§ Chris GraylingTo ask the Secretary of State for Health what estimate he has made of the number of products currently on the market that will require a full marketing authorisation under the Traditional Herbal Medicinal Products Directive. [143660]
§ Miss Melanie JohnsonOne of the main reasons why we have supported the development of the proposed Directive on Traditional Herbal Medicinal Products is the difficulty companies sometimes experience at present in providing evidence that their products fully satisfy all the criteria for a marketing authorisation, and in particular the requirements relating to efficacy.
889WThe current text of the proposed Directive provides that, where the competent authorities judge that a traditional herbal medicinal product fulfils the criteria for a marketing authorisation, the product will not be eligible for a traditional use registration. Our view is that it is likely that only a very small proportion of unlicensed herbal remedies currently on the United Kingdom market would be affected by this provision in a situation where an applicant was seeking a traditional use registration. However, it is not practicable for the Medicines and Healthcare Products Regulatory Agency to give a more specific estimate in advance of the launch of the proposed traditional use registration scheme or to conduct a detailed survey that would be burdensome to the industry.