Directive 2004/24/EC has been implemented into Irish law by the Medicinal Products (Control of Placing on the Market) Regulations, 2007. The Irish Medicines Board (IMB) is the designated competent authority in Ireland for implementation of this legislation. The IMB has established the traditional herbal medicinal products registration scheme, under which applications may be made for granting a certificate of traditional-use registration to herbal medicines. Herbal Medicines must now be manufactured under Good Manufacturing Practice (GMP) to ensure the quality and safety of the product. The IMB is currently engaged in the registration of herbal medicinal products.
An exceptionally long transition period of 7 years, allowing for the registration of traditional herbal medicines already on the market, ended in April 2011. Since 2004, the IMB has published guidance documents for consumers and for the herbal medicines industry, to assist those making applications under the Traditional Herbal Medicinal Products Registration Scheme. The IMB has also held information sessions for stakeholders on the requirements for the registration scheme and regularly meets with potential applicants to provide further guidance on the Traditional Herbal Medicinal Products Registration Scheme as required. During 2010, the IMB established a public consultation on herbal substances classification to give greater clarity to the industry as to whether products should be placed on the market as herbal medicinal products or as food supplements.