Registered herbal medicines

herbal remedies at BootsFrom 30 April 2011, manufactured herbal medicines placed on the UK market are required to have either a traditional herbal registration or a product licence/marketing authorisation.

Licensed herbal medicines are required to demonstrate safety, quality and efficacy and be accompanied by the necessary information for safe usage. Registered traditional herbal medicines are required to meet specific standards of safety and quality and be accompanied by agreed indications, based on traditional usage, along with systematic patient information allowing the safe use of the product.  See the bottom of this page for a more detailed description of the difference between licensed and registered herbal medicines.

A number of products have now been registered under the Traditional Herbal Medicines Registration Scheme.  We first list the herb name, then the manufacturers and brand names of particular products.

Arctic rose/Golden root (Rhodiola rosea)  root and rhizome   

Dr Willmar Schwabe GmbH:  Vitano tablets

Arnica (Arnica montana)  flower heads     

Bioforce (UK) Ltd: Atrogel gel

Black cohosh (Cimicifuga racemosa)  rhizome    

MH Pharma (UK) Ltd:  Menoherb tablets

Chaste tree (Vitex agnus-castus)  fruits     

MH Pharma (UK) Ltd:  Premherb tablets

Devil’s Claw (Harpagophytum procumbens)  rhizome   

Bioforce (UK) Ltd: Atrosan tablets;  MH Pharma (UK) Ltd: Flexiherb tablets

Echinacea (Echinacea purpurea)  root          

A Nelson & Co: Duchy Herbals Echina-Relief Tincture;  Natures Aid Health: Echineeze Tablets          

aerial parts    

Swiss Caps GmbH:  Echinaflu tablets, Echinaflu capsules

Feverfew (Tanacetum parthenium)  aerial parts    

MH Pharma (UK) Ltd:  Migraherb capsules

Horse chestnut (Aesculus hippocastanum)  seeds    

Bioforce (UK) Ltd: Venaforce tablets

Kaloba (Pelargonium sidoides)  roots     

Dr Willmar Schwabe GmbH:  Kaloba oral drops

Saw palmetto (Seronoa repens)  fruit      

Bioforce (UK) Ltd: Prostasan  capsules

St John’s Wort (Hypericum perforatum)  flowering tops   

A Nelson & Co: Duchy Herbals:  Hyperi-lift tincture; Bioforce (UK) Ltd: Hyperiforce tablets;  Pascoe Pharmazeutische Praparate GmbH: Botanova tablets; MH Pharma (UK) Ltd: Hypericalm tablets.

Valerian (Valeriana officinalis)  root      

MH Pharma (UK) Ltd: Niteherb tablets; MH Pharma (UK) Ltd: Niteherb Plus tablets; Bio-Health Ltd: Valdrian capsules

For current information go to the Public Assessment Reports page on the MHRA website.

The difference between licensed and registered herbal medicines

Prior to the introduction of the European Traditional Herbal Use Directive, there was only one formal category of herbal product - these were licensed herbal medicines. One of the requirements for the award of a licence was that research evidence had to be supplied in order to justify the claims made. However, acquiring a herbal licence is a lengthy and expensive procedure. Recognising that many herbal products have been in use for some time, the traditional use registration allows anecdotal evidence to be taken into consideration when making therapeutic claims (as long as the herbal product has been in use for at least 30 years). As the claims are not underpinned by research evidence, there is a restriction on precisely what can be said.

 

It is not the herb that is licenced or registered but the commercial product. Licenced products can be identified by a distinctive nine number Product Licence (PL) number on the product container or packaging which is pre-fixed by the letters PL, whereas registered products can be identified by a nine digit registration number starting with the letters THR on the product container or packaging. In early 2009 only 21 herbal products have a traditional use registration number, but you can see a completely up to date picture here..

Herbalist © FIH
Herbal monographs available from the EMAC