The Traditional Herbal Medicinal Products Directive (2004/24/EC) was transposed into Irish law in 2007. This requires all products containing herbal substances coming onto the market after this time either to be authorised as for conventional medicines or to be registered under the Traditional Herbal Medicines (THM) scheme provided for by the Directive.
From 30 April 2011, products that have not been either authorised or registered as THMs can no longer be lawfully marketed in Ireland. The IMB is in the process of moving to fully regulate the Irish market. Those herbal medicines which were subject of applications for THM registration as of the time of 30 April 2011 have been allowed to remain on the market pending the completion of the assessment process
The assessment process has been taking a long time, generally because of the poor quality of dossiers received. As of 1 August 2012, six traditional herbal medicinal products have been registered using the new scheme and can be found on the IMB human medicines listing section. The easiest way to search for these is to use the advanced search facility and include the letters TR (Traditional Registration) in the licence number box. This will display all of the approved products which carry a TR number. Once the products have been registered by the IMB they will be allowed on to the market and the packaging will have appropriate labelling including the TR number.
To supplement the information available on the Traditional Herbal Medicinal Products Registration Scheme, the IMB has also produced two lists for illustrative purposes of herbal substances which can be and have been accepted for inclusion in Traditional Herbal Medicinal Products and the second list of herbs which, for various reasons, are not considered to be acceptable in THMPs. This second list includes herbs which are known to be toxic and therefore require medical supervision for their use. The existence
of these lists has also been helpful in discussing with our colleagues in the Food Safety Authority which herbal substances are considered to be medicinal and which others may be acceptable for inclusion in food supplements when no medicinal claims are made on the label.
Products containing echinacea
In the context of the discussion on the generation of the lists, the IMB has identified that products containing echinacea are primarily of use as medicinal products and should not be marketed in Ireland as food supplements. The IMB is working closely with the Food Safety Authority to ensure that such products will only be marketed as medicinal products in the future.
In the course of the assessment of products containing echinacea, the IMB reviewed all information available regarding the safety and efficacy of products containing this herbal substance. The available safety data as well as guidance from the CHMP at the European Medicines Agency (EMA) were evaluated. Following this evaluation, the IMB concluded that the use of echinacea can be associated with rare side effects, mainly allergic reactions which in some cases may be severe. This review has led the IMB to conclude that the use of products containing echinacea is no longer recommended in children under twelve years of age.
The IMB has taken the view that there are potential risks associated with the use of echinacea containing products in children under twelve years of age and there is limited evidence of benefit in this age group. Consequently, products containing echinacea specifically intended for use in children will no longer be acceptable on the Irish market and other products containing echinacea will be labelled accordingly to remove any references to use in children. While this is not considered a serious safety issue, nevertheless, these measures are being taken as a precaution, as with all medicines, to maximise the benefits of use and reduce the risks to users.
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