The Prescription Only Medicines (Human Use) Order 1997

[F1 Exemption for health professionals who supply or administer prescription only medicines under a Patient Group Direction in order to assist doctors or dentists in providing national health services

12B.— (1) The restrictions imposed by section 58(2) (sale, supply and administration) shall not apply to the supply or, as the case may be, the administration of a prescription only medicine by an individual belonging to one of the classes specified in Part III of Schedule 7 to this Order where—

(a) the individual supplies or, as the case may be, administers the medicine in order to assist a doctor or dentist in the provision of, respectively, NHS primary medical services or NHS primary dental services;

(b) the medicine is supplied for the purpose of being administered, or, as the case may be, is administered, 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 or, as the case may be, the administration of a description or class of prescription only medicine in order to assist the doctor or dentist in question in providing the services referred to in paragraph (1)(a) (whether or not it also relates to such supply or administration in order to assist any other doctor or dentist);

(b) the Patient Group Direction has effect at the time at which the medicine is supplied or, as the case may be, is administered;

(c) 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);

(d) the Patient Group Direction is signed—

(i) by the doctor or dentist in question or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

(ii) on behalf of the health authority [F2 or Primary Care Trust]—

(a) in the case of the provision of general medical services or general dental services, with which an arrangement has been made for the provision of those services; or

(b) in the case of the performance of personal medical services or personal dental services, which is a party to the pilot scheme under which those services are provided;

(e) the individual referred to in paragraph (1) is designated in writing for the purpose of the supply or, as the case may be, the administration of prescription only medicines under the Patient Group Direction, by the doctor or dentist in question, or, alternatively, where the Direction also relates to supply or administration in order to assist one or more other doctors or dentists, as referred to in sub-paragraph (a), by one of those other doctors or dentists; and

(f) 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.

(3) In this article—

(a) a reference to the provision of NHS primary dental services shall be construed as a reference to—

(i) in relation to England and Wales, the provision of general dental services under Part II of the National Health Service Act 1977, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997;

(ii) in relation to Scotland, the provision of general dental services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal dental services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

(iii) in relation to Northern Ireland, the provision of general dental services under the Health and Personal Social Services (Northern Ireland) Order 1972, or the performance of personal dental services in connection with a pilot scheme under the Health Services (Primary Care) (Northern Ireland) Order 1997;

(b) a reference to the provision of NHS primary medical services shall be construed as a reference to—

[F3 (i) in relation to England and Wales, the provision of primary medical services under Part I of the National Health Service Act 1977;]

(ii) in relation to Scotland, the provision of general medical services under Part II of the National Health Service (Scotland) Act 1978, or the performance of personal medical services in connection with a pilot scheme under the National Health Service (Primary Care) Act 1997; and

[F4 (iii) in relation to Northern Ireland, the provision of primary medical services under Part VI of the Health and Personal Social Services (Northern Ireland) Order 1972;]]

Textual Amendments

F1 Arts. 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)

F2 Words in art. 12B(2)(d)(ii) 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), regs. 1, 8, Sch. 5

F3 Art. 12B(3)(b)(i) substituted (E.) (1.4.2004) by The General Medical Services and Personal Medical Services Transitional and Consequential Provisions Order 2004 (S.I. 2004/865), art. 1(1), Sch. 1 para. 18(2); and substituted (W.) by The General Medical Services Transitional and Consequential Provisions (Wales) (No. 2) Order 2004 (S.I. 2004/1016), art. 1(1), Sch. 1 para. 18(2)

F4 Art. 12B(3)(b)(iii) substituted (N.I.) (1.4.2004) by The General Medical Services Transitional and Consequential Provisions (No. 2) (Northern Ireland) Order 2004 (S.R. 2004/156), art. 1(1), Sch. 1 para. 10(2) (with art. 88)