§ Dr. IddonTo ask the Secretary of State for Health for what reasons a medicines product licence may be required for a product which is a blend of two ingredients neither of which would require a product licence, if sold separately. [79487]
§ Ms JowellA product containing two or more ingredients which, if sold separately, would not come within medicines legislation is not classified by the Medicines Control Agency as a licensable medicinal product unless it is presented for treating or preventing disease or, not being a food or toilet preparation, it may be administered with a view to restoring, correcting or modifying physiological functions in humans. However, where a herbal product—whether or not it includes non-herbal substances—is classified as a medicinal product, it will be subject to medicines legislation. Herbal remedies, accordingly, require a marketing authorisation unless they are exempt from licensing under the terms of Section 12 of the Medicines Act 1968. Section 132 of the Act makes it clear that the exemption for herbal remedies does not extend to products which contain active non-herbal substances.
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