FIRST PRODUCT REGISTERED UNDER UK'S NEW HERBAL DRUG DIRECTIVE

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first product registration under the new European Directive on traditional herbal medicinal products.

Under the directive all manufactured traditional herbal medicines placed on the market will now have to meet certain requirements. For example, products are required to meet assured standards of quality, safety and patient information. There is transitional protection until 2011 for products that were legally on the UK market before April 2004. The MHRA expects a progressive build up in the number of products registered by 2011.

Currently most herbal medicines on the UK market are unlicensed, and standards in this sector vary greatly. There are also a number of licensed herbal medicines that are made to assured standards.

The first product to be registered is Atrogel Arnica Gel, an arnica gel traditionally used for the symptomatic relief of muscular aches and pains, stiffness, sprains, bruises and swelling after contusions. The product registration has been granted to Bioforce.

The directive can be viewed at www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=95.