Earl Baldwin of Bewdleyasked Her Majesty's Government:
What criteria are used by the Medicines Control Agency in assessing whether a blend of herbal, vitamin and mineral supplements should be classified as a medicine; whether it is the practice of the agency to provide to manufacturers of such blends a clear statement as to their reasons for judging such a product a medicine; and, if not, why not. [HL3646]
§ Baroness HaymanIn assessing whether a product is a medicine, the Medicines Control Agency (MCA) has regard to the definition of a medicinal product found in Pharmaceutical Directive 65/65/EEC. It also has regard to legal precedent, and its guidance, (including assessment criteria), which it has published in its Leaflet MAL 8: "A guide to what is a medicinal product". On a case-by-case basis, the agency decides whether a product is presented for treating or preventing disease, or may be administered with a view to restoring, correcting or modifying physiological functions in humans.
When notifying a manufacturer that it has classified a product as a medicinal product, the MCA explains the grounds for its decision.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Whether, in assessing the status of a blend of herbal, vitamin and mineral supplements, the Medicines Control Agency gives consideration to the availability of that blend on general retail sale in other member states of the European Union. [HL3647]
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§ Baroness HaymanJudgments of the European Court of Justice have confirmed that it is for the national authorities in each member state to determine, subject to review by the courts, whether a product is a medicinal product. A recent United Kingdom Court of Appeal judgment decided that at this stage of the development of the European Community, complete harmonisation is not possible and each member state's relevant authorities have to be allowed a margin of appreciation in reaching a conclusion. The Medicines Control Agency regards a product's status in other member states as a relevant factor when coming to a decision on its classification in the United Kingdom.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Why a product containing a blend of herbal, vitamin and mineral supplements requires a medicines product licence when the different elements of that blend could each be sold separately under food law without such a licence. [HL3648]
§ Baroness HaymanA product containing a blend of herbs, vitamins and minerals whose different elements could be sold separately under food law is not considered a medicinal product by the Medicines Control Agency unless it is presented for treating or preventing disease or 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.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Whether they are aware of any representations received by the Medicines Control Agency in respect of recent contested decisions to classify products containing safe herbal, vitamin and mineral supplements as medicines requiring a product licence. [HL3649]
§ Baroness HaymanThe Medicines Control Agency (MCA) has received representations against determinations it has made that certain products containing herbs, vitamins and minerals were medicinal products and licensable. Because they are unlicensed, the MCA has not assessed their safety, quality and efficacy in terms of medicines law.
Earl Baldwin of Bewdleyasked Her Majesty's Government:
Whether they have any plans to issue further guidance to the Medicines Control Agency about the classification of products containing blends of herbal, vitamin and mineral supplements. [HL3650]
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§ Baroness HaymanThe Medicines Control Agency acts on behalf of the Licensing Authority in accordance with the Medicines Act 1968. The agency classifies products on a case-by-case basis in accordance with European Community and United Kingdom law, legal precedent and published guidance, and there are no plans to change this.