The Human Medicines Regulations 2012

Exemption for supply etc under a PGD by person conducting a retail pharmacy business U.K.

233.—(1) Regulation 214 does not apply to the sale or supply, or administration, of a prescription only medicine by a person lawfully conducting a retail pharmacy business where—

(a) the person sells, supplies or (as the case may be) administers the prescription only medicine pursuant to an arrangement for the supply or administration of prescription only medicines with—

(i) the Common Services Agency,

(ii) a health authority or special health authority,

(iii) an NHS trust,

(iv) an NHS foundation trust,

[F1 (iva) [F2 an integrated care board],

(ivb) [F3 NHS England],

(ivc) a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006),]

[F4 (ivd) Public Health England,

(ive) Public Health Agency,]

F5 (v) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(vi) a police force in England, Wales or Scotland,

(vii) the Police Service of Northern Ireland,

(viii) a prison service,

(ix) Her Majesty's Forces, or

(x) an authority or person carrying on the business of an independent hospital, an independent clinic, an independent medical agency or, in Northern Ireland, a nursing home;

(b) the prescription only medicine is sold or supplied for the purpose of being supplied or (as the case may be) is administered to a person in accordance with a patient group direction (“PGD”); and

(c) the following conditions are met.

(2) Condition A is that the PGD relates to the sale or supply or (as the case may be) administration of a description or class of medicinal product by the person lawfully conducting a retail pharmacy business who sells or supplies or (as the case may be) administers the prescription only medicine.

(3) Condition B is that the PGD has effect at the time at which the prescription only medicine is sold or supplied or (as the case may be) administered.

(4) Condition C is that the PGD contains the particulars specified in Part 1 of Schedule 16 (but with the omission of paragraph 4 in the case of a PGD relating to administration only).

(5) Condition D is that the PGD is signed—

(a) in the case of an arrangement with a body referred to in paragraph (1)(a)(i) [F6 to (ive) (health bodies), by or on behalf of the person specified in column 2 of Part 2 of Schedule 16 against the entry in column 1 for that body];

(b) in the case of an arrangement with a police force in England, Wales or Scotland or with the Police Service of Northern Ireland—

(i) by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body, and

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

(c) in the case of an arrangement with a prison service, by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body;

(d) in the case of an arrangement with Her Majesty's Forces, by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for Her Majesty's Forces;

(e) in the case of an arrangement with an authority or person referred to in paragraph (1)(a)(x) (independent hospitals etc)—

(i) by or on behalf of the registered provider, and

(ii) if there is a relevant manager for the establishment or agency in question, by that manager.

(6) Condition E is that, where the prescription only medicine is administered by the person lawfully conducting a retail pharmacy business, the person belongs to one of the classes of individual specified in Part 4 of Schedule 16 and is designated in writing for the purpose of the administration of medicinal products under the PGD—

(a) in the case of an arrangement with a body referred to in paragraph (1)(a)(i) to (v) (health bodies), on behalf of that body;

(b) in the case of an arrangement with a body referred to in paragraph (1)(a)(vi) to (ix) (a police force, the Police Service of Northern Ireland, a prison service and Her Majesty's Forces), by or on behalf of a person specified in column 2 of Part 3 of Schedule 16 against the entry in column 1 for that body; and

(c) in the case of an arrangement with an authority or person referred to in paragraph (1)(a)(x) (independent hospitals etc)—

(i) by or on behalf of the registered provider, or

(ii) if there is a relevant manager for the establishment or agency in question, by that manager.

[F7 (7) Condition F is that when the prescription only medicine is supplied or (as the case may be) administered [F8 , either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(a) in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK) [F9 or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

(b) in Great Britain, a UKMA(GB), UKMA(UK), certificate of registration, THR(GB) or THR(UK),

is in force in relation to it.]

[F10 (8) Regulation 220 does not apply to the supply, or administration, of a prescription only medicine used for vaccination or immunisation against coronavirus or influenza virus where paragraph (1)(a) and (b) applies and conditions A to F are met.

F11 (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F1 Reg. 233(1)(a)(iva)-(ivc) inserted (1.4.2013) by The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(5)(a)(i) (with Sch. 3 para. 28)

F2 Words in Regulations substituted (1.7.2022) by The Health and Care Act 2022 (Consequential and Related Amendments and Transitional Provisions) Regulations 2022 (S.I. 2022/634), reg. 1(2), Sch. para. 1(1)(3) (with Sch. para. 1(2))

F3 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1

F4 Reg. 233(1)(a)(ivd)(ive) inserted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 7(2) and reg. 233(1)(a)(ivd)(ive) inserted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 7(2)

F5 Reg. 233(1)(a)(v) omitted (1.4.2013) by virtue of The National Treatment Agency (Abolition) and the Health and Social Care Act 2012 (Consequential, Transitional and Saving Provisions) Order 2013 (S.I. 2013/235), art. 1(2), Sch. 2 para. 176(5)(a)(ii) (with Sch. 3 para. 28)

F6 Words in reg. 233(5)(a) substituted (E.W.S.) (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 7(3) and words in reg. 233(5)(a) substituted (N.I.) (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 7(3)

F7 Reg. 233(7) substituted (31.12.2020) by S.I. 2019/775, reg. 191 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 145)

F8 Words in reg. 233(7) inserted (31.12.2020 immediately after S.I. 2019/775 comes into force) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(3), 8(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(3), 8(a)

F9 Words in reg. 233(7)(a) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 20

F10 Reg. 233(8)(9) inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 8(b) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 8(b)

F11 Reg. 233(9) omitted (31.3.2022) by virtue of The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022 (S.I. 2022/350), regs. 1(2), 6