This Order amends the Medicines (Pharmacy and General Sale—Exemption) Order 1980 and provides, in new articles 4A and 4B and Schedule 3, for exemptions from sections 52 and 53 of the Medicines Act 1968 for the supply of a medicinal product for human use by—
a specified national health body, where the product is supplied for the purpose of being administered in accordance with the patient specific directions of a doctor or dentist, or is supplied by a designated health professional belonging to a class specified in Schedule 3 to the Order for the purpose of being administered in accordance with a Patient Group Direction (i.e. a written direction providing for the supply and administration of a description or class of product to persons generally), where the Direction is signed by a doctor or a dentist and by a pharmacist, and certain other conditions are fulfilled;
a designated health professional, in order to assist a doctor or a dentist in the provision of national health services, where the product is supplied for the purpose of being administered in accordance with a Patient Group Direction and the conditions referred to in (a) are fulfilled.
An assessment of the cost to business of complying with this Order has been made, copies of which have been placed in the libraries of both Houses of Parliament. Further copies may be obtained from the Department of Health, Medicines Control Agency, Information Centre, Room 10-202, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.