12A.—(1) The restrictions imposed by section 58(2)(a) (restrictions on sale and supply) shall not apply to the supply of a prescription only medicine by—
(a)the Common Services Agency;
(b)a [F2Strategic Health Authority,] Health Authority or Special Health Authority;
(c)an NHS trust [F3or NHS foundation trust];
(d)a Primary Care Trust; or
(e)where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply of prescription only medicines,
where the medicine is supplied for the purpose of being administered to a particular person in accordance with the written directions of a doctor or dentist relating to that person notwithstanding that those directions do not satisfy the conditions specified in article 15(2).
(2) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by—
(a)the Common Services Agency;
(b)a [F4Strategic Health Authority,] Health Authority or Special Health Authority;
(c)an NHS trust [F5or NHS foundation trust];
(d)a Primary Care Trust; or
(e)where sub-paragraphs (a) to (d) do not apply, a person other than an excepted person, pursuant to an arrangement made with one of the persons specified in those sub-paragraphs for the supply or, as the case may be, the administration of prescription only medicines,
where the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, to a particular person in accordance with a Patient Group Direction and where the conditions specified in paragraph (3) are satisfied.
(3) The conditions referred to are that—
(a)the Patient Group Direction relates to the supply or, as the case may be, the administration, by the person who supplies or administers the medicine, of a description or class of prescription only medicine, and the Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;
(b)the Patient Group Direction contains the particulars specified in Part I of Schedule 7 to this Order (but with the omission of paragraph (c) of that Part in the case of a Direction which relates to administration only);
(c)the Patient Group Direction is signed on behalf of the person specified in column 2 of the Table in Part II of Schedule 7 to this Order (“the authorising person”) against the entry in column 1 of that Table for the class of person by whom the medicine is supplied or administered;
(d)the individual who supplies or, as the case may be, administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is designated in writing, on behalf of the authorising person, for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction; and
(e)at the time at which the medicine is supplied or, as the case may be, is administered, a product licence, a marketing authorization or a homoeopathic certificate of registration has effect in respect of it.
(4) In this article, “excepted person” means—
(a)a doctor or dentist; or
(b)a person lawfully conducting a retail pharmacy business within the meaning of section 69.]
Textual Amendments
F1Arts. 12A-12C inserted (9.8.2000) by The Prescription Only Medicines (Human Use) Amendment Order 2000 (S.I. 2000/1917), arts. 1(1), 2(d)
F2Words in art. 12A(1)(b) inserted (1.10.2002) by The National Health Service Reform and Health Care Professions Act 2002 (Supplementary, Consequential etc. Provisions) Regulations 2002 (S.I. 2002/2469), reg. 1, Sch. 1 para. 73(2)(a)
F3Words in art. 12A(1)(c) inserted (1.4.2004) by The Health and Social Care (Community Health and Standards) Act 2003 (Supplementary and Consequential Provision) (NHS Foundation Trusts) Order 2004 (S.I. 2004/696), arts. 1(1)(b), 3(2), Sch. 2