§ Mr. ElletsonTo ask the Secretary of State for Health if she will make a statement on the operation of the Medicines Act (Exemptions from Licences) (Importation) Order 1984—SI, 1984, No. 673—in relation to named patient arrangements for the supply of unlicensed factor 8 preparations and other unlicensed pharmaceutical products.
§ Dr. MawhinneyApplications for the import of unlicensed factor 8 as with all unlicensed medicines are subject to the provisions of SI 1984 No. 673—the Medicines (Exemption from Licences) (Importation) Order. This makes provision to meet a need for a particular product where there is no equivalent licensed product available on the United Kingdom market or if such a licence has been granted, the medicinal product is not in practice available.
Sale or supply of exempted products is restricted to the conditions specified in the order.
Each import exemption is limited to a quantity not exceeding that sufficient for 25 single administrations or for 25 courses of treatment not exceeding three months.
In deciding whether or not to allow importation the Medicines Control Agency considers: the facilities and conditions relating to manufacture, the quality of material being imported and whether the medicinal product can be regarded as a product which can be safely administered to human beings or whether the product is of satisfactory quality for such administration.