The Medicines (Pharmacy and General Sale—Exemption) Amendment Order 2003

Insertion of articles 4C and 4D in the principal Order

3.  After article 4B of the principal Order(1) (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.”.

(1)

Article 4B was inserted by S.I. 2000/1919.