The Human Medicines Regulations 2012

Changes over time for: Section 229

Alternative versions:

Changes to legislation:

The Human Medicines Regulations 2012, Section 229 is up to date with all changes known to be in force on or before 05 November 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.

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Changes and effects yet to be applied to Regulation 229:

reg. 229(3)(f) words substituted by S.I. 2019/775 reg. 187 (This amendment not applied to legislation.gov.uk. Reg. 187 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 141)
reg. 229(3)(f)(i) words omitted by S.I. 2024/832 reg. 101

Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:

Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):

Sch. 11 para. 1(1)(d)-(f) inserted by S.I. 2019/775 reg. 63(2)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 63(2)(a)(ii) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(2))
Sch. 24 para. 18B inserted by S.I. 2024/832 reg. 142(e)
Sch. 24 Pt. 1 para. 23 words omitted by S.I. 2024/832 reg. 142(f)
Sch. 33A para. 57A inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(4) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
Sch. 33A para. 57(3) substituted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
Sch. 33A para. 57(2) words inserted by S.I. 2019/775, Sch. 7 (as amended) by S.I. 2019/1385 Sch. 1 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 10(3)(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(c))
Sch. 33B inserted by S.I. 2024/832 reg. 146
reg. 3(12)(d)(ia) omitted by S.I. 2024/832 reg. 4(a)
reg. 4(4)(d)(ia) omitted by S.I. 2024/832 reg. 5
reg. 43(7)(b)(ii)(bb) words omitted by S.I. 2024/832 reg. 18(b)
reg. 49(1ZA)-(1ZD) inserted by S.I. 2024/832 reg. 26(a)
reg. 49(3ZA) inserted by S.I. 2024/832 reg. 26(d)
reg. 51(9) words inserted by S.I. 2019/775, reg. 56 (as amended) by S.I. 2019/1385 Sch. 1 para. 5 (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
reg. 52(1)(a)(i)(ii) and words substituted by S.I. 2019/775 reg. 57(2) (This amendment not applied to legislation.gov.uk. Reg. 57 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 42)
reg. 53(2)-(2C) substituted for reg. 53(2) by S.I. 2019/775 reg. 58(3) (This amendment not applied to legislation.gov.uk. Reg. 58 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 43)
reg. 53(2)(a) substituted by S.I. 2019/775, reg. 58(3) (as amended) by S.I. 2019/1385 Sch. 1 para. 6(2) (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
reg. 55(1)(b)(iii)(bb) substituted by S.I. 2024/832 reg. 43(a)(ii)
reg. 60A(10A) inserted by S.I. 2024/832 reg. 49(e)
reg. 68(11H)-(A12) inserted by S.I. 2024/832 reg. 56(b)
reg. 173(e) inserted by S.I. 2017/1322 Sch. 4 para. 2(2)(b) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(i).)
reg. 240(2A) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(c) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
reg. 240(6A) inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(g) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
reg. 257(9) inserted by S.I. 2024/832 reg. 110(c)
reg. 257AA 257AB inserted by S.I. 2024/832 reg. 111
reg. 327(1)(c)(va) omitted by S.I. 2024/832 reg. 128(a)
reg. 346(2)(c)(iia) omitted by S.I. 2024/832 reg. 132(b)
reg. 346(2)(c)(iiia) omitted by S.I. 2024/832 reg. 132(b)
reg. 346(2)(c)(iva) omitted by S.I. 2024/832 reg. 132(b)
reg. 346(2)(c)(xviia) omitted by S.I. 2024/832 reg. 132(b)
reg. 346(2)(c)(xxviiij) omitted by S.I. 2024/832 reg. 132(b)
reg. 347B inserted by S.I. 2024/832 reg. 133

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))