the necessary information for safe use. For more detail on products in this category please see the Human Medicines Licensing section of the IMB website  
• A Certificate of Traditional-use Registration (as per article 16a of Directive 2001/83/EC as amended). Products in this category are registered under the Traditional Herbal Medicinal Products Registration Scheme and are known as traditional herbal medicines. For more details on products in this category see below. 

 
Traditional Herbal Medicines
A significant number of medicinal products despite their long tradition of use do not fulfill the requirements of a well-established medicinal use, with recognised efficacy and acceptable levels of safety and therefore cannot fulfill the requirements for a full MA. For this reason, specific provisions were introduced for traditional herbal medicinal products in accordance with the Traditional Herbal Medicinal Products Directive (2004/24/EC). This directive has now been transposed into Irish law by the Department of Health and Children [DoH&C]. The Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007) were implemented on 23rd July 2007 by the Minister for Health and Children.  

This legislation is designed to provide an appropriate legal framework for placing traditional herbal medicinal products on the market within the European Community. It introduces a simplified registration procedure the Traditional Herbal Medicinal Products Registration Scheme.  

The DoH&C designated the IMB as the competent authority for implementation of this legislation and on this basis the IMB has established the Traditional Herbal Medicinal Products Registration Scheme. Under this registration scheme an applicant can apply for a certificate of traditional-use registration for their traditional herbal medicinal product. A registration will be called a traditional-use registration and will be allocated a TR number.  

A traditional herbal medicinal product is a product that fulfills the following criteria (according to Directive 2004/24/EC):

• intended and designed for use without the intervention of a medical practitioner for diagnosis, prescription or monitoring of treatment. 
• taken orally, for external use or inhalation. 
• administered exclusively at a specified strength and dose. 
• on the market for a ‘period of traditional use’. 

 
Timeframe for implementation of the regulations/Transition period
The regulations state that no medicinal product can be placed on the market without a prior marketing authorisation or certificate of traditional-use registration. The regulations provide an exemption from this requirement until 30th April 2011 for traditional herbal medicinal products that were on the market in the State on the coming into force of the regulations.  

In order to ensure that relevant products hold either an MA or a certificate of traditional-use registration by the 30th April 2011, potential applicants should be aware that the new regulations also include a provision for the IMB to establish dates by which applications for traditional-use registration must be submitted.  

For guidance on making an application to the Traditional Herbal Medicinal Products Registration Scheme please click here.

Further information on the traditional herbal medicines is available in our Frequently Asked Questions (FAQ).

Public consultation process on herbal substances classification