§ Mr. MitchellTo ask the Secretary of State for Health what plans the Medicines Control Agency has to review the guidance in Medicines Act Leaflet Number 8; and what is the status of that leaflet. [61618]
§ Ms JowellThe Medicines Control Agency will review its Guidance Leaflet (Medicines Act Leaflet 8: "A Guide to What is a Medicinal Product") to reflect any changes to medicines legislation which are approved by Parliament following the conclusion of its present consultation exercise on proposals to place the classification process for "borderline products" on a statutory basis. The leaflet is for guidance only.
§ Mr. MitchellTo ask the Secretary of State for Health if a manufacturer of a blend of herbs and vitamins which is assessed by the Medicines Control Agency as medicinal by presentation is given the opportunity to review the presentation of that product prior to enforcement action being taken. [61639]
§ Ms JowellWhen notifying a manufacturer that it has determined a product is a medicine because it is presented for treating or preventing disease, the Medicines Control Agency requires compliance with the law by withdrawal of the product. The manufacturer may subsequently be able to comply with the law by placing the product on the market in a way which does not present it as treating or preventing disease.
§ Mr. MitchellTo ask the Secretary of State for Health what plans officials in(a) his Department and (b) the 208W Medicines Control Agency have to meet manufacturers of vitamin and herb blends to discuss the licensing of their products as medicines in the United Kingdom. [61669]
§ Ms JowellOfficials of the Medicines Control Agency (MCA), an executive agency of the Department, regularly meet the associations representing manufacturers of these products. When necessary, officials of the MCA also meet individual manufacturers to discuss the licensing of their products.
§ Mr. MitchellTo ask the Secretary of State for Health by what criteria the Medicines Control Agency assesses whether a blend of herbs and vitamins is medicinal by(a) function and (b) presentation; and if a manufacturer whose products are so assessed is given a written statement of the reasons for that decision. [61638]
§ Ms JowellThe Medicines Control Agency (MCA) assesses products against the definition of a medicinal product in European Commission and United Kingdom law. It also has regard to legal precedent and its own published guidance (Leaflet MAL 8: "A Guide to What is a Medicinal Product"). Broadly, the assessment of a product's functionality focuses on the pharmacological effect of its ingredient(s) on human physiology, while the assessment of a product's presentation considers a whole range of factors, including any claims made for the product in promotional material or on its labelling and packaging (whether explicit or implied), its name, the form, and the consumers targeted. The MCA also considers the opinion of the product's purpose an averagely well informed consumer would gain from its ingredient(s) and presentation. It is normal practice for the MCA to explain to the manufacturer the grounds for a classification decision.
§ Mr. MitchellTo ask the Secretary of State for Health if the Medicines Control Agency consults independent scientific experts when considering whether a herb and vitamin blend is medicinal by function; and if the manufacturer of such a product is able to have access to expert advice obtained by the agency. [61637]
§ Ms JowellThe Medicines Control Agency (MCA) generally relies on the objective and expert advice of its own medical and pharmaceutical assessors. However, there are occasions when taking advice from external experts is appropriate. The MCA informs manufacturers of the impact of expert advice when classifying their products.