MEDICINES Citation, commencement and interpretation 1 1 This Order may be cited as the Medicines (Pharmacy and General Sale—Exemption) Amendment Order 2003 and shall come into force on 4th April 2003. 2 In this Order, “the principal Order ” means the Medicines (Pharmacy and General Sale—Exemption) Order 1980 . Amendment of article 1 of the principal Order 2 In article 1 of the principal Order (citation, commencement and interpretation), in paragraph (2), in sub-paragraph (a)— a after the definition of “health authority”, insert the following definition— “health care” means services for or in connection with the prevention, diagnosis or treatment of disease; ; b after the definition of “homoeopathic certificate of registration” , insert the following definitions— “independent clinic”— in relation to England and Wales, has the meaning given by section 2(4) of the Care Standards Act 2000 , and in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001 ; “independent hospital”— in relation to England and Wales, shall be construed in accordance with section 2(2), (3) and (6) of the Care Standards Act 2000, and in relation to Scotland, means— an independent hospital, or a private psychiatric hospital, as defined by section 77(1) of the Regulation of Care (Scotland) Act 2001; “independent medical agency”— in relation to England and Wales, has the meaning given by section 2(5) of the Care Standards Act 2000, and in relation to Scotland, has the meaning given by section 77(1) of the Regulation of Care (Scotland) Act 2001; ; c after the definition of “ NHS trust” , insert the following definition— “nursing home” has the meaning given by article 16 of the Registered Homes (Northern Ireland) Order 1992 ; ; d after the definition of “Primary Care Trust” , insert the following definition— “prison service” means— in relation to England and Wales, a Minister of the Crown exercising functions in relation to prisons (within the meaning of the Prison Act 1952 ), in relation to Scotland, the Scottish Ministers exercising functions in relation to prisons (within the meaning of the Prisons (Scotland) Act 1989 ), and in relation to Northern Ireland, the Northern Ireland Department exercising functions in relation to prisons (within the meaning of the Prison Act (Northern Ireland) 1953 ); ; e after the definition of “registered ophthalmic optician”, insert the following definition— “registered provider” means— in relation to an independent hospital, an independent clinic or an independent medical agency— in relation to England and Wales, the person who is registered under Part II of the Care Standards Act 2000 as the person carrying on the establishment or agency, in relation to Scotland, the person who is registered under Part 1 of the Regulation of Care (Scotland) Act 2001 as the person providing the establishment or agency, and in relation to a nursing home, the person registered under Part III of the Registered Homes (Northern Ireland) Order 1992 as the person carrying on the nursing home, other than a manager who is to be treated as carrying on the home by virtue of article 17(2) of that order; “relevant manager” means— in relation to an independent hospital, an independent clinic or an independent medical agency— in relation to England and Wales— a person who is registered under Part II of the Care Standards Act 2000 as the manager of the establishment or agency, but who is not the registered provider for that establishment or agency, or if there is no such person, but the registered provider has appointed a person to manage the establishment or agency, that appointed person, in relation to Scotland, a person, other than the registered provider, who was identified as an individual who is to manage the establishment or agency on the application for registration of that establishment or agency under Part 1 of the Regulation of Care (Scotland) Act 2001, and in relation to a nursing home, the manager of the nursing home, unless they are the registered provider for that home; . Insertion of articles 4C and 4D in the principal Order 3 After article 4B of the principal Order (exemption for health professionals who supply medicinal products under a Patient Group Direction in order to assist doctors or dentists in providing national health services) insert the following articles— Exemption for the supply of medicinal products by independent hospitals, clinics and agencies 4C 1 The restrictions imposed by sections 52 and 53 shall not apply to the supply of a medicinal product in the course of the business of— a in England, Wales or Scotland— i an independent hospital, ii an independent clinic, or iii an independent medical agency; or b in Northern Ireland, a nursing home, where the product is supplied for the purpose of being administered in accordance with a Patient Group Direction where the conditions specified in paragraph (2) are satisfied. 2 The conditions referred to are that— a the Patient Group Direction relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied, and the Direction has effect at the time at which the product is supplied; b the Patient Group Direction contains the particulars specified in Part I of Schedule 3 to this Order; c the Patient Group Direction is signed— i by or on behalf of the registered provider, and ii if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager; d the individual who supplies the product belongs to one of the classes of individual specified in Part III of Schedule 3 to this Order, and is designated in writing— i by or on behalf of the registered provider, or ii if there is a relevant manager for the independent hospital, clinic or agency, or nursing home, by that manager, for the purpose of the supply of products under the Patient Group Direction; and e at the time at which the product is supplied, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it. 3 In this article, “medicinal product” does not include a medicinal product which is a veterinary drug. Exemption for health professionals who supply medicinal products under a Patient Group Direction in order to assist the provision of health care by or on behalf of the police, the prison services or the armed forces 4D 1 The restrictions imposed by sections 52 and 53 shall not apply to the supply of a medicinal product by an individual belonging to one of the classes specified in Part III of Schedule 3 to this Order where— a that individual supplies the product in order to assist the provision of health care by, on behalf of, or under arrangements made by— i a police force in England, Wales or Scotland, ii the Police Service of Northern Ireland, iii a prison service, or iv Her Majesty’s Forces; b the product is supplied for the purpose of being administered to a particular person in accordance with a Patient Group Direction; and c the conditions specified in paragraph (2) are satisfied. 2 The conditions referred to are that— a the Patient Group Direction relates to the supply of a description or class of medicinal product in order to assist the provision of health care by, or on behalf of, or under arrangements made by the police force or service, the prison service or, as the case may be, Her Majesty’s Forces; b the Patient Group Direction has effect at the time at which the product is supplied; c the Patient Group Direction contains the particulars specified in Part I of Schedule 3 to this Order; d the Patient Group Direction is signed— i by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 3 to this Order (“the authorising person”) against the entry in column 1 of that Table for the police force or service, the prison service or Her Majesty’s Forces by whom or on whose behalf, the health care is provided, or with whom arrangements are made for the provision of such care; and ii in the case of a police force or the Police Service of Northern Ireland, by a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland; e the individual referred to in paragraph (1) is designated in writing, by or on behalf of the authorising person, for the purpose of the supply of medicinal products under the Patient Group Direction; and f at the time at which the product is supplied, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it. 3 In this article, “medicinal product” does not include a medicinal product which is a veterinary drug. . Amendment of Schedule 3 to the principal Order 4 In Schedule 3 to the principal Order , after Part II, insert the following Part— PART IIA PERSONS BY WHOM OR ON WHOSE BEHALF A PATIENT GROUP DIRECTION USED IN THE PROVISION OF HEALTH CARE BY OR ON BEHALF OF THE POLICE, THE PRISON SERVICES OR THE ARMED FORCES MUST BE SIGNED Column 1 Column 2 Force or service by whom or on whose behalf the health care is provided Person by whom or on whose behalf the Direction must be signed A police force in England and Wales The chief officer of police for that police force (within the meaning of the Police Act 1996 ) A police force in Scotland The chief constable of that police force (within the meaning of the Police (Scotland) Act 1997 ) The Police Service of Northern Ireland The Chief Constable of the Police Service of Northern Ireland The prison service in England and Wales The governor of the prison in relation to which the health care in question is being provided The prison service in Scotland The Scottish Prison Service Management Board The prison service in Northern Ireland The Northern Ireland Prison Service Management Board Her Majesty’s Forces i the Surgeon General, ii a Medical Director General, or iii a chief executive of an executive agency of the Ministry of Defence . Signed by authority of the Secretary of State for Health Hunt Parliamentary Under Secretary of State, Department of Health 13th March 2003 Sealed with the Official Seal of the Department of Health, Social Services and Public Safety D. C. Goudy Permanent Secretary Department of Health, Social Services and Public Safety 11th March 2003