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Herbal medicines have become popular for self medication in the treatment of minor medical conditions. The growing public demand for herbal medicines and the associated increase in their use is evident. Effective regulation of herbal medicines 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 medicines 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 Licensing section.
A Traditional Herbal Medicines 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.
A significant number of medicines 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 medicines in accordance with the Traditional Herbal Medicinal Products Directive (2004/24/EC). This directive was transposed into Irish law by the Department of Health and Children. The Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007) were implemented on 23 July 2007 by the then Minister for Health and Children.
The directive is designed to provide an appropriate legal framework for placing traditional herbal medicines on the market within the European Union. It introduces a simplified registration procedure - the Traditional Herbal Medicinal Products Registration Scheme.
For further information, visit the Traditional Herbal Medicine Registration section of our website.