Starting in May 2011 all traditional herbal medicinal products (THMPS), will require a marketing authorisation or certificate of traditional-use registration before being placed on the EU or Irish market. Any herbal medicinal products already on the market that have not received or applied for registration by the end of April 2011, will be considered unlicensed and will have to be removed from sale.

Despite this, current supplies of unauthorised traditional herbal medicinal products at importer and wholesaler level will be allowed to sell through, so you shouldn't expect an immediate shortage of your favorite herbal remedy. The Irish Medicines Board (IMB), who have been designated as the competent authority in Ireland for implementation of this legislation, have said that they expect the current stock to be rundown by the end of this year.

The Traditional Herbal Medicinal Products Registration Scheme was introduced as part of the national regulations, Medicinal Products (Control of Placing on the Market) Regulations
2007 (S.I. No. 540 of 2007), on foot of the EU Directive 2004/24/EC, on the 23rd of July
2007.

Given the long-standing tradition of use of many of the herbal remedies, the registration process for THMPS has been greatly simplified, while still providing the necessary guarantees of quality, safety and efficacy, which is the main aim of this legislation.

Any herbal product will be considered to be medicine, where it is presented as having properties for treating or preventing disease in human beings (makes a health claim) or where it has a pharmacological, immunological or metabolic action.

In order to clarify the status of some of the products the IMB have compiled a List of herbal substances which may be acceptable for inclusion in food supplements as long as they don't make a health claim. Here you will find many popular herbs such as Evening primrose (Oenothera biennis), Korean ginseng (Panax ginseng), Passionflower (Passiflora incarnata), Guarana (Paulinia cupana), Milkthistle (Silybum marianum) and Marsh mallow (Althaea officinalis). We expect many manufacturers to avail of this option and continue to sell their herbal products as food supplements, rather then go through the registration process.

The IMB have also prepared a List of herbal substances which will be considered as medicinal products and will not be permitted in foods or food supplements. The most notable herbs on this list are Black Cohosh (Cimicifuga racemosa), Devil's claw (Harpagophytum procumbens), St John's Wort (Hypericum perforatum), Saw Palmetto (Serenoa repens), Mistletoe (Viscum album), Valerian (Valeriana officinalis) and Feverfew (Tanacetum parthenium). The companies will now have to apply and pay for registration or remove these products from sale. This will likely result in a temporary shortage and/or a reduction in the number of different brands on offer in Irish pharmacies and healthfood stores.

L.G.