The Prescription Only Medicines (Human Use) Order 1997

Changes over time for: Section 12D

Version Superseded: 01/10/2010

Alternative versions:

Status:

Point in time view as at 01/09/2007. This version of this provision has been superseded.

Status

You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.

Note the term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.

Changes to legislation:

There are currently no known outstanding effects for the The Prescription Only Medicines (Human Use) Order 1997, Section 12D.

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

[F1Exemption 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 [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)

F9Words 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)(bb)

F10Words in art. 12D(2)(e) 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)(iii)