The Human Medicines Regulations 2012 No. 1916

PART 17 U.K. Miscellaneous and general

Review U.K.

[F1 Review U.K.

346.— (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—

(i) [F2 18(6)],

(ii) 20(1),

[F3 (iia) 36(4) to (7),]

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

[F4 (iiia) 42(4) and (5),]

(iv) 43(5), (6)(a) [F5 and (d)], 7(c)(iii) and (vii), (8) and (10) to (14),

[F6 (iva) 43A,]

(v) 44(1) to (6),

(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),

[F7 (xiva) 73(5A) to (5C),]

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

(xvi) 76,

(xvii) 79,

[F8 (xviia) 82(1)(c),]

(xviii) 85,

(xix) 86,

F9 (xixa) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(xx) 97,

(xxi) 105(3)(b),

(xxii) 107(2),

(xxiii) 108(5),

(xxiv) 110(8A),

[F10 (xxiva) 113(3A),]

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

(xxvi) 132(2),

(xxvii) 133(5) and (6),

(xxviii) 135(10A),

[F11 (xxviiia) 142(5A) to (5C),]

[F12 (xxviiiaza) regulations 167A [F13 to 167H],]

[F14 (xxviiiaa) regulation 174A,]

[F15 (xxviiib) 213(3),]

[F16 (xxviiiba) 214(5C) [F17 and (5D)],]

[F15 (xxviiic) 217A,]

[F15 (xxviiid) 218(2)(b) and (c), (3) and (5),]

[F18 (xxviiie) 219 and 219A,]

[F19 (xxviiiea) 223(3)(b),]

[F20 (xxviiieb) 226A,]

[F21 (xxviiieb) 228(2)(d)(iv),]

[F22 (xxviiif) 229(1)(db) and (dc) [F23 and (2)],

[F24 (xxviiifa) 233(1)(a)(ivd) and (ive),]

(xxviiig) 234(2)(e),]

[F25 (xxviiiga) regulation 247A,]

[F26 (xxviiih) 248(1)(a) and (2)(a),]

[F27 (xxviiii) 255A to 255C,

(xxviiij) 257A,]

(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),

F28 (ia) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(ii) 7A,

(iii) 8 paragraphs 9A, 12, 13, 19 and 23,

(iv) 12 paragraph 21,

[F29 (ivza) 16, Part 2 entries relating to “Public Health England” and “Public Health Agency” and Part 3 entries relating to “search and rescue operations”,]

[F30 (iva) 17, Part 1 items 12 and 13, Part 2 items 4a, 11 and 12, [F31 Part 3 item 11,] Part 4 items 11 to 13 and Part 5 items 7a and 18 [F32 to 20],

(ivaa) 23, paragraph 1(a)(vii) to [F33 (x)],]

[F34 (ivab) 24 paragraph 18A,]

[F35 (ivb) 22, entries relating to “Public Health England”, “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.

[F36 (4) 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 [F37 (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.]

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 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)

F3 Reg. 346(2)(c)(iia) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(i) and reg. 346(2)(c)(iia) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(i)

F4 Reg. 346(2)(c)(iiia) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(ii) and reg. 346(2)(c)(iiia) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(ii)

F5 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)

F6 Reg. 346(2)(c)(iva) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(iii) and reg. 346(2)(c)(iva) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(iii)

F7 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

F8 Reg. 346(2)(b)(xviia) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 8

F9 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)

F10 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

F11 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

F12 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

F13 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)

F14 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)

F15 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)

F16 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)

F17 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)

F18 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

F19 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)

F20 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)

F21 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)

F22 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)

F23 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)

F24 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)

F25 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)

F26 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)

F27 Reg. 346(2)(c)(xxviiii)(xxviiij) inserted (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.I. 2019/62), regs. 1, 16(a)(vi) and reg. 346(2)(c)(xxviiii)(xxviiij) inserted (N.I.) (9.2.2019) by The Human Medicines (Amendment) Regulations 2019 (S.R. 2019/10), regs. 1, 16(a)(vi)

F28 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)

F29 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)

F30 Reg. 346(2)(d)(iva)(ivaa) substituted for reg. 346(2)(d)(iva) (E.W.S.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.I. 2016/186), regs. 1, 15(2)(b)(i) and reg. 346(2)(d)(iva)(ivaa) substituted for reg. 346(2)(d)(iva) (N.I.) (1.4.2016) by The Human Medicines (Amendment) Regulations 2016 (S.R. 2016/407), regs. 1, 15(2)(b)(i)

F31 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

F32 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)

F33 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)

F34 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)

F35 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)

F36 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)

F37 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)