The Prescription Only Medicines (Human Use) Order 1997

[F1 Exemption for persons conducting a retail pharmacy business who supply or administer prescription only medicines under a Patient Group Direction

12C.— (1) The restrictions imposed by section 58(2) (restrictions on sale, supply and administration) shall not apply to the [F2 sale or] supply or, as the case may be, the administration of a prescription only medicine by a person lawfully conducting a retail pharmacy business within the meaning of section 69 where—

[F3 (a) the medicine—

(i) is supplied, or as the case may be, is administered by such a person pursuant to an arrangement made with—

(aa) a body referred to in article 12A(a) to (d),

(bb) a force or service referred to in article 12E(1)(a)(i) to (iii), or

(cc) Her Majesty’s Forces,

for the supply or, as the case may be, the administration of prescription only medicines; or

(ii) is sold or supplied or, as the case may be, is administered by such a person pursuant to an arrangement made with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1) for the sale or supply or, as the case may be, the administration of prescription only medicines;]

(b) the medicine is [F4 sold 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

(c) the conditions specified in paragraph (2) are satisfied.

(2) The conditions referred to are that—

(a) the Patient Group Direction relates to the [F5 sale or] supply or, as the case may be, the administration of a description or class of prescription only medicine by the person lawfully conducting a retail pharmacy business who [F6 sells or] supplies or, as the case may be, administers the prescription only medicine, and the Direction has effect at the time at which the medicine is [F7 sold 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);

[F8 (c) the Patient Group Direction is signed—

(i) in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body,

(ii) in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider and, if there is a relevant manager for the establishment or agency, that manager,

(iii) in the case of an arrangement with a prison service, by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that service,

(iv) in the case of an arrangement with a police force or the Police Service of Northern Ireland—

(a) by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, and

(b) a doctor who is not employed or engaged by, and who does not provide services under arrangements made with, any police force or the Police Service of Northern Ireland, and

(v) in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces;]

[F9 (cc) where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business within the meaning of section 69, the individual who administers the medicine belongs to one of the classes of individual specified in Part III of Schedule 7 to this Order, and is [F10 designated in writing—

(i) in the case of an arrangement with a body referred to in article 12A(a) to (d), on behalf of that body,

(ii) in the case of an arrangement with an authority or person carrying on the business of an establishment or agency referred to in article 12D(1), by or on behalf of the relevant provider or, if there is a relevant manager for the establishment or agency, that relevant manager,

(iii) in the case of an arrangement with a force or service referred to in article 12E(1)(a)(i) to (iii), by or on behalf of the person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for that force or service, or

(iv) in the case of an arrangement with Her Majesty’s Forces, by or on behalf of a person specified in column 2 of the Table in Part IIA of Schedule 7 to this Order against the entry in column 1 of that Table for Her Majesty’s Forces,

for the purpose of the administration of prescription only medicines under the Patient Group Direction; and]]

(d) at the time at which the medicine is [F11 sold 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

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. 12C(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), 3(a)(i)

F3 Art. 12C(1)(a) substituted (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), 3(a)(ii)

F4 Words in art. 12C(1)(b) 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), 3(a)(iii)

F5 Words in art. 12C(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), 3(b)(i)(aa)

F6 Words in art. 12C(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), 3(b)(i)(bb)

F7 Words in art. 12C(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), 3(b)(i)(cc)

F8 Art. 12C(2)(c) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 10(b)(i)

F9 Art. 12C(2)(cc) inserted (16.11.2000) by The Prescription Only Medicines (Human Use) Amendment (No. 2) Order 2000 (S.I. 2000/2899), arts. 1(1), 3(1)

F10 Words in art. 12C(2)(cc) substituted (4.4.2003) by The Prescription Only Medicines (Human Use) Amendment Order 2003 (S.I. 2003/696), arts. 1(1), 10(b)(ii)

F11 Words in art. 12C(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), 3(b)(ii)