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Traditional Herbal Medicines Home We have a particular interest in traditional herbal medicines registration. It is a fascinating balance of traditional medicine and conventional scientific standards. Consider the two examples below now registered as traditional herbal medicinal products under Directive 2004/24/EC (known commonly as the THMD) which refers to Traditional Herbal Medicinal Products. Saw Palmetto registered under the THMD in the UK for the relief of lower urinary tract symptoms in men who have a confirmed diagnosis of Benign Prostatic Hypertrophy (BPH). The benefits of this herb can be traced back to the early 1700's, where natives of Florida where the plant grows, used the berries to treat similar indications. Valerian, registered under the THMD in the UK for the temporary relief of sleep disturbances due to symptoms of mild anxiety. It has been used for nervousness and insomnia for centuries in Ayurvedic medicine and in traditional Chinese medicine, and since the Middle Ages throughout Europe. Other herbs now granted registrations include sage, St Johns wort, feverfew and black Cohosh. In the UK at the beginning of 2012 the total number of herbs in all applications stands at 97 Initially simpler single ingredient western herbal were granted THRs, but increasingly there are now combinations of herbal ingredients registered and the list of differing herbs is extending to other branches of herbal medicine. Auyverdic and TCM medicines face technical challenges but should be able to achieve registration. The registration requirement to gain a traditional herbal medicine registration for this type of product is simplified as it is not necessary to prove the efficacy (that it works) for a traditional herbal medicine, only that it has been available for the required period of time. Post-marketing requirements must be adhered to once the registration is granted. Advertising must meet the required standards. Pharmacovigilance must start, and further changes for maintenance, (for example for further changes in manufacturing sites) require updating as a variation process. A renewal of the THR is also required 5 years after the initial grant. We can assist with project management and registration of such products and have valuable experience in this area. We can work with you to guide you through the necessary requirements under the Directive that you will have to comply with. We can either prepare for you or help you to prepare a submission for a traditional herbal medicinal product, including vital pre-submission discussions with the Health Authorities. |