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 fulfil 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.
Traditional Herbal Medicinal Products Registration Scheme
The above legislation is designed to provide an appropriate legal framework for placing traditional herbal medicinal products on the market within the European Union. 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 fulfils 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’.
European Union Q&A
The EU has published a questions and answers document focused on the registration of traditional herbal medicinal products. Download this document from the Europa.eu website.
IMB Guidance for Industry (updated 28 December 2011)
The IMB has published a guidance document to assist those making an application under the Traditional Herbal Medicinal Products Registration Scheme. Originally published in August 2007, this document has been revised to include pharmacovigilance requirements for traditional herbal medicinal products.
In addition, the IMB has published a related Q&A document. First issued in April 2011, this document has been updated (28 December 2011) to inform manufacturers, wholesalers, importers and retailers of their requirements under the scheme from 1 January 2012 onwards.
The Q&A document focuses on three main topics:
- Introduction to the Traditional Herbal Medicinal Product Directive (2004/24 EC);
- IMB position regarding the ending of the transition period for registration of traditional herbal medicines;
- The Committee for Herbal Medicinal Products.
The IMB also held an information session focusing on the registration scheme in February 2008.
Information for Consumers
This consumer Q&A document includes information about the traditional herbal medicines legislation, why it is being introduced and how it might impact those who use herbal medicines.
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. This date marks the ending of the transition period for unlicensed traditional herbal medicinal products which were on the Irish market at the time of coming into force of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007).
Details of the IMB position regarding the ending of the transition period for registration of traditional herbal medicines are included in our Q&A document. This document has been updated (28 December 2011) to inform manufacturers, wholesalers, importers and retailers of their requirements under the the Traditional Herbal Medicinal Products Registration Scheme from 1 January 2012 onwards.
Herbal Substances Classification
In order to facilitate the registration process, and to give greater clarity to companies as to whether their products can be placed on the market as traditional herbal medicines or as other categories, the IMB has published two lists of herbal substances:
(1) Those that can be accepted in traditional herbal medicinal products; and
(2) Those which cannot be marketed as traditional herbal medicinal products.
Substances mentioned in list (2) above are not acceptable for inclusion in herbal medicinal products, and by extension in food supplements, in the circumstances indicated in the table. This is because these herbal substances are generally considered to be more appropriately classified as prescription only medicines or because they are considered to be potentially too toxic for usage by patients or other users.
Herbal substances which are listed in list (1) above, or those substances not mentioned on either list, might be considered acceptable for inclusion in products which could be regulated as food supplements where no medicinal claim is made. Such products would need to be notified to the Food Safety Authority of Ireland who will provide further information on herbal substances permitted in foods.
These two lists should not be considered exhaustive or indeed legally binding and may be added to or deleted from as more experience is gained.
Any queries in relation to the Traditional Herbal Medicinal Products Registration Scheme can be emailed to email@example.com