OpenLegislation

Regulation 346 ReviewF1

United Kingdom

Changes not yet applied. Later legislation changes this provision in ways not yet written into the text below:

(1)

The Secretary of State must from time to time carry out a review of the provisions listed in paragraph (2).

(2)

Those provisions are—

(a)

Chapters 1, 3 and 4 of Part 3;

(b)

Parts 11 and 12A;

(c)

regulations—

(F2ai)

17A,

(bi)

17B,

(i)

F318(6),

(ii)

20(1),

(F4iiza)

27A,

(iizb)

29A,

(iizc)

29B

F5(iia)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iii)

37(4)(b), (5), (6), (11) and (12),

(F6iiiza)

37A,

(iiizb)

37B,

F7(iiia)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(iv)

43(5), (6)(a) F8and (d), 7(c)(iii) and (vii), (8) and F9(12) to (14),

F10(iva)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(v)

44(1) to (6),

(F11va)

50K,

(vi)

59,

(vii)

60(3)(b), (9) and (10),

(viii)

61,

(ix)

63,

(x)

64(4)(b), (d) and (e), (5)(a) and (6)(c),

(xi)

65(2),

(xii)

66(5) and (6),

(xiii)

68(2)(a) and (b), (5) and (12A),

(xiv)

69(2)(a) and (b), (5) and (10),

(F12xiva)

73(5A) to (5C),

(F13xivb)

74A,

(xivc)

74B,

(xv)

75(2)(b) and (c),

(xvi)

76,

(xvii)

79,

F14(xviia)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15(xviii)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16(xix)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17(xixa)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xx)

97,

(xxi)

105(3)(b),

(xxii)

107(2),

(xxiii)

108(5),

(xxiv)

110(8A),

(F18xxiva)

113(3A),

(xxv)

115(2)(b) and (c),

(xxvi)

132(2),

(xxvii)

133(5) and (6),

(xxviii)

135(10A),

(F19xxviiia)

142(5A) to (5C),

(F20xxviiiaza)

regulations 167A F21to 167H,

(F22xxviiiazb)

170A,

(xxviiiazc)

170B,

(F23xxviiiaa)

regulation 174A,

(F24xxviiib)

213(3),

(F25xxviiiba)

214(5C) F26and (5D),

(xxviiic)

217A,

(xxviiid)

218(2)(b) and (c), (3) and (5),

(F27xxviiie)

219 and 219A,

(F28xxviiiezb)

220B,

(F29xxviiiea)

223(3)(b),

(F30xxviiieb)

226A,

(F31xxviiieb)

228(2)(d)(iv),

(F32xxviiif)

229(1)(db) and (dc) F33and (2),

(F34xxviiifa)

233(1)(a)(ivd) and (ive),

(xxviiig)

234(2)(e),

(F35xxviiiga)

F36regulation 235A,

(F37xxviiih)

248(1)(a) and (2)(a),

F38(xxviiii)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F39(xxviiij)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(F40xxviiik)

257CA,

(xxix)

266(4) and (5),

(xxx)

327(2)(g) and insofar as the provision relates to active substances paragraphs (1)(c)(iii), (iv) and (viii), (2)(a) to (f), (3), (4) and (6),

(xxxi)

330(1) and (2),

(xxxii)

331, and

(xxxiii)

regulation 349 insofar as it repeals section 10(7) of the Medicines Act 1968; and

(d)

Schedules—

(i)

5 paragraphs 1(1)(b) to (d), (2)(b) to (d), 3(11)(b)(vi) to (viii), 5(2)(f) to (h),

F41(ia)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii)

7A,

(iii)

8 paragraphs 9A, 12, 13, 19 and 23,

(iv)

12 paragraph 21,

(F42ivza)

16, Part 2 entries relating to F43“the United Kingdom Health Security Agency” and “Public Health Agency” and Part 3 entries relating to “search and rescue operations”,

(iva)

17, Part 1 items 12 and 13, Part 2 items F44... 11 and 12, F45Part 3 item 11, Part 4 items 11 to 13 and Part 5 items ... 18 F46to 20,

(ivaa)

23, paragraph 1(a)(vii) to F47(x),

(F48ivab)

24 paragraph 18A,

(F49ivb)

22, entries relating to F50“the United Kingdom Health Security Agency”, “Public Health Agency” and “search and rescue operations”, and

(v)

27 paragraphs 14 and 15.

(3)

The Secretary of State must—

(a)

set out the conclusions of a review carried out in accordance with paragraph (1) in a report; and

(b)

publish the report.

(F514)

In carrying out the review the Secretary of State must, so far as is reasonable, have regard to how—

(a)

the 2001 Directive;

(b)

Directive 2010/84/EU of the European Parliament and of the Council of 15 October 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use;

(c)

Article 11 of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare;

(d)

Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products; and

(e)

Commission Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State,

are implemented in other member States in relation to the subject matter of the provisions mentioned in paragraph (2).

(5)

The report must in particular—

(a)

set out the objectives intended to be achieved by the regulatory system established by the provisions of these Regulations that implement those Directives in relation to the subject matter of the provisions mentioned in paragraph (2)(a), (b), (c)(i) to F52(xxxii) and (d);

(b)

assess the extent to which those objectives are achieved; and

(c)

assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(6)

The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(7)

Reports under this regulation are afterwards to be published at intervals not exceeding five years.

Annotations

Textual amendments

F1

Reg. 346 substituted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 31

F2

Reg. 346(2)(c)(ai)(bi) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(a)

F3

Word in reg. 346(2)(c)(i) substituted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(i) and word in reg. 346(2)(c)(i) substituted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(i)

F4

Reg. 346(2)(c)(iiza)-(iizc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(b)

F5

Reg. 346(2)(c)(iia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F6

Reg. 346(2)(c)(iiiza)(iiizb) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(c)

F7

Reg. 346(2)(c)(iiia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F8

Words in reg. 346(2)(c)(iv) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(ii) and words in reg. 346(2)(c)(iv) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(ii)

F9

Word in reg. 346(2)(c)(iv) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(a)

F10

Reg. 346(2)(c)(iva) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F11

Reg. 346(2)(c)(va) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(d)

F12

Reg. 346(2)(b)(xiva) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8

F13

Reg. 346(2)(c)(xivb)(xivc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(e)

F14

Reg. 346(2)(c)(xviia) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F15

Reg. 346(2)(c)(xviii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F16

Reg. 346(2)(c)(xix) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F17

Reg. 346(2)(c)(xixa) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 227(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 187(a)); 2020 c. 1, Sch. 5 para. 1(1)

F18

Reg. 346(2)(b)(xxiva) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8

F19

Reg. 346(2)(b)(xxviiia) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8

F20

Reg. 346(2)(c)(xxviiiaza) inserted (1.1.2022) by The Human Medicines (Amendment) (Supply to Northern Ireland) Regulations 2021 (S.I. 2021/1452), regs. 1(2), 23

F21

Words in reg. 346(2)(c)(xxviiiaza) substituted (15.4.2022) by The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 (S.I. 2022/352), regs. 1(2), 11 (with reg. 19)

F22

Reg. 346(2)(c)(xxviiiazb)(xxviiiazc) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(f)

F23

Reg. 346(2)(c)(xxviiiaa) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 30(a) and reg. 346(2)(c)(xxviiiaa) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 30(a)

F24

Reg. 346(2)(c)(xxviiib)-(xxviiie) inserted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(2)(a) and reg. 346(2)(c)(xxviiib)-(xxviiie) inserted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(2)(a)

F25

Reg. 346(2)(c)(xxviiiba) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(iii) and reg. 346(2)(c)(xxviiiba) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(iii)

F26

Words in reg. 346(2)(c)(xxviiiba) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(a)(i) and words in reg. 346(2)(c)(xxviiiba) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(a)(i)

F27

Reg. 346(2)(c)(xxviiie) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 8 and reg. 346(2)(c)(xxviiie) substituted (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 8

F28

Reg. 346(2)(c)(xxviiiezb) inserted (7.1.2026) by The Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 (S.I. 2025/1249), arts. 1(2)(5)(c), 12(16)(b)

F29

Reg. 346(2)(c)(xxviiiea) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(iv) and reg. 346(2)(c)(xxviiiea) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(iv)

F30

Reg. 346(2)(c)(xxviiieb) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(v) and reg. 346(2)(c)(xxviiieb) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(v)

F31

Reg. 346(2)(c)(xxviiieb) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(a)(ii) and reg. 346(2)(c)(xxviiieb) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(a)(ii)

F32

Reg. 346(2)(c)(xxviiif)(xxviiig) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(a) and reg. 346(2)(c)(xxviiif)(xxviiig) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(a)

F33

Words in reg. 346(2)(c)(xxviiif) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(v) and words in reg. 346(2)(c)(xxviiif) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(v)

F34

Reg. 346(2)(c)(xxviiifa) inserted (1.10.2015) by The Human Medicines (Amendment) (No. 3) Regulations 2015 (S.I. 2015/1503), regs. 1, 9(2)(a) and reg. 346(2)(c)(xxviiifa) inserted (1.10.2015) by The Human Medicines (Amendment) (No.3) Regulations 2015 (S.R. 2015/354), regs. 1, 9(2)(a)

F35

Reg. 346(2)(c)(xxviiiga) inserted (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.I. 2020/1125), regs. 1(2), 30(b) and reg. 346(2)(c)(xxviiiga) inserted (N.I.) (6.11.2020) by The Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 (S.R. 2020/349), regs. 1(2), 30(b)

F36

Words in reg. 346(2)(c)(xxviiiga) substituted (31.3.2026) by The Human Medicines (Amendment) Regulations 2026 (S.I. 2026/381), regs. 1(2), 12

F37

Reg. 346(2)(c)(xxviiih) inserted (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(a)(vi) and reg. 346(2)(c)(xxviiih) inserted (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(a)(vi)

F38

Reg. 346(2)(c)(xxviiii) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F39

Reg. 346(2)(c)(xxviiij) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 132(b)

F40

Reg. 346(2)(c)(xxviiik) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 33(2)(g)

F41

Reg. 346(2)(d)(ia) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 227(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 187(b)); 2020 c. 1, Sch. 5 para. 1(1)

F42

Reg. 346(2)(d)(ivza) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(b)(i) and reg. 346(2)(d)(ivza) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(b)(i)

F43

Words in reg. 346(2)(d)(ivza) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(a)

F44

Words in reg. 346(2)(d)(iva) omitted (2.12.2024) by virtue of The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(b)

F45

Words in reg. 346(2)(d)(iva) inserted (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.I. 2017/715), regs. 1, 7 and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.10.2017) by The Human Medicines (Amendment) Regulations 2017 (S.R. 2017/241), regs. 1, 7

F46

Words in reg. 346(2)(d)(iva) inserted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(i) and words in reg. 346(2)(d)(iva) inserted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(i)

F47

Word in reg. 346(2)(d)(ivaa) substituted (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.I. 2018/199), regs. 1, 11(2)(b)(ii) and word in reg. 346(2)(d)(ivaa) substituted (N.I.) (1.4.2018) by The Human Medicines (Amendment) Regulations 2018 (S.R. 2018/64), regs. 1, 11(2)(b)(ii)

F48

Reg. 346(2)(d)(ivab) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(b)(ii) and reg. 346(2)(d)(ivab) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(b)(ii)

F49

Reg. 346(2)(d)(ivb) inserted (E.W.S.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.I. 2015/323), regs. 1, 6(2)(b)(iii) and reg. 346(2)(d)(ivb) inserted (N.I.) (1.4.2015) by The Human Medicines (Amendment) Regulations 2015 (S.R. 2015/178), regs. 1, 6(2)(b)(iii)

F50

Words in reg. 346(2)(d)(ivb) substituted (2.12.2024) by The Human Medicines (Amendments Relating to Naloxone and Transfers of Functions) Regulations 2024 (S.I. 2024/1125), regs. 1(2), 9(c)

F51

Reg. 346(4) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(3) and reg. 346(4) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(3)

F52

Word in reg. 346(5)(a) substituted (E.W.S.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.I. 2014/490), regs. 1(2), 9(4) and word in reg. 346(5)(a) substituted (N.I.) (31.3.2014) by The Human Medicines (Amendment) Regulations 2014 (S.R. 2014/323), regs. 1(2), 9(4)