Why is it a THR medicine?
New Herbal Range available for first time in UK as registered Medicine
A new range of herbal medicinal treatments is one of the first in the UK to be granted registration by the government’s Medicines and Healthcare Products Regulatory Agency (MHRA), as traditional herbal medicinal products. The range includes Kaloba®, Karma®, MenoHerb®, FlexiHerb®, PremHerb®, MigraHerb®, Vitano®, NiteHerb®, RelaxHerb® and EchinaCold®.
The Schwabe range of herbal medicines has been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:
- Herbal products are regulated and meet specific standards of safety and quality based on traditional usage
- Products must be of pharmaceutical quality and also be manufactured to European Good Manufacturing Practice (GMP) Guidelines
- All herbal medicines registered under this scheme have a nine digit registration number on their packaging starting with the letters THR
Dr Dick Middleton, Technical Director at Schwabe Pharma UK says,
“We are thrilled that our range of herbal medicines is among the first to be registered under the Traditional Herbal Registration Scheme, as this is an exciting step forward for the natural health industry. Traditional use of these herbs over more than 30 years has shown that consumers throughout the UK and Europe value these herbal products and find them helpful in managing their healthcare needs. Disillusionment with conventional medicine treatments has led to increasing consumer interest in Complementary Medicine and the availability of these products gives consumers more choice and ensures that what they are buying meets European pharmaceutical standards of quality and safety and has appropriate and independently assessed consumer information on the pack and in the leaflet.”
Traditional Use – what this means under the THRS
A herbal medicine registered under THRS can make medicinal claims on the basis of evidence of traditional use. This means that the licence holder must show the safety of their herbal medicine by providing bibliographic proof of at least 30 years of long-standing use for the indication - although many products have evidence of hundreds of years of herbal usage. Schwabe’s preferred partner for providing the required dossiers and the “evidence of tradition” is Diapharm.
What does THRS mean for the consumer?
The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer consumers reassurance about these products. The registration of herbal products under the THRS scheme provides this reassurance to consumers and healthcare professionals that products assessed by the MHRA meet the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that a product has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.
The Schwabe range of registered products includes:
- Kaloba® - used for the relief of symptoms of upper respiratory tract infections including common cold, such as sore throat, cough and blocked or runny nose†
- Karma® - used to relieve the symptoms of slightly low mood and mild anxiety†
- MenoHerb® - used for the relief of symptoms of the menopause, such as hot flushes, night sweats and temporary changes in mood (such as nervous irritability and restlessness)†
- FlexiHerb® - used for relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints†
- PremHerb® - used for the relief of symptoms of associated with premenstrual syndrome†
- MigraHerb® - used for the prevention of migraine headaches in people with a diagnosis of migraine†
- Vitano® - used for the temporary relief of symptoms associated with stress such as fatigue, exhaustion and mild anxiety†
- NiteHerb® - used for the relief of sleep disturbances due to symptoms of mild anxiety†
- RelaxHerb® - used for the relief of the symptoms associated with stress, such as mild anxiety
- EchinaCold® - used for the relief of symptoms of the common cold and influenza type infections†
† exclusively based upon long-standing use as a traditional remedy. Always read the label.
There are currently 17 herbal medicines in the UK which hold a THR licence, more than half of which are owned by Schwabe Pharma (UK) Ltd. The new THR regulations require that all unlicensed medicinal herbal remedies are registered under the scheme by 2011.