§ Mr. David Marshallasked the Secretary of State for Social Services what regulations govern the sale, marketing, prescription by doctors and use of drugs without a product licence; and if he will make a statement.
§ Mr. HayhoeThe primary and subordinate legislation which allows medicinal products to be manufactured, sold or supplied without a product licence in particular circumstances is as follows: 267W
The Medicines Act 1968: section 9 (exemptions for doctors, dentists, etc); section 10 (exemptions for pharmacists); and section 12 (exemptions in respect of herbal remedies);The Medicines (Exemption from Licences) (Foods and Cosmetics) Order 1971 (SI 1971 No. 1410) (as amended);The Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971 (SI 1971 No. 1450) (as amended);The Medicines (Exemption from Licences) (Special Cases and Miscellaneous Provisions) Order 1972 (SI 1972 No. 1200) (as amended);The Medicines (Exemption from Licences) (Clinical Trials) Order 1974 (SI 1974 No. 498);The Medicines Exemption from Licences) (Ingredients) Order 1974 (SI 1974 No. 1150); andThe Medicines (Exemption from Licences) (Clinical Trials) Order 1981 (SI 1981 No. 164).