§ Mrs. GillanTo ask the Secretary of State for Health what pharmaceutical production and testing standards will be imposed on herbal remedies by the proposed Traditional Herbal Medicinal Products Directive. [88687]
§ Ms BlearsThe production and testing standards under the proposed Directive on Traditional Herbal Medicinal Products would be those which apply to herbal medicines with a marketing authorisation, but modified to the extent that there would not be a328W requirement to demonstrate the efficacy of a product for which a traditional use registration was sought. The proposed requirements are intended to provide appropriate consumer protection, for example, by ensuring that the correct ingredients of appropriate quality and free from unacceptable levels of contamination are used and that the proposed shelf life of the product can be supported. The specific requirements include meeting European guidelines on Good Manufacturing Practice for herbal medicines and compliance with the European Pharmacopoeia monographs for products of herbal origin.