§ Mr. Austin MitchellTo ask the Secretary of State for Health what estimate he has made of the costs arising to manufacturers from(a) Medicines Control Agency fees, (b) the costs of document preparation, (c) the storage of batches for testing, (d) analysis cost and (e) annual licence fees for (i) a simple herbal product with one ingredient and (ii) a complex herbal product containing several ingredients, in connection with the submission of applications for registration under the provisions of the Traditional Herbal Medicinal Products Directive. [84210]
§ Ms BlearsThe proposed Directive on Traditional Herbal Medicinal Products is under negotiation and at this stage it is not yet possible to identify detailed costs. However, under the current proposals it should not be necessary for companies to demonstrate the efficacy of the product and where products comply with the proposed European positive list, it will not be necessary to provide evidence of safety or traditional use either. We would expect that to be reflected in the fee levels for a traditional use registration. Any proposed fee levels 965W will need to be agreed by Ministers and will be the subject of public consultation before they are put before Parliament.
We welcome the stated intention of the herbal forum, a group which represents all the United Kingdom manufacturing trade associations operating in the herbal sector, to have constructive discussions with the Medicines Control Agency on a wide range of detailed practical issues relating to negotiations on the Directive and its implementation should the Directive be agreed. A key aim of these discussions will be to identify ways to contain regulatory impact, consistent with protecting public health.