The Prescription Only Medicines (Human Use) Order 1997

[F1 Exemption for the supply and administration of prescription only medicines by independent hospitals, clinics and agencies

12D.— (1) 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 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 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 (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, 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—

(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 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 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.]

Textual Amendments

F1 Arts. 12D, 12E inserted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 11