The Human Medicines Regulations 2012

Changes over time for: Section 229

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Exemption for supply by national health service bodies [F1and local authorities] U.K.

This section has no associated Explanatory Memorandum

229.—(1) Regulations 214(1) [F2and (2)], 220 and 221 do not apply to the supply of a medicinal product in accordance with condition A or B by—

(a)the Common Services Agency;

(b)a health authority or special health authority;

(c)an NHS trust;

(d)an NHS foundation trust;

[F3(da)a local authority in the exercise of public health functions (within the meaning of the National Health Service Act 2006); F4...]

[F5(db)Public Health England;

(dc)Public Health Agency; or]

F6(e). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(f)a person who is not a doctor, dentist or person lawfully conducting a retail pharmacy business, where the person supplies the product pursuant to an arrangement with [F7[F8an integrated care board], [F9NHS England] or] one of the persons specified in paragraphs (a) [F10to [F11(dc)]].

(2) Condition A is that the product is supplied for the purpose of being administered to a person in accordance with the written directions of a doctor, dentist, nurse independent prescriber, optometrist independent prescriber [F12, physiotherapist independent prescriber, podiatrist independent prescriber, therapeutic radiographer independent prescriber] [F13, paramedic independent prescriber] or pharmacist independent prescriber relating to that person, regardless of whether the directions comply with regulation 217 (requirements for prescriptions).

[F14(2A) In relation to a medicinal product that is for parenteral administration, condition A only applies if the person who has given the written directions is an appropriate practitioner in relation to that medicinal product.]

(3) Condition B is that—

(a)the product is supplied for the purpose of being administered to a person in accordance with a patient group direction (“PGD”);

(b)the PGD relates to the supply of a description or class of medicinal product by the person by whom the medicinal product is supplied and has effect at the time at which it is supplied;

(c)the PGD contains the particulars specified in Part 1 of Schedule 16;

(d)the PGD is signed on behalf of the person specified in column 2 of the table in Part 2 of that Schedule (“the authorising person”) against the entry in column 1 of that table for the class of person by whom the product is supplied;

(e)the individual who supplies the product—

(i)belongs to one of the classes of individual specified in Part 4 of that Schedule, and

(ii)is designated in writing, on behalf of the authorising person, for the purpose of the supply or administration of products under the PGD; and

[F15(f)when the product is supplied [F16, either an authorisation by the licensing authority on a temporary basis under regulation 174 or]—

(i)in Northern Ireland, a UKMA(NI), UKMA(UK), EU marketing authorisation, Article 126a authorisation, certificate of registration, THR(NI) or THR(UK), [F17or, in the case of a listed NIMAR product, a UKMA(UK) or UKMA(GB),] or

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

is in force in relation to it.]

F18(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1Words in reg. 229 heading 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(3)(a) (with Sch. 3 para. 28)

F2Words in reg. 229(1) inserted (19.12.2020) by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.I. 2020/1594), regs. 1(2), 5(a) and The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 (S.R. 2020/350), regs. 1(2), 5(a)

F3Reg. 229(1)(da) 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(3)(b) (with Sch. 3 para. 28)

F4Word in reg. 229(1)(da) omitted (E.W.S.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(a) and word in reg. 229(1)(da) omitted (N.I.) (1.4.2015) by virtue of The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(a)

F5Reg. 229(1)(db)(dc) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 4(2)(b) and reg. 229(1)(db)(dc) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 4(2)(b)

F6Reg. 229(1)(e) 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(3)(c) (with Sch. 3 para. 28)

F7Words in reg. 229(1)(f) 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(3)(d)(i) (with Sch. 3 para. 28)

F8Words 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))