Traditional Herbal Medicines Registration - Industry Q&A Document
28 December 2011
This document includes questions and answers relating to the European Union’s Traditional Herbal Medicinal Products Directive (2004/24/EC).
First published in April 2011, it has now been updated (Version 2) to inform manufacturers, wholesalers, importers and retailers of their requirements under the Traditional Herbal Medicinal Products Registration Scheme from 1 January 2012 onwards.
This directive was transposed into Irish law by the Department of Health and Children with the introduction of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. 540 of 2007 as amended).
These regulations state that since 23 July 2007, 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 30 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 regulations.
The Q&A document includes three sections as follows:
- Introduction to the Traditional Herbal Medicinal Product Directive (2004/24 EC);
- Irish Medicines Board position regarding the ending of the transition period for registration of traditional herbal medicinal products;
- The Committee for Herbal Medicinal Products.
Download Industry Q&A Document
Further information regarding the registration of traditional herbal medicines is available here.