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The Traditional Herbal Medicinal Products Directive
With the growing popularity of herbal medicines over the past 15 years, many brands have entered the market. Bioforce has long been at the forefront of herbal research, balancing traditional herbal knowledge with scientific trials. We grow herbs organically ensuring that the freshest material, rich in active substances, is used in our remedies which are manufactured to Good Manufacturing Practice standards (GMP).
Not all brands are equal in quality or in how they are manufactured and researched. Until now there has been no practicable way to register or licence herbal products in the UK; no way for the consumer to know which products are produced to the appropriate quality.
The Traditional Herbal Medicinal Products Directive was introduced in October 2005 to enable the medical licensing of herbs. To achieve a successful submission to the Medicines and Healthcare Regulatory Authority (MHRA) it is necessary for a manufacturer to develop a dossier containing proof of a product’s traditional use, its safety and its quality – a lengthy and expensive process. If successful, a licence will be issued for that product, and medicinal claims based on traditional use may then be made for it in relation to conditions that do not require attention from a doctor.
The safety standards are rigorous and, on the quality side, pharmaceutical standards apply, so manufacturers must operate to GMP standards, as well as having Quality Control procedures, and Qualified Persons for both GMP and Pharmacovigilance continuously available to them.
The Traditional Herbal Medicine licence allows more information on the label and leaflet, helping customers to choose the appropriate product - customers who can be assured that they are getting what a product says on the label, throughout its shelf life
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