§ Norman BakerTo ask the Secretary of State for Health for what reason silicofluoride chemicals classified as medicinal substances under the Codified Pharmaceutical Directive are, exempt from such classification by the Medicines Control Agency when used as an additive to public water supplies. [85840]
§ Mr. LammyThe inclusion of silicofluoride chemicals in a product does not necessarily make that product a medicinal product. Silicofluoride has many different uses and can therefore be subject to a number of different regulatory regimes. For example, various forms of fluoride can be included in oral hygiene products under the Cosmetic Products (Safety) Regulations and some forms of fluoride will be permitted in food supplements through the forthcoming Food Supplements (England) Regulations. The decision as to whether a particular product is a medicinal product is made by the Medicines Control Agency using the definition of that term in Article 1 of Directive 2001/83, relevant legal precedent and its own published guidance. The MCA considers that neither fluoride added to drinking water nor the resulting fluoridated water are medicinal products which require marketing authorisations as medicines.