12D.—(1) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the [F2sale or] supply or, as the case may be, the administration of a prescription only medicine in the course of the business of—
[F3(a)an independent hospital,
(b)an independent clinic,
(c)an independent medical agency, or
(d)in Northern Ireland, a nursing home,]
where the medicine is [F4sold or] 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 (2) are satisfied.
(2) The conditions referred to are that—
(a)the Patient Group Direction relates to the [F5sale or] supply or, as the case may be, the administration, by the person who [F6sells or] 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 [F7sold or] 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—
(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 [F8sells or] 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—
(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 [F9sale or] 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 [F10sold or] 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.]
Textual Amendments
F1Arts. 12D, 12E inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 11
F2Words in art. 12D(1) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(a)(i)
F3Art. 12D(1)(a)-(d) substituted for art. 12D(1)(a)(b) (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(a)(ii)
F4Words in art. 12D(1) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(a)(iii)
F5Words in art. 12D(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(i)(aa)
F6Words in art. 12D(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(i)(bb)
F7Words in art. 12D(2)(a) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(i)(cc)
F8Words in art. 12D(2)(d) inserted (1.9.2007) by The Medicines for Human Use (Administration and Sale or Supply) (Miscellaneous Amendments) Order 2007 (S.I. 2007/2178), arts. 1(1), 4(b)(ii)(aa)