The Medicines and Healthcare products Regulatory Agency (MHRA) granted Rutland Biodynamics Ltd a Traditional Herbal Registration Certificate for the traditional herbal medicinal products English Herbal Medicines Valerian Relaxisleep, Herbs Hands Healing ValRelax, Brooke Green Valerian Elixir and Swiss Herbal Remedies Valerian Elixir. These products are identical to each other apart from the difference in product name and will be collectively referred to as Valerian Oral Liquid. Valerian Oral Liquid (Traditional Herbal Registration number: THR 28255/0017) is available without prescription and can be bought from pharmacies and other outlets.
Valerian Oral Liquid is used for the temporary relief of symptoms of mild anxiety and to aid sleep, based on traditional use only. The active ingredient of this product comes from the roots of the Valerian plant, which is also known as Valeriana officinalis L.
This registration is based exclusively upon evidence of traditional use of Valerian as a herbal medicine and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration scheme to prove scientifically that the product works.
No new or unexpected safety concerns arose from this application and it was, therefore, decided that a Traditional Herbal Registration Certificate could be granted.