Changes to legislation:
The Human Medicines Regulations 2012 is up to date with all changes known to be in force on or before 31 July 2024. There are changes that may be brought into force at a future date.![Help about Changes to Legislation](/images/chrome/helpIcon.gif)
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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 affected provisions when you open the content using the Table of Contents below.
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Changes and effects yet to be applied to
:
- reg. 38 heading words substituted by S.I. 2019/775 reg. 29(2) (This amendment not applied to legislation.gov.uk. Reg. 29(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(a))
- reg. 149 heading word inserted by S.I. 2019/775 reg. 131(2) (This amendment not applied to legislation.gov.uk. Reg. 131 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 98)
- Pt. 8 omitted by S.I. 2019/775 reg. 132 (This amendment not applied to legislation.gov.uk. Reg. 132 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 99)
- reg. 210A heading words substituted by S.I. 2019/775 reg. 175(2) (This amendment not applied to legislation.gov.uk. Reg. 175(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 137(a))
- reg. 196 and cross-heading substituted by S.I. 2019/775 reg. 156 (This amendment not applied to legislation.gov.uk. Reg. 156 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 124)
- Pt. 12A omitted by S.I. 2019/775 reg. 197 (This amendment not applied to legislation.gov.uk. Reg. 197 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 151)
- Sch. 1 word inserted by S.I. 2019/775 reg. 8 (This amendment not applied to legislation.gov.uk. Reg. 8 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 5)
- Sch. 3 para. 3(3)(b)(iv) omitted by S.I. 2019/775 reg. 18(4)(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 18(4)(b)(ii) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 12(c)(ii))
- Sch. 3 para. 3(3)(b)(i) word inserted by S.I. 2019/775 reg. 18(4)(b)(i) (This amendment not applied to legislation.gov.uk. Reg. 18(4)(b)(i) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 12(c)(i))
- Sch. 3 para. 1(2)(g) words substituted by S.I. 2019/775 reg. 18(2) (This amendment not applied to legislation.gov.uk. Reg. 18(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 12(a))
- Sch. 3 para. 2(1) words substituted by S.I. 2019/775 reg. 18(3) (This amendment not applied to legislation.gov.uk. Reg. 18(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 12(b))
- Sch. 4 para. 13(b) words substituted by S.I. 2019/775 reg. 20(2) (This amendment not applied to legislation.gov.uk. Reg. 20(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 14(a))
- Sch. 4 para. 15 words substituted by S.I. 2019/775 reg. 20(4) (This amendment not applied to legislation.gov.uk. Reg. 20(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 14(d))
- Sch. 4 para. 22(1) words substituted by S.I. 2019/775 reg. 20(4) (This amendment not applied to legislation.gov.uk. Reg. 20(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 14(d))
- Sch. 4 para. 23 words substituted by S.I. 2019/775 reg. 20(4) (This amendment not applied to legislation.gov.uk. Reg. 20(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 14(d))
- Sch. 4 para. 33 words substituted by S.I. 2019/775 reg. 20(6) (This amendment not applied to legislation.gov.uk. Reg. 20(6) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 14(e))
- Sch. 4 Pt. 2 heading words substituted by S.I. 2019/775 reg. 20(3) (This amendment not applied to legislation.gov.uk. Reg. 20(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 14(c))
- Sch. 7 para. 13 omitted by S.I. 2019/775 reg. 32(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 32(3)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 22(e))
- Sch. 7 para. 14(1)(a) words substituted by S.I. 2019/775 reg. 32(3)(c)(i) (This amendment not applied to legislation.gov.uk. Reg. 32(3)(c)(i) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 22(f)(i))
- Sch. 7 para. 14(1)(b) words substituted by S.I. 2019/775 reg. 32(3)(c)(ii)(aa) (This amendment not applied to legislation.gov.uk. Reg. 32(3)(c)(ii) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 22(f)(ii))
- Sch. 7 para. 14(1)(b) words substituted by S.I. 2019/775 reg. 32(3)(c)(ii)(bb) (This amendment not applied to legislation.gov.uk. Reg. 32(3)(c)(ii) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 22(f)(ii))
- Sch. 7 para. 14(1)(b)(i) words substituted by S.I. 2019/775 reg. 32(3)(c)(ii)(cc) (This amendment not applied to legislation.gov.uk. Reg. 32(3)(c)(ii) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 22(f)(ii))
- Sch. 8 para. 12(b) omitted by S.I. 2019/775 reg. 50(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 50(2)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(a)(ii))
- Sch. 8 para. 20 omitted by S.I. 2019/775 reg. 50(5) (This amendment not applied to legislation.gov.uk. Reg. 50(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(d))
- Sch. 8 para. 22 omitted by S.I. 2019/775 reg. 50(7) (This amendment not applied to legislation.gov.uk. Reg. 50(7) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(f))
- Sch. 8 para. 23 word inserted by S.I. 2019/775 reg. 50(8)(c) (This amendment not applied to legislation.gov.uk. Reg. 50(8) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(g))
- Sch. 8 para. 12(e) words inserted by S.I. 2019/775 reg. 50(2)(c) (This amendment not applied to legislation.gov.uk. Reg. 50(2)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(a)(iii))
- Sch. 8 para. 23 words inserted by S.I. 2019/775 reg. 50(8)(b) (This amendment not applied to legislation.gov.uk. Reg. 50(8) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(g))
- Sch. 8 para. 19 words substituted by S.I. 2019/775 reg. 50(4) (This amendment not applied to legislation.gov.uk. Reg. 50(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(c))
- Sch. 8 para. 21 words substituted by S.I. 2019/775 reg. 50(6) (This amendment not applied to legislation.gov.uk. Reg. 50(6) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(e))
- Sch. 8 para. 23 words substituted by S.I. 2019/775 reg. 50(8)(a) (This amendment not applied to legislation.gov.uk. Reg. 50(8) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 38(g))
- Sch. 11 para. 1(2) omitted by S.I. 2019/775 reg. 63(2)(c) (This amendment not applied to legislation.gov.uk. Reg. 63(2)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 46(a))
- Sch. 11 para. 17 omitted by S.I. 2019/775 reg. 63(7) (This amendment not applied to legislation.gov.uk. Reg. 63(7) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 46(c))
- Sch. 11 para. 24(2) omitted by S.I. 2019/775 reg. 63(8)(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 63(8)(b)(ii) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 46(d))
- Sch. 11 Pt. 4 omitted by S.I. 2019/775 reg. 63(9) (This amendment not applied to legislation.gov.uk. Reg. 63(9) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 46(e))
- Sch. 11 para. 12(1) word inserted by S.I. 2019/775 reg. 63(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 63(3) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(4))
- Sch. 11 para. 12(2) word inserted by S.I. 2019/775 reg. 63(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 63(3) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(4))
- Sch. 11 para. 12(5) word inserted by S.I. 2019/775 reg. 63(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 63(3) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(4))
- Sch. 11 para. 12(1) words inserted by S.I. 2019/775 reg. 63(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 63(3) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(4))
- Sch. 11 para. 12(2) words inserted by S.I. 2019/775 reg. 63(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 63(3) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(4))
- Sch. 11 para. 12(5) words inserted by S.I. 2019/775 reg. 63(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 63(3) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 7(4))
- Sch. 11 para. 14(a) words substituted by S.I. 2019/775 reg. 63(4) (This amendment not applied to legislation.gov.uk. Reg. 63(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 46(b))
- Sch. 12 para. 21 words substituted by S.I. 2019/775 reg. 115(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 115(3)(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 86)
- Sch. 17 Pt. 1 table word inserted by S.I. 2019/775 reg. 193(2) (This amendment not applied to legislation.gov.uk. Reg. 193(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 147(a))
- Sch. 17 Pt. 4 table word inserted by S.I. 2019/775 reg. 193(3) (This amendment not applied to legislation.gov.uk. Reg. 193(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 147(b))
- Sch. 24 para. 18A omitted by S.I. 2019/775 reg. 201(4) (This amendment not applied to legislation.gov.uk. Reg. 201(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 155(c))
- Sch. 27 para. 12 omitted by S.I. 2019/775 reg. 204(4) (This amendment not applied to legislation.gov.uk. Reg. 204(4) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(c))
- Sch. 27 para. 11(f) words substituted by S.I. 2019/775 reg. 204(3) (This amendment not applied to legislation.gov.uk. Reg. 204(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(b))
- Sch. 27 para. 13 words substituted by S.I. 2019/775 reg. 204(5)(a) (This amendment not applied to legislation.gov.uk. Reg. 204(5)(a) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 158(d))
- Sch. 30 para. 1 words substituted by S.I. 2019/775 reg. 216 (This amendment not applied to legislation.gov.uk. Reg. 216 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 173)
- Sch. 30 para. 2 words substituted by S.I. 2019/775 reg. 216 (This amendment not applied to legislation.gov.uk. Reg. 216 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 173)
- Sch. 30 para. 6 words substituted by S.I. 2019/775 reg. 216 (This amendment not applied to legislation.gov.uk. Reg. 216 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 173)
- reg. 3(12)(d)(ii) word inserted by S.I. 2019/775 reg. 5(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 5(2)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 2(a))
- reg. 3(12)(d)(iv) and word omitted by S.I. 2019/775 reg. 5(2)(c) (This amendment not applied to legislation.gov.uk. Reg. 5(2)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 2(a))
- reg. 3(15)(b) word inserted by S.I. 2019/775 reg. 5(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 5(3)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 2(b))
- reg. 3(15)(d) and word omitted by S.I. 2019/775 reg. 5(3)(c) (This amendment not applied to legislation.gov.uk. Reg. 5(3)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 2(b))
- reg. 5(1)(b) and word omitted by S.I. 2019/775 reg. 7(2) (This amendment not applied to legislation.gov.uk. Reg. 7(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(a))
- reg. 5(2)(b) word inserted by S.I. 2019/775 reg. 7(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 7(3)(a) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 4(b)(i))
- reg. 5(2)(d) and word omitted by S.I. 2019/775 reg. 7(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 7(3)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(b)(ii))
- reg. 5(3)(b) omitted by S.I. 2019/775 reg. 7(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 7(4)(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(c)(i))
- reg. 5(3)(d) words omitted by S.I. 2019/775 reg. 7(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 7(4)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 4(c)(ii))
- reg. 5(4)(b) and word omitted by S.I. 2019/775 reg. 7(5) (This amendment not applied to legislation.gov.uk. Reg. 7(5) amended immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 4(d))
- reg. 5(5)(b) omitted by S.I. 2019/775 reg. 7(6)(a) (This amendment not applied to legislation.gov.uk. Reg. 7(6)(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 4(e)(i))
- reg. 5(5)(d) words omitted by S.I. 2019/775 reg. 7(6)(b) (This amendment not applied to legislation.gov.uk. Reg. 7(6)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 4(e)(ii))
- reg. 6(3)(b) and word omitted by S.I. 2019/775 reg. 9(a) (This amendment not applied to legislation.gov.uk. Reg. 9 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 6)
- reg. 6(4) omitted by S.I. 2019/775 reg. 9(b) (This amendment not applied to legislation.gov.uk. Reg. 9 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 6)
- reg. 6(5) omitted by S.I. 2019/775 reg. 9(b) (This amendment not applied to legislation.gov.uk. Reg. 9 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 6)
- reg. 8(1) word omitted by S.I. 2024/374 Sch. 5 para. 19(a)
- reg. 8(1) words inserted by S.I. 2019/775 reg. 10(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 10(3)(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(ii))
- reg. 8(1) words inserted by S.I. 2024/374 Sch. 5 para. 19(b)
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(3)(d) (This amendment not applied to legislation.gov.uk. Reg. 10(3)(d) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(iv))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(3)(j) (This amendment not applied to legislation.gov.uk. Reg. 10(3)(j) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(vi))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(3)(k) (This amendment not applied to legislation.gov.uk. Reg. 10(3)(k) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 7(b)(vii))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(i) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(i) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(ii) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(ii) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(iv) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(iv) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(ix) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(ix) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(vii) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(vii) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(viii) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(viii) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(x) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(x) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(xi) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(xi) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 8(1) words omitted by S.I. 2019/775 reg. 10(4)(xii) (This amendment not applied to legislation.gov.uk. Reg. 10(4)(xii) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 7(c))
- reg. 17(1)(a) words substituted by S.I. 2019/775 reg. 14(2) (This amendment not applied to legislation.gov.uk. Reg. 14(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 9(a))
- reg. 17(3)(a) words substituted by S.I. 2019/775 reg. 14(3) (This amendment not applied to legislation.gov.uk. Reg. 14(3) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 9(b))
- reg. 17(4) omitted by S.I. 2019/775 reg. 14(4) (This amendment not applied to legislation.gov.uk. Reg. 14(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 9(c))
- reg. 17(5) words substituted by S.I. 2019/775 reg. 14(5) (This amendment not applied to legislation.gov.uk. Reg. 14(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 9(d))
- reg. 18(1)(c) words omitted by virtue of S.I. 2019/775, reg. 15(2)(c) (as amended) by S.I. 2019/1385 Sch. 1 para. 2 (This amendment not applied to legislation.gov.uk. Sch. 1 paras. 2-6 omitted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 3 para. 1(a))
- reg. 18(6) words substituted by S.I. 2019/775 reg. 15(3) (This amendment not applied to legislation.gov.uk. Reg. 15(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 10(c))
- reg. 18(7) omitted by S.I. 2019/775 reg. 15(4) (This amendment not applied to legislation.gov.uk. Reg. 15(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 10(d))
- reg. 19(1)(a) words substituted by S.I. 2019/775 reg. 17(2) (This amendment not applied to legislation.gov.uk. Reg. 17(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 11(a))
- reg. 19(6) inserted by S.I. 2019/775, reg. 17(4) (as inserted) by S.I. 2019/1385 Sch. 1 para. 3 (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. 26(5)(a) words substituted by S.I. 2019/775 reg. 21 (This amendment not applied to legislation.gov.uk. Reg. 21 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 15)
- reg. 31(5)(a) word inserted by S.I. 2019/775 reg. 24(3) (This amendment not applied to legislation.gov.uk. Reg. 24(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 16)
- reg. 36(4)-(7) omitted by S.I. 2019/775 reg. 27 (This amendment not applied to legislation.gov.uk. Reg. 27 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 17)
- reg. 37(4)(b) words substituted by S.I. 2019/775 reg. 28(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 28(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(b))
- reg. 37(4)(b) words substituted by S.I. 2019/775 reg. 28(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 28(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(b))
- reg. 37(5)(b) words substituted by S.I. 2019/775 reg. 28(3) (This amendment not applied to legislation.gov.uk. Reg. 28(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(c))
- reg. 37(6)(b) words substituted by S.I. 2019/775 reg. 28(4) (This amendment not applied to legislation.gov.uk. Reg. 28(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 18(d))
- reg. 38(2) words substituted by S.I. 2019/775 reg. 29(3) (This amendment not applied to legislation.gov.uk. Reg. 29(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(b))
- reg. 38(3)(b) words substituted by S.I. 2019/775 reg. 29(3) (This amendment not applied to legislation.gov.uk. Reg. 29(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 19(b))
- reg. 42(1) word substituted by S.I. 2019/775 reg. 31(2) (This amendment not applied to legislation.gov.uk. Reg. 31(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(a))
- reg. 42(4) omitted by S.I. 2019/775 reg. 31(3) (This amendment not applied to legislation.gov.uk. Reg. 31(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 21(b))
- reg. 43(1) words substituted by S.I. 2019/775 reg. 33(2) (This amendment not applied to legislation.gov.uk. Reg. 33(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(a))
- reg. 43(5)(a) words substituted by S.I. 2019/775 reg. 33(3) (This amendment not applied to legislation.gov.uk. Reg. 33(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(b))
- reg. 43(6)(b) substituted by S.I. 2019/775 reg. 33(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 33(4)(b) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(d)(i))
- reg. 43(7)(b)(i) words substituted by S.I. 2019/775 reg. 33(5)(a)(i) (This amendment not applied to legislation.gov.uk. Reg. 33(5)(a)(i) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(f)(i))
- reg. 43(7)(b)(ii) words substituted by S.I. 2019/775 reg. 33(3) (This amendment not applied to legislation.gov.uk. Reg. 33(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(b))
- reg. 43(7)(b)(ii) words substituted by S.I. 2019/775 reg. 33(5)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 33(5)(a)(ii) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(f)(ii))
- reg. 43(7)(c)(vii) omitted by S.I. 2019/775 reg. 33(5)(b) (This amendment not applied to legislation.gov.uk. Reg. 33(5)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(g))
- reg. 43(8)(8A) substituted for reg. 43(8) by S.I. 2019/775 reg. 33(6) (This amendment not applied to legislation.gov.uk. Reg. 33(6) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(i)(i)(ii))
- reg. 43(10) omitted by S.I. 2019/775 reg. 33(7) (This amendment not applied to legislation.gov.uk. Reg. 33(7) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(j))
- reg. 43(11) omitted by S.I. 2019/775 reg. 33(7) (This amendment not applied to legislation.gov.uk. Reg. 33(7) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(j))
- reg. 43(13) word inserted by S.I. 2019/775 reg. 33(8) (This amendment not applied to legislation.gov.uk. Reg. 33(8) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(k))
- reg. 43(15) omitted by S.I. 2019/775 reg. 33(9) (This amendment not applied to legislation.gov.uk. Reg. 33(9) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 23(l))
- reg. 43A omitted by S.I. 2019/775 reg. 34 (This amendment not applied to legislation.gov.uk. Reg. 34 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 24)
- reg. 44(2)(b) words substituted by S.I. 2019/775 reg. 35(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 35(2)(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(a)(i))
- reg. 44(2)(c) words substituted by S.I. 2019/775 reg. 35(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 35(2)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(a)(ii))
- reg. 44(5)(b) words substituted by S.I. 2019/775 reg. 35(3) (This amendment not applied to legislation.gov.uk. Reg. 35(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(b))
- reg. 44(5)(e) words substituted by S.I. 2019/775 reg. 35(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 35(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(c))
- reg. 44(5)(e) words substituted by S.I. 2019/775 reg. 35(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 35(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(c))
- reg. 44(6)(e) and word omitted by S.I. 2019/775 reg. 35(5)(b) (This amendment not applied to legislation.gov.uk. Reg. 35(5)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 25(d))
- reg. 45(1) words substituted by S.I. 2019/775 reg. 36(2) (This amendment not applied to legislation.gov.uk. Reg. 36(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 26(a))
- reg. 45(2)(b) words substituted by S.I. 2019/775 reg. 36(3) (This amendment not applied to legislation.gov.uk. Reg. 36(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 26(b))
- reg. 45A(1)(a)(i)(ii) substituted by S.I. 2019/775 reg. 38(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 38(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(a))
- reg. 45A(1)(b)(i) words substituted by S.I. 2019/775 reg. 38(2)(b)(i) (This amendment not applied to legislation.gov.uk. Reg. 38(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(a))
- reg. 45A(1)(b)(iii) words substituted by S.I. 2019/775 reg. 38(2)(b)(iii) (This amendment not applied to legislation.gov.uk. Reg. 38(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(a))
- reg. 45A(1)(b)(ii) words omitted by S.I. 2019/775 reg. 38(2)(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 38(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(a))
- reg. 45A(2)(a) words substituted by S.I. 2019/775 reg. 38(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 38(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b))
- reg. 45A(2)(c) words substituted by S.I. 2019/775 reg. 38(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 38(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 28(b))
- reg. 45E(3)(b)(i) words substituted by S.I. 2019/775 reg. 40(a) (This amendment not applied to legislation.gov.uk. Reg. 40(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 29(a))
- reg. 45E(3)(d)(iii) omitted by S.I. 2019/775 reg. 40(b) (This amendment not applied to legislation.gov.uk. Reg. 40(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 29(b))
- reg. 45M(2)(a) words substituted by S.I. 2019/775 reg. 42(2) (This amendment not applied to legislation.gov.uk. Reg. 42(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 31)
- reg. 45O(1) words substituted by S.I. 2019/775 reg. 44(2) (This amendment not applied to legislation.gov.uk. Reg. 44(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(a))
- reg. 45O(2) words substituted by S.I. 2019/775 reg. 44(3) (This amendment not applied to legislation.gov.uk. Reg. 44(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(b))
- reg. 45O(3) words substituted by S.I. 2019/775 reg. 44(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 44(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c))
- reg. 45O(3) words substituted by S.I. 2019/775 reg. 44(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 44(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c))
- reg. 45O(3)(c) word omitted by S.I. 2019/775 reg. 44(4)(c)(i) (This amendment not applied to legislation.gov.uk. Reg. 44(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c))
- reg. 45O(3)(c)(iii) words substituted by S.I. 2019/775 reg. 44(4)(c)(iii) (This amendment not applied to legislation.gov.uk. Reg. 44(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c))
- reg. 45O(3)(c)(ii) words substituted by S.I. 2019/775 reg. 44(4)(c)(ii) (This amendment not applied to legislation.gov.uk. Reg. 44(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(c))
- reg. 45O(4)(a) words substituted by S.I. 2019/775 reg. 44(5)(a) (This amendment not applied to legislation.gov.uk. Reg. 44(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e))
- reg. 45O(4)(b)(i) words substituted by S.I. 2019/775 reg. 44(5)(b) (This amendment not applied to legislation.gov.uk. Reg. 44(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 32(e))
- reg. 46(2)(b) word inserted by S.I. 2019/775 reg. 45(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 45(2)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(a))
- reg. 46(2)(d) and word omitted by S.I. 2019/775 reg. 45(2)(c) (This amendment not applied to legislation.gov.uk. Reg. 45(2)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(a))
- reg. 46(6)(a) word inserted by S.I. 2019/775 reg. 45(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 45(4)(a)-(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b))
- reg. 46(6)(b) word inserted by S.I. 2019/775 reg. 45(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 45(4)(a)-(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b))
- reg. 46(6)(d) and word omitted by S.I. 2019/775 reg. 45(4)(c) (This amendment not applied to legislation.gov.uk. Reg. 45(4)(a)-(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 33(b))
- reg. 46(7)(b) and word omitted by S.I. 2019/775 reg. 45(5) (This amendment not applied to legislation.gov.uk. Reg. 45(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 33(c))
- reg. 47(6) words substituted by S.I. 2019/775 reg. 46(3) (This amendment not applied to legislation.gov.uk. Reg. 46(3) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 34)
- reg. 48(2) words inserted by S.I. 2019/775, reg. 47(2)(a) (as amended) by S.I. 2019/1385 Sch. 1 para. 4(a) (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. 48(2) words inserted by S.I. 2019/775, reg. 47(2)(d) (as amended) by S.I. 2019/1385 Sch. 1 para. 4(b)(ii) (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. 48(2) words omitted by virtue of S.I. 2019/775, reg. 47(2)(d) (as amended) by S.I. 2019/1385 Sch. 1 para. 4(b)(i) (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. 49(1A) inserted by S.I. 2019/775 reg. 48(3) (This amendment not applied to legislation.gov.uk. Reg. 48(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(a)(i)(ii))
- reg. 49(3) words substituted by S.I. 2019/775 reg. 48(4) (This amendment not applied to legislation.gov.uk. Reg. 48(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(b))
- reg. 49(9) inserted by S.I. 2019/775 reg. 48(6) (This amendment not applied to legislation.gov.uk. Reg. 48(6) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 36(c)(i)(ii))
- reg. 50(4) words omitted by S.I. 2019/775 reg. 49(2) (This amendment not applied to legislation.gov.uk. Reg. 49(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 37(b))
- reg. 51 substituted by S.I. 2019/775 reg. 56 (This amendment not applied to legislation.gov.uk. Reg. 56 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 41)
- reg. 52(1)(b) substituted by S.I. 2019/775 reg. 57(3) (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. 52(2) substituted by S.I. 2019/775 reg. 57(4) (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. 52(3) words substituted by S.I. 2019/775 reg. 57(5)(a) (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. 52(3) words substituted by S.I. 2019/775 reg. 57(5)(b) (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(1) words substituted by S.I. 2019/775 reg. 58(2) (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(3) words substituted by S.I. 2019/775 reg. 58(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 58(4)(a) substituted immediately before IP completion day by S.I. 2019/1385, reg. 1, Sch. 1 para. 6(3))
- reg. 53(3) words substituted by S.I. 2019/775, reg. 58(4)(a) (as substituted) by S.I. 2019/1385 Sch. 1 para. 6(3) (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)(a) words omitted by S.I. 2019/775 reg. 60(2) (This amendment not applied to legislation.gov.uk. Reg. 60 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 44)
- reg. 55(2) substituted by S.I. 2019/775 reg. 60(3) (This amendment not applied to legislation.gov.uk. Reg. 60 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 44)
- reg. 58(6) omitted by S.I. 2019/775 reg. 62(3) (This amendment not applied to legislation.gov.uk. Reg. 62(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(b))
- reg. 58(7) omitted by S.I. 2019/775 reg. 62(3) (This amendment not applied to legislation.gov.uk. Reg. 62(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 45(b))
- reg. 59(3) substituted by S.I. 2019/775 reg. 65(2) (This amendment not applied to legislation.gov.uk. Reg. 65(2) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 48(b))
- reg. 59(3A)(3B) inserted by S.I. 2019/775 reg. 65(3) (This amendment not applied to legislation.gov.uk. Reg. 65(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 48(c))
- reg. 59(5) omitted by S.I. 2019/775 reg. 65(6) (This amendment not applied to legislation.gov.uk. Reg. 65(6) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 48(d))
- reg. 60(9) omitted by S.I. 2019/775 reg. 66 (This amendment not applied to legislation.gov.uk. Reg. 66 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 49)
- reg. 60A inserted by S.I. 2019/775 reg. 67 (This amendment not applied to legislation.gov.uk. Reg. 67 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 50(c))
- reg. 61(6) substituted by S.I. 2019/775 reg. 68(3) (This amendment not applied to legislation.gov.uk. Reg. 68(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(c))
- reg. 61(7)-(7B) substituted for reg. 61(7) by S.I. 2019/775 reg. 68(4) (This amendment not applied to legislation.gov.uk. Reg. 68(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(e))
- reg. 61(13) omitted by S.I. 2019/775 reg. 68(5) (This amendment not applied to legislation.gov.uk. Reg. 68(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 51(f))
- reg. 64(4)(d) words substituted by S.I. 2019/775 reg. 69 (This amendment not applied to legislation.gov.uk. Reg. 69 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 52)
- reg. 66(2) words substituted by S.I. 2019/775 reg. 74 (This amendment not applied to legislation.gov.uk. Reg. 74 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 55)
- reg. 68(7) words substituted by S.I. 2019/775 reg. 77(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 77(3)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 57(a))
- reg. 68(9) omitted by S.I. 2019/775 reg. 77(5) (This amendment not applied to legislation.gov.uk. Reg. 77(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 57(b))
- reg. 71(1)(b) word inserted by S.I. 2019/775 reg. 80(2)(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 80(2)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 58)
- reg. 71(1)(b) words omitted by S.I. 2019/775 reg. 80(2)(b)(i) (This amendment not applied to legislation.gov.uk. Reg. 80(2)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 58)
- reg. 72(1) words omitted by S.I. 2019/775 reg. 81 (This amendment not applied to legislation.gov.uk. Reg. 81 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 59)
- reg. 73(5C) omitted by S.I. 2019/775 reg. 82(3) (This amendment not applied to legislation.gov.uk. Reg. 82(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 60)
- reg. 76(2) words substituted by S.I. 2019/775 reg. 84 (This amendment not applied to legislation.gov.uk. Reg. 84 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 61)
- reg. 77 word inserted by S.I. 2019/775 reg. 85 (This amendment not applied to legislation.gov.uk. Reg. 85 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 62)
- reg. 78 word inserted by S.I. 2019/775 reg. 86 (This amendment not applied to legislation.gov.uk. Reg. 86 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 63)
- reg. 79 omitted by S.I. 2019/775 reg. 88 (This amendment not applied to legislation.gov.uk. Reg. 88 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 65)
- reg. 80(a) words substituted by S.I. 2019/775 reg. 89(3) (This amendment not applied to legislation.gov.uk. Reg. 89(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 66(a))
- reg. 80(b) words substituted by S.I. 2019/775 reg. 89(4) (This amendment not applied to legislation.gov.uk. Reg. 89(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 66(b))
- reg. 80(c) substituted by S.I. 2019/775 reg. 89(5) (This amendment not applied to legislation.gov.uk. Reg. 89(5) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 66(d)(i)(ii))
- reg. 81-94 omitted by S.I. 2019/775 reg. 90 (This amendment not applied to legislation.gov.uk. Reg. 90 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 67)
- reg. 94A omitted by S.I. 2019/775 reg. 91 (This amendment not applied to legislation.gov.uk. Reg. 91 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 68)
- reg. 95 word inserted by S.I. 2019/775 reg. 92(2) (This amendment not applied to legislation.gov.uk. Reg. 92 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 69)
- reg. 95(c) omitted by S.I. 2019/775 reg. 92(3) (This amendment not applied to legislation.gov.uk. Reg. 92 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 69)
- reg. 95(d) omitted by S.I. 2019/775 reg. 92(3) (This amendment not applied to legislation.gov.uk. Reg. 92 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 69)
- reg. 96(1) word inserted by S.I. 2019/775 reg. 93(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 93 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 70)
- reg. 96(1)(b) omitted by S.I. 2019/775 reg. 93(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 93 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 70)
- reg. 96(1)(c) omitted by S.I. 2019/775 reg. 93(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 93 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 70)
- reg. 96(2) words substituted by S.I. 2019/775 reg. 93(3) (This amendment not applied to legislation.gov.uk. Reg. 93 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 70)
- reg. 97 words substituted by S.I. 2019/775 reg. 94(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 94(2) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 71)
- reg. 97 words substituted by S.I. 2019/775 reg. 94(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 94(2) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 71)
- reg. 98(2)(a) word inserted by S.I. 2019/775 reg. 95 (This amendment not applied to legislation.gov.uk. Reg. 95 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 72)
- reg. 99(1) words omitted by S.I. 2019/775 reg. 96(2) (This amendment not applied to legislation.gov.uk. Reg. 96 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 73)
- reg. 99(2) omitted by S.I. 2019/775 reg. 96(3) (This amendment not applied to legislation.gov.uk. Reg. 96 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 73)
- reg. 101(1) word inserted by S.I. 2019/775 reg. 97(2) (This amendment not applied to legislation.gov.uk. Reg. 97 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 74)
- reg. 101(3) words substituted by S.I. 2019/775 reg. 97(3) (This amendment not applied to legislation.gov.uk. Reg. 97 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 74)
- reg. 103(4) words substituted by S.I. 2019/775 reg. 99(2) (This amendment not applied to legislation.gov.uk. Reg. 99(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 76(b))
- reg. 104(5) omitted by S.I. 2019/775 reg. 100 (This amendment not applied to legislation.gov.uk. Reg. 100 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 77)
- reg. 104(6) omitted by S.I. 2019/775 reg. 100 (This amendment not applied to legislation.gov.uk. Reg. 100 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 77)
- reg. 108(2) words substituted by S.I. 2019/775 reg. 101 (This amendment not applied to legislation.gov.uk. Reg. 101 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 78)
- reg. 110(7) words substituted by S.I. 2019/775 reg. 102(2) (This amendment not applied to legislation.gov.uk. Reg. 102 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 80)
- reg. 110(10) omitted by S.I. 2019/775 reg. 102(3) (This amendment not applied to legislation.gov.uk. Reg. 102 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 80)
- reg. 116(2) words substituted by S.I. 2019/775 reg. 107 (This amendment not applied to legislation.gov.uk. Reg. 107 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 81)
- reg. 125(5)(b) words substituted by S.I. 2019/775 reg. 110 (This amendment not applied to legislation.gov.uk. Reg. 110 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 82)
- reg. 127(3) words substituted by S.I. 2019/775 reg. 113 (This amendment not applied to legislation.gov.uk. Reg. 113 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 84)
- reg. 128(3) words substituted by S.I. 2019/775 reg. 114 (This amendment not applied to legislation.gov.uk. Reg. 114 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 85)
- reg. 130(7) words substituted by S.I. 2019/775 reg. 116(3) (This amendment not applied to legislation.gov.uk. Reg. 116(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 87(a))
- reg. 130(8) words substituted by S.I. 2019/775 reg. 116(4) (This amendment not applied to legislation.gov.uk. Reg. 116(4) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 87(b))
- reg. 130(9) omitted by S.I. 2019/775 reg. 116(5) (This amendment not applied to legislation.gov.uk. Reg. 116(5) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 87(c))
- reg. 130(10)(a) words substituted by S.I. 2019/775 reg. 116(6) (This amendment not applied to legislation.gov.uk. Reg. 116(6) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 87(d))
- reg. 130(12) omitted by S.I. 2019/775 reg. 116(7) (This amendment not applied to legislation.gov.uk. Reg. 116(7) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 87(e))
- reg. 130(13) omitted by S.I. 2019/775 reg. 116(7) (This amendment not applied to legislation.gov.uk. Reg. 116(7) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 87€)
- reg. 133(2) words substituted by S.I. 2019/775 reg. 118 (This amendment not applied to legislation.gov.uk. Reg. 118 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 89)
- reg. 135(7)(b) words substituted by S.I. 2019/775 reg. 119(2) (This amendment not applied to legislation.gov.uk. Reg. 119(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 91(b))
- reg. 135(8) omitted by S.I. 2019/775 reg. 119(3) (This amendment not applied to legislation.gov.uk. Reg. 119(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 91(c))
- reg. 135(9)(b) and word omitted by S.I. 2019/775 reg. 119(4) (This amendment not applied to legislation.gov.uk. Reg. 119(4) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 91(d))
- reg. 136(1)(a) words substituted by S.I. 2019/775 reg. 120(2) (This amendment not applied to legislation.gov.uk. Reg. 120(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 92)
- reg. 140(1)(a) words substituted by S.I. 2019/775 reg. 123 (This amendment not applied to legislation.gov.uk. Reg. 123 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 93)
- reg. 142(5C) omitted by S.I. 2019/775 reg. 125 (This amendment not applied to legislation.gov.uk. Reg. 125 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 94)
- reg. 144 words substituted by S.I. 2019/775 reg. 127 (This amendment not applied to legislation.gov.uk. Reg. 127 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 96)
- reg. 146(2) words substituted by S.I. 2019/775 reg. 129 (This amendment not applied to legislation.gov.uk. Reg. 129 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 97)
- reg. 149(a) words substituted by S.I. 2019/775 reg. 131(3) (This amendment not applied to legislation.gov.uk. Reg. 131 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 98)
- reg. 149(b) words substituted by S.I. 2019/775 reg. 131(4) (This amendment not applied to legislation.gov.uk. Reg. 131 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 98)
- reg. 149(c) substituted by S.I. 2019/775 reg. 131(5) (This amendment not applied to legislation.gov.uk. Reg. 131 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 98)
- reg. 159(1) words substituted by S.I. 2019/775 reg. 133(b) (This amendment not applied to legislation.gov.uk. Reg. 133(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 100)
- reg. 164(2)(b) words substituted by S.I. 2019/775 reg. 134(b) (This amendment not applied to legislation.gov.uk. Reg. 134(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 101)
- reg. 168(8)(a) words substituted by S.I. 2019/775 reg. 135(a) (This amendment not applied to legislation.gov.uk. Reg. 135 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 103)
- reg. 168(8)(b) substituted by S.I. 2019/775 reg. 135(b) (This amendment not applied to legislation.gov.uk. Reg. 135 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 103)
- reg. 169(9)(a) word inserted by S.I. 2019/775 reg. 136 (This amendment not applied to legislation.gov.uk. Reg. 136 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 104)
- reg. 171(2)(c) words substituted by S.I. 2019/775 reg. 137 (This amendment not applied to legislation.gov.uk. Reg. 137 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 105)
- reg. 173(c) word inserted by S.I. 2019/775 reg. 138 (This amendment not applied to legislation.gov.uk. Reg. 138 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 106)
- reg. 173(d) words inserted by S.I. 2017/1322 Sch. 4 para. 2(2)(a) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(i).)
- reg. 177(1) words omitted by S.I. 2019/775 reg. 139(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 139(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 107(a))
- reg. 177(1) words substituted by S.I. 2019/775 reg. 139(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 139(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 107(a))
- reg. 177(1)(a) word inserted by S.I. 2019/775 reg. 139(2)(c) (This amendment not applied to legislation.gov.uk. Reg. 139(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 107(a))
- reg. 177(1)(c) and word omitted by S.I. 2019/775 reg. 139(2)(d) (This amendment not applied to legislation.gov.uk. Reg. 139(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 107(a))
- reg. 177(2)(a) word inserted by S.I. 2019/775 reg. 139(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 139(3)(b)(c) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 107(b))
- reg. 177(2)(c) and word omitted by S.I. 2019/775 reg. 139(3)(c) (This amendment not applied to legislation.gov.uk. Reg. 139(3)(b)(c) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 107(b))
- reg. 177(3)(a) word inserted by S.I. 2019/775 reg. 139(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 139(4)(b)(c) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 107(c))
- reg. 177(3)(c) and word omitted by S.I. 2019/775 reg. 139(4)(c) (This amendment not applied to legislation.gov.uk. Reg. 139(4)(b)(c) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 107(c))
- reg. 177(4) omitted by S.I. 2019/775 reg. 139(5) (This amendment not applied to legislation.gov.uk. Reg. 139(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 107(d))
- reg. 177(5) word omitted by virtue of S.I. 2019/775, reg. 139(6)(b) (as substituted) by S.I. 2019/1385 Sch. 1 para. 8 (This amendment not applied to legislation.gov.uk. Sch. 1 para. 8 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(b))
- reg. 177(5) word omitted by virtue of S.I. 2019/775, reg. 139(6)(d) (as substituted) by S.I. 2019/1385 Sch. 1 para. 8 (This amendment not applied to legislation.gov.uk. Sch. 1 para. 8 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(b))
- reg. 177(5) words inserted by S.I. 2019/775, reg. 139(6)(c) (as substituted) by S.I. 2019/1385 Sch. 1 para. 8 (This amendment not applied to legislation.gov.uk. Sch. 1 para. 8 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(b))
- reg. 177(5) words omitted by S.I. 2019/775 reg. 139(6) (This amendment not applied to legislation.gov.uk. Reg. 139(6) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 107(e))
- reg. 177(5) words substituted by S.I. 2019/775, reg. 139(6)(a) (as substituted) by S.I. 2019/1385 Sch. 1 para. 8 (This amendment not applied to legislation.gov.uk. Sch. 1 para. 8 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 3 para. 1(b))
- reg. 181 omitted by S.I. 2019/775 reg. 141 (This amendment not applied to legislation.gov.uk. Reg. 141 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 110)
- reg. 182(2)(a) words substituted by S.I. 2019/775 reg. 142(2) (This amendment not applied to legislation.gov.uk. Reg. 142(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 111(a))
- reg. 182(3) words inserted by S.I. 2019/775 reg. 142(3) (This amendment not applied to legislation.gov.uk. Reg. 142(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 111(c))
- reg. 186(1)(a) word inserted by S.I. 2019/775 reg. 145(a) (This amendment not applied to legislation.gov.uk. Reg. 145 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 113)
- reg. 186(1)(c)-(e) omitted by S.I. 2019/775 reg. 145(b) (This amendment not applied to legislation.gov.uk. Reg. 145 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 113)
- reg. 187(1) words substituted by S.I. 2019/775 reg. 147(2) (This amendment not applied to legislation.gov.uk. Reg. 147(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 114)
- reg. 188(2) omitted by S.I. 2019/775 reg. 148(4) (This amendment not applied to legislation.gov.uk. Reg. 148(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 115(c))
- reg. 188(3) omitted by S.I. 2019/775 reg. 148(4) (This amendment not applied to legislation.gov.uk. Reg. 148(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 115(c))
- reg. 189(2)-(4) omitted by S.I. 2019/775 reg. 149(3) (This amendment not applied to legislation.gov.uk. Reg. 149(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 116)
- reg. 190(1) words omitted by S.I. 2019/775 reg. 150 (This amendment not applied to legislation.gov.uk. Reg. 150 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 117)
- reg. 191(1) words substituted by S.I. 2019/775 reg. 151(2) (This amendment not applied to legislation.gov.uk. Reg. 151(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 118(a))
- reg. 191(3) words omitted by S.I. 2019/775 reg. 151(4)(a) (This amendment not applied to legislation.gov.uk. Reg. 151(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 118(b))
- reg. 191(3) words omitted by S.I. 2019/775 reg. 151(4)(b) (This amendment not applied to legislation.gov.uk. Reg. 151(4) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 118(b))
- reg. 191(7) words substituted by S.I. 2019/775 reg. 151(2) (This amendment not applied to legislation.gov.uk. Reg. 151(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 118(a))
- reg. 191(10) words substituted by S.I. 2019/775 reg. 151(7) (This amendment not applied to legislation.gov.uk. Reg. 151(7) substituted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 118(e))
- reg. 192(3) words substituted by S.I. 2019/775 reg. 152(3) (This amendment not applied to legislation.gov.uk. Reg. 152(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 119(a))
- reg. 192(9)-(11) omitted by S.I. 2019/775 reg. 152(4) (This amendment not applied to legislation.gov.uk. Reg. 152(4) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 119(b))
- reg. 193(1)(a) omitted by S.I. 2019/775 reg. 153(2) (This amendment not applied to legislation.gov.uk. Reg. 153(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 120(a))
- reg. 193(2) substituted by S.I. 2019/775 reg. 153(3) (This amendment not applied to legislation.gov.uk. Reg. 153(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 120(c)(i)(ii))
- reg. 193(4) substituted by S.I. 2019/775 reg. 153(4) (This amendment not applied to legislation.gov.uk. Reg. 153(4) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 120(d)(i)(ii))
- reg. 193(5) words substituted by S.I. 2019/775 reg. 153(5)(a) (This amendment not applied to legislation.gov.uk. Reg. 153(5)(a) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 120(e)(i))
- reg. 193(5) words substituted by S.I. 2019/775 reg. 153(5)(b) (This amendment not applied to legislation.gov.uk. Reg. 153(5)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 120(e)(ii))
- reg. 193(6)(6A) substituted for reg. 193(6) by S.I. 2019/775 reg. 153(6) (This amendment not applied to legislation.gov.uk. Reg. 153(6) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 120(f)(i)(ii))
- reg. 194 omitted by S.I. 2019/775 reg. 154 (This amendment not applied to legislation.gov.uk. Reg. 154 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 121)
- reg. 195(1) substituted by S.I. 2019/775 reg. 155(3) (This amendment not applied to legislation.gov.uk. Reg. 155(3) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 122(b)(i)-(iii))
- reg. 195(4) words omitted by S.I. 2019/775 reg. 155(5) (This amendment not applied to legislation.gov.uk. Reg. 155(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 122(c))
- reg. 197 omitted by S.I. 2019/775 reg. 157 (This amendment not applied to legislation.gov.uk. Reg. 157 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 125)
- reg. 198(2) words substituted by S.I. 2019/775 reg. 158(2) (This amendment not applied to legislation.gov.uk. Reg. 158(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 126(a))
- reg. 198(3)(c) words substituted by S.I. 2019/775 reg. 158(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 158(3)(a) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 126(b)(i))
- reg. 198(3)(d) words substituted by S.I. 2019/775 reg. 158(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 158(3)(b) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 126(b)(ii))
- reg. 199(2) words substituted by S.I. 2019/775 reg. 159(2) (This amendment not applied to legislation.gov.uk. Reg. 159(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 127(a))
- reg. 199(3) omitted by S.I. 2019/775 reg. 159(3) (This amendment not applied to legislation.gov.uk. Reg. 159(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 127(b))
- reg. 199(4) omitted by S.I. 2019/775 reg. 159(3) (This amendment not applied to legislation.gov.uk. Reg. 159(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 127(b))
- reg. 199(5) words omitted by S.I. 2019/775 reg. 159(4) (This amendment not applied to legislation.gov.uk. Reg. 159(4)-(6) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 127(c))
- reg. 199(6)(b) and word omitted by S.I. 2019/775 reg. 159(5) (This amendment not applied to legislation.gov.uk. Reg. 159(4)-(6) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 127(c))
- reg. 199(7) omitted by S.I. 2019/775 reg. 159(6) (This amendment not applied to legislation.gov.uk. Reg. 159(4)-(6) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 127(c))
- reg. 199(8) omitted by S.I. 2019/775 reg. 159(6) (This amendment not applied to legislation.gov.uk. Reg. 159(4)-(6) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 127©)
- reg. 200(2) words substituted by S.I. 2019/775 reg. 160(2) (This amendment not applied to legislation.gov.uk. Reg. 160(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 128(a))
- reg. 200(3) omitted by S.I. 2019/775 reg. 160(3) (This amendment not applied to legislation.gov.uk. Reg. 160(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 128(b))
- reg. 200(4) omitted by S.I. 2019/775 reg. 160(3) (This amendment not applied to legislation.gov.uk. Reg. 160(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 128(b))
- reg. 200(5) words omitted by S.I. 2019/775 reg. 160(4) (This amendment not applied to legislation.gov.uk. Reg. 160(4)(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 128(c))
- reg. 200(6) omitted by S.I. 2019/775 reg. 160(5) (This amendment not applied to legislation.gov.uk. Reg. 160(4)(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 128(c))
- reg. 200(7) omitted by S.I. 2019/775 reg. 160(5) (This amendment not applied to legislation.gov.uk. Reg. 160(4)(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 128(c))
- reg. 201(2) words substituted by S.I. 2019/775 reg. 161(2) (This amendment not applied to legislation.gov.uk. Reg. 161(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 129(a))
- reg. 201(3) omitted by S.I. 2019/775 reg. 161(3) (This amendment not applied to legislation.gov.uk. Reg. 161(3) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 129(b))
- reg. 201(4) words omitted by S.I. 2019/775 reg. 161(4) (This amendment not applied to legislation.gov.uk. Reg. 161(4) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 129(c))
- reg. 202 omitted by S.I. 2019/775 reg. 162 (This amendment not applied to legislation.gov.uk. Reg. 162 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 130)
- reg. 203(2)(e) words substituted by S.I. 2019/775 reg. 164(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 164(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 131)
- reg. 203(2)(f) words omitted by S.I. 2019/775 reg. 164(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 164(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 131)
- reg. 204 omitted by S.I. 2019/775 reg. 165 (This amendment not applied to legislation.gov.uk. Reg. 165 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 132)
- reg. 205(2) words substituted by S.I. 2019/775 reg. 166(2) (This amendment not applied to legislation.gov.uk. Reg. 166(2) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 133(a))
- reg. 205(3) omitted by S.I. 2019/775 reg. 166(3) (This amendment not applied to legislation.gov.uk. Reg. 166(3) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 133(b))
- reg. 206(1) word omitted by S.I. 2019/775 reg. 170(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 170(2)(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 135)
- reg. 206(1) words inserted by S.I. 2019/775 reg. 170(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 170(2)(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 135)
- reg. 206(3) omitted by S.I. 2019/775 reg. 170(3) (This amendment not applied to legislation.gov.uk. Reg. 170(2)(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 135)
- reg. 206(4) omitted by S.I. 2019/775 reg. 170(3) (This amendment not applied to legislation.gov.uk. Reg. 170(2)(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 135)
- reg. 208 words omitted by S.I. 2019/775 reg. 172 (This amendment not applied to legislation.gov.uk. Reg. 172 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 136)
- reg. 209(3)(h) omitted by S.I. 2019/775 reg. 173 (This amendment not applied to legislation.gov.uk. Reg. 173 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 136)
- reg. 209(3)(i) omitted by S.I. 2019/775 reg. 173 (This amendment not applied to legislation.gov.uk. Reg. 173 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 136)
- reg. 210 omitted by S.I. 2019/775 reg. 174 (This amendment not applied to legislation.gov.uk. Reg. 174 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 136)
- reg. 210A(1)(a) words substituted by S.I. 2019/775 reg. 175(3)(a) (This amendment not applied to legislation.gov.uk. Reg. 175(3)(a)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 137(b))
- reg. 210A(1)(b) words omitted by S.I. 2019/775 reg. 175(3)(b)(ii) (This amendment not applied to legislation.gov.uk. Reg. 175(3)(a)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 137(b))
- reg. 210A(1)(b) words substituted by S.I. 2019/775 reg. 175(3)(b)(i) (This amendment not applied to legislation.gov.uk. Reg. 175(3)(a)(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 137(b))
- reg. 210A(2)-(4) substituted for reg. 210A(2) by S.I. 2019/775 reg. 175(4) (This amendment not applied to legislation.gov.uk. Reg. 175(4) amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 137(c))
- reg. 211 words omitted by S.I. 2019/775 reg. 176 (This amendment not applied to legislation.gov.uk. Reg. 176 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 138)
- reg. 212 words substituted by S.I. 2019/775 reg. 177 (This amendment not applied to legislation.gov.uk. Reg. 177 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 139)
- 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. 230(8) words substituted by S.I. 2019/775 reg. 188 (This amendment not applied to legislation.gov.uk. Reg. 188 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 142)
- reg. 231(8) words substituted by S.I. 2019/775 reg. 189 (This amendment not applied to legislation.gov.uk. Reg. 189 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 143)
- reg. 232(8) words substituted by S.I. 2019/775 reg. 190 (This amendment not applied to legislation.gov.uk. Reg. 190 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 144)
- reg. 233(7) words substituted by S.I. 2019/775 reg. 191 (This amendment not applied to legislation.gov.uk. Reg. 191 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 145)
- reg. 234(9) words substituted by S.I. 2019/775 reg. 192 (This amendment not applied to legislation.gov.uk. Reg. 192 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 146)
- reg. 240(1)(a) substitited by S.I. 2017/1322 Sch. 4 para. 2(3)(a) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(2) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(b) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(4) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(d) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(4) words inserted by virtue of by S.I. 2017/1322 Sch. 4 para. 2(3)(e) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(6) words inserted by S.I. 2017/1322 Sch. 4 para. 2(3)(f) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 240(7) substitited by S.I. 2017/1322 Sch. 4 para. 2(3)(h) (This amendment not applied to legislation.gov.uk: superseded by S.I. 2018/121, reg. 2(4)(b)(ii).)
- reg. 249(2)(b) word inserted by S.I. 2019/775 reg. 194(b) (This amendment not applied to legislation.gov.uk. Reg. 194(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 148)
- reg. 249(2)(d) and word omitted by S.I. 2019/775 reg. 194(c) (This amendment not applied to legislation.gov.uk. Reg. 194(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 148)
- reg. 255A-255C omitted by S.I. 2019/775 reg. 196 (This amendment not applied to legislation.gov.uk. Reg. 196 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 150)
- reg. 257A omitted by S.I. 2019/775 reg. 199 (This amendment not applied to legislation.gov.uk. Reg. 199 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 153)
- reg. 257B omitted by S.I. 2019/775 reg. 199 (This amendment not applied to legislation.gov.uk. Reg. 199 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 153)
- reg. 259(2) words substituted by S.I. 2019/775 reg. 202 (This amendment not applied to legislation.gov.uk. Reg. 202 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 156)
- reg. 266(1) words omitted by S.I. 2019/775 reg. 205(2) (This amendment not applied to legislation.gov.uk. Reg. 205 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 159)
- reg. 266(2) omitted by S.I. 2019/775 reg. 205(3) (This amendment not applied to legislation.gov.uk. Reg. 205 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 159)
- reg. 266(3) omitted by S.I. 2019/775 reg. 205(3) (This amendment not applied to legislation.gov.uk. Reg. 205 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 159)
- reg. 267 words substituted by S.I. 2019/775 reg. 206 (This amendment not applied to legislation.gov.uk. Reg. 206 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 160)
- reg. 268(1) words substituted by S.I. 2019/775 reg. 207(2) (This amendment not applied to legislation.gov.uk. Reg. 207(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b))
- reg. 269(1) words substituted by S.I. 2019/775 reg. 208(2) (This amendment not applied to legislation.gov.uk. Reg. 208(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b))
- reg. 270(2) words substituted by S.I. 2019/775 reg. 209 (This amendment not applied to legislation.gov.uk. Reg. 209 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 165)
- reg. 279(a) word inserted by S.I. 2019/775 reg. 211(a) (This amendment not applied to legislation.gov.uk. Reg. 211 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 167)
- reg. 279(b) word inserted by S.I. 2019/775 reg. 211(b) (This amendment not applied to legislation.gov.uk. Reg. 211 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 167)
- reg. 279(d) and word omitted by S.I. 2019/775 reg. 211(c) (This amendment not applied to legislation.gov.uk. Reg. 211 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 167)
- reg. 280(1) words omitted by S.I. 2019/775 reg. 212(b) (This amendment not applied to legislation.gov.uk. Reg. 212(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 168(c))
- reg. 280(1) words substituted by S.I. 2019/775 reg. 212(a) (This amendment not applied to legislation.gov.uk. Reg. 212 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 168(a)(b))
- reg. 281(1)(b) word inserted by S.I. 2019/775 reg. 213(b) (This amendment not applied to legislation.gov.uk. Reg. 213(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 169)
- reg. 281(1)(d) and word omitted by S.I. 2019/775 reg. 213(c) (This amendment not applied to legislation.gov.uk. Reg. 213(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 169)
- reg. 293(1) word inserted by S.I. 2019/775 reg. 214(a) (This amendment not applied to legislation.gov.uk. Reg. 214 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 171)
- reg. 293(1) words omitted by S.I. 2019/775 reg. 214(c) (This amendment not applied to legislation.gov.uk. Reg. 214 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 171)
- reg. 293(1) words substituted by S.I. 2019/775 reg. 214(b) (This amendment not applied to legislation.gov.uk. Reg. 214 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 171)
- reg. 295(2)(d) word inserted by S.I. 2019/775 reg. 215(a) (This amendment not applied to legislation.gov.uk. Reg. 215 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 172)
- reg. 295(2)(d) words omitted by S.I. 2019/775 reg. 215(c) (This amendment not applied to legislation.gov.uk. Reg. 215 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 172)
- reg. 295(2)(d) words substituted by S.I. 2019/775 reg. 215(b) (This amendment not applied to legislation.gov.uk. Reg. 215 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 172)
- reg. 299(3) words substituted by S.I. 2019/775 reg. 217 (This amendment not applied to legislation.gov.uk. Reg. 217 amended immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 176)
- reg. 321(5)(d) omitted by S.I. 2019/775 reg. 218(b) (This amendment not applied to legislation.gov.uk. Reg. 218(b) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 178)
- reg. 322(1) words omitted by S.I. 2019/775 reg. 219(b) (This amendment not applied to legislation.gov.uk. Reg. 219 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 179)
- reg. 322(1) words substituted by S.I. 2019/775 reg. 219(a) (This amendment not applied to legislation.gov.uk. Reg. 219 omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 179)
- reg. 327(1)(c)(viii) and word omitted by S.I. 2019/775 reg. 221(2)(c) (This amendment not applied to legislation.gov.uk. Reg. 221(2)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(a))
- reg. 327(1)(c)(vi) word inserted by S.I. 2019/775 reg. 221(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 221(2)(b)(c) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(a))
- reg. 327(2)(g)(v) omitted by S.I. 2019/775 reg. 221(3)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 221(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(b))
- reg. 327(2)(g)(iii) omitted by S.I. 2019/775 reg. 221(3)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 221(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(b))
- reg. 327(2)(g)(ii) words inserted by S.I. 2019/775 reg. 221(3)(a)(i) (This amendment not applied to legislation.gov.uk. Reg. 221(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(b))
- reg. 327(2)(g)(iv) omitted by S.I. 2019/775 reg. 221(3)(a)(ii) (This amendment not applied to legislation.gov.uk. Reg. 221(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(b))
- reg. 327(2)(h) omitted by S.I. 2019/775 reg. 221(3)(b) (This amendment not applied to legislation.gov.uk. Reg. 221(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 180(b))
- reg. 327(4A) omitted by S.I. 2019/775 reg. 221(4) (This amendment not applied to legislation.gov.uk. Reg. 221(4)(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 180(c))
- reg. 327(5)(a) words substituted by S.I. 2019/775 reg. 221(5)(a) (This amendment not applied to legislation.gov.uk. Reg. 221(4)(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 180(c))
- reg. 327(5)(b) words omitted by S.I. 2019/775 reg. 221(5)(b) (This amendment not applied to legislation.gov.uk. Reg. 221(4)(5) omitted immediately before IP completion day by virtue of S.I. 2020/1488, reg. 1, Sch. 2 para. 180(c))
- reg. 331(1) word inserted by S.I. 2019/775 reg. 222(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 222(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 181(a))
- reg. 331(1)(c) and word omitted by S.I. 2019/775 reg. 222(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 222(2) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 181(a))
- reg. 331(4)(c) substituted by S.I. 2019/775 reg. 222(3) (This amendment not applied to legislation.gov.uk. Reg. 222(3) substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 181(b))
- reg. 341(4)(a) word inserted by S.I. 2019/775 reg. 224 (This amendment not applied to legislation.gov.uk. Reg. 224 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 184)
- reg. 345(5) word inserted by S.I. 2019/775 reg. 226(a) (This amendment not applied to legislation.gov.uk. Reg. 226 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 186)
- reg. 345(5) word inserted by S.I. 2019/775 reg. 226(b) (This amendment not applied to legislation.gov.uk. Reg. 226 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 186)
- reg. 345(5) words omitted by S.I. 2019/775 reg. 226(c) (This amendment not applied to legislation.gov.uk. Reg. 226 substituted immediately before IP completion day by S.I. 2020/1488, reg. 1, Sch. 2 para. 186)
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. 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))
- 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. 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).)
Information:
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Introductory Text
PART 1 General
1.Citation and commencement
2.Medicinal products
2A.Definition of advanced therapy medicinal product etc.
3.Scope of these Regulations: special provisions
3A.Preparation and assembly of medicinal products used for vaccination or immunisation against coronavirus or in the reformulation of such products
4.Special provisions for pharmacies etc
5.Classification of medicinal products
6.The licensing authority and the Ministers
7.Advertisements relating to medicinal products
8.General interpretationNext Match
PART 2 Administration
9.Commission on Human Medicines
10.Functions of the Commission
11.British Pharmacopoeia Commission
12.Reporting to Ministers
13.Co-option of additional members of advisory bodies
14.Appointment of expert advisory groups
15.Delegation of functions to expert advisory groups
16.Further provision about advisory bodies and expert advisory groups etc
PART 3 Manufacture and distribution of medicinal products and active substances
CHAPTER 1 Interpretation
A17.Interpretation
Chapter 1A Good manufacturing practice and good distribution practice
B17.Regulations on good manufacturing practice
C17.Guidelines on good manufacturing practice and good distribution practice
CHAPTER 2 Manufacturing and wholesale dealing
Grant etc of licences
17.Manufacturing of medicinal products
18.Wholesale dealing in medicinal products
18A.Approved country for import
19.Exemptions from requirement for wholesale dealer's licencePrevious MatchNext Match
20.Mixing of medicines
21.Application for manufacturer's or wholesale dealer's licence
22.Factors relevant to determination of application for manufacturer's or wholesale dealer's licence
23.Grant or refusal of licence
24.Standard provisions of licences
25.Duration of licence
26.General power to suspend, revoke or vary licences
27.Procedure where licensing authority proposes to suspend, revoke or vary licence
28.Suspension of licence in cases of urgency
29.Variation of licence on the application of the holder
30.Provision of information
Miscellaneous and offences
31.Certification of manufacturer's licence
32.Sale and supply of starting materials
33.Offence concerning data for advanced therapy medicinal products
34.Offences: breach of regulations and false information and defence concerning starting materials
35.Penalties
Conditions for holding a manufacturer's licence
36.Conditions for manufacturer's licence
37.Manufacturing and assembly
38.Imports from states other than EEA States / countries other than approved countries for import
39.Further requirements for manufacturer's licence
40.Obligation to provide information relating to control methods
41.Requirements as to qualified persons
Conditions for holding a wholesale dealer's licence
42.Conditions for wholesale dealer's licence
43.Obligations of licence holder
43ZA.Obligations of licence holder in Great Britain supplying listed NIMAR products to Northern Ireland
43A.Requirement for wholesale dealers to decommission the unique identifier
44.Requirement for wholesale dealers to deal only with specified persons
45.Requirement as to responsible persons
45AA.Requirement as to responsible persons where licence holder imports from an approved country for import
45AB.Register for responsible persons (import)
CHAPTER 3 Brokering
45A.Brokering in medicinal products
45B.Application for brokering registration
45C.Procedure for determining an application for broker’s registration
45D.Grant or refusal of broker’s registration
45E.Criteria of broker’s registration
45F.Provision of information
45G.Power to suspend or vary a broker’s registration or remove a broker from the register
45H.Procedure where licensing authority proposes to suspend or vary a broker’s registration or remove a broker from the register
45I.Suspension of a broker registration in cases of urgency
45J.Variation of a broker’s registration on the application of the broker
45K.Offences: breach of regulations and false information
45L.Penalties
CHAPTER 4 Importation, manufacture and distribution of active substances
45M.Criteria for importation, manufacture or distribution of active substances
45N.Registration in relation to active substances
45O.Requirements for registration as an importer, manufacturer or distributor of an active substance
45P.Provision of information
45Q.Power to suspend or vary or remove an active substance registration
45R.Procedure where licensing authority proposes to suspend or vary an active substance registration or remove a person from the active substance register
45S.Suspension of an active substance registration in cases of urgency
45T.Variation of an active substance registration on an application from the registered person
45U.Offences: breach of regulations and false information
45V.Penalties
PART 4 Requirement for authorisation
46.Requirement for authorisation
47.Breach of requirement
PART 5 Marketing authorisations
48.Application of this Part
Application for UK marketing authorisation
49.Application for grant of UK marketing authorisation or parallel import licence
50.Accompanying material
50A.Requirement for certain applications to include results of paediatric investigation plan
50B.Agreement and modification of paediatric investigation plan
50C.Deferral of initiation or completion of measures in paediatric investigation plan
50D.Waiver of production of information in a paediatric investigation plan
50E.Application for paediatric use marketing authorisation
50F.Other applications including paediatric indications
50G.Applications relating to orphan medicinal products
50H.Applications relating to advanced therapy medicinal products
50I.Applications relating to conditional marketing authorisations for sale or supply in Great Britain only
50J.Applications in relation to medicinal products containing or consisting of genetically modified organisms
51.Application for UKMA(NI) relating to generic medicinal products
51A.Application for UKMA(GB) relating to generic medicinal products
51B.Application for UKMA(UK) relating to generic medicinal products
52.Application for UKMA(NI) relating to certain medicinal products that do not qualify as generic etc
52A.Application for UKMA(GB) relating to certain medicinal products that do not qualify as generic etc
52B.Application for UKMA(UK) relating to certain medicinal products that do not qualify as generic etc
53.Application for UKMA(NI) relating to similar biological medicinal products
53A.Application for UKMA(GB) relating to similar biological medicinal products
53B.Application for UKMA(UK) relating to similar biological medicinal products
54.Applications relating to products in well-established medicinal use
55.Applications relating to new combinations of active substances
56.Applications containing information supplied in relation to another product with consent
57.Obligation to update information supplied in connection with application
57A.Obligation to update information supplied in connection with parallel import licence application
Consideration of application
58.Consideration of application
58A.Paediatric rewards
58B.Publication of information relating to paediatric marketing authorisations
58C.Consideration of applications relating to orphan medicinal products
58D.Orphan rewards
58E.Consideration of applications relating to combined advanced therapy medicinal products
58F.Consideration of applications relating to conditional marketing authorisations
58G.Consideration of applications in relation to medicinal products containing or consisting of genetically modified organisms
59.Conditions of UK marketing authorisation or parallel import licence: general
60.Conditions of UK marketing authorisation or parallel import licence: exceptional circumstances
60A.Condition as to the submitting of samples and other information to the appropriate authority
60B.Submitting of samples and other information: EU marketing authorisations
61.Conditions of UK marketing authorisation: new obligations post-authorisation
62.Classification of UK marketing authorisation or parallel import licence
63.Frequency of periodic safety update reports
64.Duties of licensing authority in connection with determination
64A.Obligation of licensing authority in case of change of classification
Validity of UK marketing authorisation
65.Validity of UK marketing authorisation
65A.Validity of parallel import licence
65B.Validity of conditional marketing authorisation
65C.Variation of a UKMA(GB)
66.Application for renewal of authorisation
66A.Application for renewal of a parallel import licence
66B.Renewal of conditional marketing authorisation
67.Failure to place on the market etc
Revocation, variation and suspension of marketing authorisation
68.Revocation, variation and suspension of UK marketing authorisation or parallel import licence
69.Suspension of use etc of relevant medicinal product
70.Authorisations granted under Chapter 4 of Title III of the 2001 Directive
71.Withdrawal of medicinal product from the market
72.Sale etc of suspended medicinal product
Obligations of holder of marketing authorisation
73.Obligation to notify placing on the market etc
74.Obligation to take account of scientific and technical progress
75.Obligation to provide information relating to safety etc
76.Obligation in relation to product information
77.Record-keeping obligations
78.Obligation to ensure appropriate and continued supplies
78A.Post authorisation requirements in relation to UK marketing authorisations to which paediatric specific provisions apply
78B.Post authorisation requirements in relation to UKMA(GB) for advanced therapy medicinal products
Offences relating to specific requirements
79.Failure to provide information on marketing authorisations to EMA
80.Urgent safety restrictions
80A.Urgent safety restrictions: parallel import licences
Offences relating to EU marketing authorisations
A81.Application of regulations 81 to 94
81.Obligation to update information supplied in connection with EU application
82.EU marketing authorisations: failure to notify placing on market etc
83.EU marketing authorisations: failure to take account of technical and scientific progress
84.EU marketing authorisations: failure to provide information as to safety etc
85.EU marketing authorisations: failure to update product information
86.EU marketing authorisations: breach of pharmacovigilance condition etc
Offences relating to advanced therapy medicinal products
87.Offences in connection with risk management systems and traceability systems
88.Offence concerning data for advanced therapy medicinal products
Offences relating to the Paediatric Regulation
89.Offences in connection with withdrawal of product from the market
90.Failure to place on the market taking account of paediatric indication
91.Failure to notify results of third country clinical trials
92.Failure of sponsor of UK paediatric clinical trial to notify results of trial
93.Failure to notify results of paediatric study
94.Failure to submit report to EMA
Offences relating to the safety features appearing on the packaging of medicinal products
94A.Offences relating to Commission Regulation 2016/161
General provisions relating to offences
95.Offences in connection with application
95A.Offences in connection with parallel import licence application
96.Provision of false or misleading information
97.Breach of pharmacovigilance condition
98.General offence of breach of provision of this Part
99.Penalties
100.Persons liable
101.Defences
PART 6 Certification of homoeopathic medicinal products
Application of Part
102.Application of Part
Application for certificate of registration and consideration of application
103.Application for certificate of registration
104.Consideration of application
105.Conditions of certificate of registration
106.Classification of certificate of registration
107.Validity of certificate of registration
108.Application for renewal of certificate
109.Failure to place on the market etc
Revocation, variation and suspension of certificate of registration
110.Revocation, variation and suspension of certificate of registration
111.Certificates granted under Chapter 4 of Title III of the 2001 Directive
112.Withdrawal of homoeopathic medicinal product from the market
Obligations of holder of certificate of registration
113.Obligation to notify placing on the market etc
114.Obligation to take account of scientific and technical progress
115.Obligation to provide information relating to safety etc
116.Obligation in relation to product information
117.Record-keeping obligation
118.Obligation to ensure appropriate and continued supplies
Provisions relating to offences
119.Offences in connection with applications
120.Provision of false or misleading information
121.General offence of breach of provision of this Part
122.Penalties
123.Persons liable
124.Defences
PART 7 Traditional herbal registrations
Interpretation and application of Part
124A.Interpretation of this Part
125.Traditional herbal medicinal products
125A.List of approved countries for traditional use of a herbal medicinal product
126.Addition of vitamins or minerals
List of herbal substances, preparations and combinations for use in traditional herbal medicinal products
126A.Licensing authority list as to herbal substances, preparations and combinations for use in traditional herbal medicinal products
Application for traditional herbal registration
127.Application for grant of traditional herbal registration
128.Accompanying material
129.Obligation to update information supplied in connection with application
Consideration of application
130.Consideration of application
130A.Procedure where less than 15 years use of traditional herbal medicinal product
131.Classification of traditional herbal registration
Validity of traditional herbal registration
132.Validity of traditional herbal registration
133.Application for renewal of registration
134.Failure to place on the market etc
Revocation, variation and suspension of traditional herbal registration
135.Revocation, variation and suspension of traditional herbal registration
136.Revocation by licensing authority: further provisions
137.Procedures for revocation, variation or suspension
138.Suspension of use etc of traditional herbal medicinal product
139.Registrations granted under Chapter 4 of Title III of the 2001 Directive
140.Withdrawal of traditional herbal medicinal product from the market
141.Sale etc of suspended traditional herbal medicinal product
Obligations of holder of traditional herbal registration
142.Obligation to notify placing on the market etc
143.Obligation to take account of scientific and technical progress
143A.Establishment of herbal monographs
144.Obligation following new herbal monograph
145.Obligation to provide information relating to safety etc
146.Obligation in relation to product information
147.Record-keeping obligations
148.Obligation to ensure appropriate and continued supplies
148A.Urgent safety restrictions
Offences relating to traditional herbal registrations
149.Urgent safety restrictions
150.Offences in connection with applications
151.Provision of false or misleading information
152.General offence of breach of provision of this Part
153.Penalties
154.Persons liable
155.Defences
PART 8 Article 126a authorisations
156.Article 126a authorisations
157.Requests from EU member States
158.Application of these Regulations
PART 9 Borderline products
159.Provisional determination
160.Challenge to provisional determination
161.Written representations procedure
162.Oral representations procedure
163.Final determination without representations
164.Effect of final determination
165.Determination in other cases
166.Offences relating to borderline products
PART 10 Exceptions to requirement for marketing authorisation etc
Exceptions
167.Supply to fulfil special patient needs
167A.NIMAR supply to Northern Ireland
167B.List of NIMAR products
167C.Early Access to Medicines Scheme: establishment and licensing authority functions
167D.EAMS scientific opinions ceasing to have effect
167E.EAMS medicinal products: manufacture, assembly, importation, distribution and supply
167F.Advertising of EAMS medicinal products
167G.EAMS medicinal products: pharmacovigilance
167H.Early Access to Medicines Scheme: data collection
168.Use of non-prescription medicines in the course of a business
169.Mixing of general sale medicinal products
170.Record-keeping requirements
171.Exempt advanced therapy medicinal products
172.Parallel import licences
173.Exemption for certain radiopharmaceuticals
174.Supply in response to spread of pathogenic agents etc
174A.Conditions of temporary authorisations under regulation 174
Offences
175.Offences relating to exceptions
176.Penalties and supplementary provision about offences
PART 11 Pharmacovigilance
177.Application of this Part and interpretation
Obligations on licensing authority in relation to pharmacovigilance
178.General obligations of the licensing authority
179.Obligation on licensing authority to operate pharmacovigilance system
180.Obligation on licensing authority to audit pharmacovigilance system
181.Delegation of obligations under this Part
Obligations on holders in relation to pharmacovigilance system
182.Obligation on holder to operate pharmacovigilance system
183.Exception to obligation to operate risk management system
184.Obligation on holder to audit pharmacovigilance system
Recording, reporting and assessment of pharmacovigilance data
185.Recording obligations on the licensing authority
186.Reporting obligations on the licensing authority
186A.The licensing authority must collaborate with the World Health Organisation...
187.Recording obligations on holders
188.Reporting obligations on holders
Signal detection
189.Signal detection: licensing authority obligations
190.Signal detection: holder obligation
Periodic Safety Update Reports
191.Obligation on holder to submit periodic safety update reports: general requirements
191A.Obligation on holder of a parallel import licence to submit periodic safety update reports
192.Obligation on holder to submit periodic safety update reports: derogation from general requirements
193.Harmonisation of PSUR frequency or date of submission
194.Responding to a single assessment of PSUR under Article 107e of the 2001 Directive
195.Obligation on licensing authority to assess PSURs ...
Urgent action and major safety review
196.Urgent action
196A.Major safety review by the licensing authority
197.EU urgent action procedure
Post-authorisation safety studies
198.Post-authorisation safety studies: general provisions
199.Submission of draft study protocols for required studies
200.Amendment to study protocols for required studies
201.Submission and evaluation of final study reports for required studies
202.Follow-up of final study reports
Medicinal products subject to additional monitoring
202A.Licensing authority power in relation to medicinal products subject to additional monitoring
Transparency and communications
203.Obligations on licensing authority in relation to national medicines web-portal
204.Obligation on licensing authority in relation to public announcements
205.Obligations on holders in relation to public announcements
Further obligations in respect of pharmacovigilance activities
205A.Further obligations in respect of pharmacovigilance activities
Guidance in respect of pharmacovigilance
205B.Guidance in respect of good pharmacovigilance practice and post authorisation efficacy studies
Enforcement
206.Infringement notices
207.Offences
208.False and misleading information
209.Penalties
210.Offences relating to pharmacovigilance obligations under Regulation (EC) No 726/2004
210A.Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A
211.Persons liable
Transitional arrangements
212.Transitional arrangements
PART 12 Dealings with medicinal products
CHAPTER 1 Interpretation
213.Interpretation
CHAPTER 2 Sale and supply of medicines
Prescription only medicines
214.Sale or supply of prescription only medicines
215.Prescribing and administration by supplementary prescribers
216.Exceptions to regulation 215
217.Requirements for prescriptions: general
217A.Requirements for prescriptions to be dispensed in an EEA state ...
217B.Original pack dispensing
217BA.Original pack dispensing: Northern Ireland
217C.Original pack dispensing: medicinal products containing a relevant substance
217CA.Original pack dispensing: medicinal products containing a relevant substance: Northern Ireland
218.Requirements for prescriptions: approved country health professional
219.Electronic prescriptions
219A.Electronic Prescriptions: approved country health professionals
Medicines not subject to general sale
220.Sale or supply of medicinal products not subject to general sale
General sale medicines
221.Sale or supply of medicinal products subject to general sale
222.Sale of medicinal products from automatic machines
CHAPTER 3 Exemptions
Exemptions relating to supply in specific circumstances
223.Exemptions for doctors and dentists etc
224.Emergency sale etc by pharmacist: prescriber unable to provide prescription
225.Emergency sale etc by pharmacist: at patient's request
226.Emergency sale etc by pharmacist: pandemic diseases
226A.Sale etc by a pharmacist in accordance with a serious shortage protocol
227.Exemption for sale or supply in hospitals
228.Exemptions relating to prescriptions given by certain health professionals
229.Exemption for supply by national health service bodies and local authorities
230.Exemption for supply etc under a PGD to assist doctors or dentists
231.Exemption for supply etc under a PGD by independent hospitals etc
232.Exemption for supply etc under a PGD by dental practices and clinics: England and Wales
233.Exemption for supply etc under a PGD by person conducting a retail pharmacy business
234.Exemption for supply etc of products under a PGD to assist the police etc
235.Exemption for sale, supply or administration by certain persons
Exemptions in relation to specific kinds of product
236.Products consisting of or containing aloxiprin, aspirin or paracetamol
237.Products consisting of or containing pseudoephedrine salts or ephedrine base or salts
238.Administration of certain medicines in an emergency
239.Administration of smallpox vaccine
240.Radioactive medicinal products
241.Exemptions in respect of certain herbal remedies
242.Exemption for medicinal products at high dilution
243.Exemption for certain homoeopathic medicinal products
Other exemptions
244.Exemption in cases involving another's default
245.Exemption in case of forged prescription
246.Exemption where requirements for prescriptions not met
247.Exemption for supply in the event or anticipation of pandemic disease
247A.Protocols relating to coronavirus and influenza vaccinations and immunisations
248.Exemption for certain collection and delivery arrangements
CHAPTER 4 Miscellaneous provisions, offences and disqualification
Miscellaneous provisions
249.Restrictions on persons to be supplied with medicinal products
250.Exceptions to regulation 249
251.Compliance with standards specified in certain publications
252.Compliance with standards specified in certain publications: supplementary
253.Pharmacy recordsPrevious MatchNext Match
254.Prohibitions concerning traceability of treatment with advanced therapy medicinal products
255.Offences relating to dealings with medicinal products
255A.Enforcement notices relating to Commission Regulation 2016/161: persons authorised to supply medicinal products to the public
255B.Exception to Article 25 of Commission Regulation 2016/161: health care institutions
255C.Offences relating to Commission Regulation 2016/161: management of the repository system
Disqualification
256.Disqualification on conviction
PART 12A Sale of medicines to the public at a distance
256ZA.Application of Part
256A.Interpretation
256B.Person who may sell medicinal products by information society services
256C.Notification requirements for sellers of medicinal products at a distance
256D.Procedure for listing persons who may supply medicinal products at a distance
256E.Removal of a person’s entry from the list
256F.Provision of information to the licensing authority
256G.Grant or refusal to list a person
256H.Conditions to be met by a person entered on the list
256I.Power to suspend, vary or remove a person’s entry on the list
256J.Procedure where the licensing authority proposes to suspend, vary or remove a person’s entry on the list
256K.Suspension of a person’s entry on the list in cases of urgency
256L.Variation of a person’s entry on the list on the application of that person
256M.Offences: breach of regulations and false information
256N.Penalties
PART 13 Packaging and leaflets
CHAPTER 1
Requirements for packaging and package leaflets relating to medicinal products
257.Packaging requirements: general
257A.Packaging Requirements: medicinal products required to bear safety features
257B.Transitional Arrangements
257C.Packaging requirements: advanced therapy medicinal products
257D.Guidance as to packaging and package leaflets
257E.Regulation-making power as to certain forms of labelling
258.Packaging requirements: specific provisions
259.Packaging requirements: information for blind and partially sighted patients
260.Package leaflets
261.Use of pictures and symbols etc
262.Labelling requirements for radionuclides
263.Leaflets relating to radionuclides
264.Homoeopathic medicines
265.Additional requirements for traditional herbal medicinal products
266.Language requirements etc
267.Submission of mock-ups of packaging and leaflets to licensing authority
Enforcement and offences
268.Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etc
268A. Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc
269.Offences relating to packaging and package leaflets in Great Britain: other persons
269A. Offences relating to packaging and package leaflets in Northern Ireland: other persons
270.Non-compliance with requirements of this Part
271.Offences: penalties
CHAPTER 2
Requirements relating to child safety
272.Interpretation
273.Child resistant containers for regulated medicinal products
274.Exemptions from regulation 273
275.Colouring of aspirin and paracetamol products for children
276.Offences
PART 14 Advertising
CHAPTER 1 General
277.Interpretation
278.Functions of the Ministers
CHAPTER 2 Requirements relating to advertising
General
279.Products without a marketing authorisation etc
280.General principles
281.Duties of authorisation holders and registration holders
Advertising to the public
282.Application of regulations 283 to 292
283.Products for the purpose of inducing abortions
284.Prescription only medicines
284A. Medicines with differing classification status in Great Britain and Northern Ireland
285.Narcotic and psychotropic substances
286.Material relating to diagnosis
287.Material about effects of medicinal product
288.Material about status of medicinal product
289.Recommendations by scientists etc
290.Advertisements directed at children
291.Form and content of advertisement
291A.Campaigns relating to the suspected or confirmed spread of pathogenic agents etc.
292.Exception for approved vaccination campaigns
Prohibition of supply to the public for promotional purposes
293.Prohibition of supply to the public for promotional purposes
Advertising to persons qualified to prescribe or supply etc
294.General requirements
295.Abbreviated advertisements
296.Exception for advertisements intended as a reminder
297.Written material accompanying promotions
298.Free samples for persons qualified to prescribe or supply medicinal products
299.Medical sales representatives
300.Inducements and hospitality
Homoeopathic medicinal products
301.Advertisements for registered homoeopathic medicinal products
Traditional herbal medicinal products
302.Advertisements for traditional herbal medicinal products
Offences
303.Offences
CHAPTER 3 Monitoring of Advertising
Scrutiny by Ministers
304.Requirement to provide copy advertisement
305.Invitation to make representations about compatibility
306.Decision about compatibility
307.Corrective statement
308.Offences
Complaints to Ministers
309.Complaints to Ministers: duty to consider
310.Complaints to Ministers: power to refer
Injunctions
311.Application for injunction
312.Application for injunction: accuracy of factual claim
313.Grant of injunction: publication of decision and corrective statement
Complaints to OFCOM
314.Complaints to OFCOM
General
315.Public interest etc
316.Civil proceedings
PART 15 British Pharmacopoeia
317.British Pharmacopoeia and compendia
318.Lists of names
319.Other documents
320.Supplementary provisions
321.Specified publications
PART 16 Enforcement
322.Validity of decisions and proceedings
323.Enforcement in England, Wales and Scotland
324.Enforcement in Northern Ireland
325.Rights of entry
326.Application for warrant
327.Powers of inspection, sampling and seizure
328.Regulation 327: supplementary
329.Application of sampling procedure to substance or article seized under this Part
330.Analysis of samples: other cases
331.Findings and reports of inspections
331A.Guidelines on inspections
332.Restrictions on disclosure of information
333.Protection for inspectors
334.Supplementary provisions and offences
PART 17 Miscellaneous and general
Provisions relating to offences
335.Contravention due to fault of another person
336.Warranty as defence
337.Offences in relation to warranties and certificates
338.Offences by bodies corporate and partnerships
Prosecutions
339.Prosecutions
General
340.Presumptions
341.Decisions under these Regulations
342.Time limits for provision of information etc
343.Service of documents
344.Payment of expenses by Ministers
344A.Modifications to deal with serious shortages
344B.Regulation making powers
Immunity from civil liability
345.Immunity from civil liability
345A.Obligation on licensing authority to maintain list of medicinal products to which derogations have applied
Review
346.Review
Transitional provisions, savings, amendments, repeals and revocations
347.Transitional provisions and savings
347A.Transitional provision in relation to EU exit
348.Amendments to existing law
349.Repeals and revocations
Signature
SCHEDULES
SCHEDULE 1
Further provisions for classification of medicinal products
PART 1 Descriptions of certain medicinal products to be available only on prescription
1.The following medicinal products shall be available only on prescription—...
2.In this Part “cyanogenic substances” means preparations which—
PART 2 Descriptions of certain medicinal products to be available only from a pharmacy
3.The following medicinal products shall be available only from a...
4.The following medicinal products shall be available only from a...
5.A medicinal product shall be available only from a pharmacy...
SCHEDULE 2
Supplementary provision relating to advisory bodies and expert advisory groups
Terms of appointment
1.(1) The person appointed to chair an advisory body is...
2.(1) A member of an advisory body, other than its...
3.(1) The person appointed to chair an expert advisory group...
4.(1) This paragraph applies to a member of an expert...
Facilities and proceedings
5.The Ministers must provide each advisory body with such staff,...
6.The validity of any proceedings of an advisory body or...
7.(1) An advisory body may, subject to approval by the...
Payment and expenses
8.The Ministers may pay to the members of each advisory...
9.The Ministers must defray any expenses incurred with their approval...
10.If an action is brought against a person arising out...
11.Paragraphs 8 to 10 shall have effect in relation to...
Status
12.An advisory body or expert advisory group is not to...
SCHEDULE 2A
Modifications of Commission Directive 2003/94/EC
SCHEDULE 3
Applications for licences under Part 3
Manufacturer's licences
1.(1) This paragraph applies to an application for a manufacturer's...
Manufacturers' licence relating to import
2.(1) This paragraph applies to an application for a manufacturer's...
Wholesale dealer's licences
3.(1) This paragraph applies to an application for a wholesale...
All licences
4.(1) If an application does not include information or other...
SCHEDULE 4
Standard provisions of licences under Part 3
PART 1 Manufacturer's licence relating to manufacture and assembly
1.The provisions of this Part are standard provisions of a...
2.The licence holder must place the quality control system referred...
3.The licence holder may use a contract laboratory pursuant to...
4.The licence holder must provide such information as may be...
5.The licence holder must inform the licensing authority of any...
6.The licence holder must— (a) keep readily available for inspection...
7.The licence holder must keep readily available for examination by...
8.Where the licence holder has been informed by the licensing...
9.The licence holder must ensure that tests for determining conformity...
10.Where the manufacturer's licence relates to the assembly of a...
11.Where— (a) the manufacturer's licence relates to the assembly of...
12.The licence holder must keep readily available for examination by...
13.Where— (a) animals are used in the production of medicinal...
14.The licence holder must take all reasonable precautions and exercise...
14A.A licence holder— (a) in Great Britain may only supply...
14B.A licence holder may only manufacture or assemble EAMS medicinal...
PART 2 Manufacturer's licence relating to the import of medicinal products from a state other than an EEA State / Country other than an Approved Country for Import
15.The provisions of this Part are standard provisions of a...
15A.The provisions of this Part are standard provisions of a...
16.The licence holder must place the quality control system referred...
17.The licence holder may use a contract laboratory pursuant to...
18.The licence holder must provide such information as may be...
19.The licence holder must— (a) keep readily available for inspection...
20.Where the licence holder has been informed by the licensing...
21.The licence holder must ensure that any tests for determining...
22.(1) Where and in so far as the licence relates...
23.The licence holder must take all reasonable precautions and exercise...
23ZA.The licence holder in Great Britain must take all reasonable...
23A.A licence holder— (a) in Great Britain may only supply...
23B.A licence holder may only import EAMS medicinal products if...
PART 3 Manufacturer's licence relating to exempt advanced therapy medicinal products
24.The provisions of paragraphs 25 to 27 are incorporated as...
25.The licence holder must ensure that the immediate packaging of...
26.The licence holder must ensure that the package leaflet of...
27.The licence holder must keep the data referred to in...
PART 4 Wholesale dealer's licence
All wholesale dealer's licences
28.The provisions of this Part are standard provisions of a...
29.The licence holder must not use any premises for the...
30.The licence holder must provide such information as may be...
31.The licence holder must take all reasonable precautions and exercise...
Wholesale dealer's licence relating to special medicinal products
32.The provisions of paragraphs 33 to 42 are incorporated as...
33.Where and in so far as the licence relates to...
33A.A licence holder may only import EAMS medicinal products if...
34.No later than 28 days prior to each importation of...
35.The licence holder may not import the special medicinal product...
36.The licence holder may import the special medicinal product referred...
37.Where the licence holder sells or supplies special medicinal products...
38.The licence holder must not, on any one occasion, import...
39.The licence holder must inform the licensing authority immediately of...
40.The licence holder must not publish any advertisement, catalogue, or...
41.The licence holder must cease importing or supplying a special...
41A.A licence holder— (a) in Great Britain may only supply...
42.In this Part— “British approved name” means the name which...
Wholesale dealer's licence relating to exempt advanced therapy medicinal products
43.The provisions of paragraph 44 are incorporated as additional standard...
44.The licence holder shall keep the data referred to in...
SCHEDULE 5
Review upon oral representations
Application of this Schedule
1.(1) This Schedule applies if a person (“the applicant”) mentioned...
Appointment of reviewers
2.(1) The licensing authority must— (a) appoint a panel of...
Procedure before hearing
3.(1) The applicant must supply the reviewers with a written...
Procedure at hearing
4.(1) Both the applicant and the licensing authority may make...
Procedure following hearing
5.(1) After the hearing the reviewers must provide a report...
SCHEDULE 6
Manufacturer's and wholesale dealer's licences for exempt advanced therapy medicinal products
PART 1 Manufacturer's licences
1.The requirements in paragraphs 2 to 12 apply to a...
2.The licence holder must inform the licensing authority of any...
3.The licence holder must ensure, if using human cells or...
4.The licence holder must ensure that any human tissue or...
5.The licence holder must ensure that any blood or blood...
6.Where the holder of a manufacturer's licence distributes by way...
7.The licence holder must, at the written request of the...
8.The licence holder must establish and maintain a system ensuring...
9.The licence holder must, subject to paragraph 27 of Schedule...
10.The licence holder must secure that the data referred to...
11.The licence holder must, where an exempt advanced therapy medicinal...
12.The licence holder must not import or export any exempt...
PART 2 Wholesale dealer's licences
13.The requirements in paragraphs 14 to 20 apply to a...
14.The licence holder must obtain supplies of exempt advanced therapy...
15.The licence holder must distribute an exempt advanced therapy medicinal...
16.The licence holder must establish and maintain a system ensuring...
17.The licence holder must inform the licensing authority of any...
18.The licence holder must, subject to paragraph 44 of Schedule...
19.The licence holder must secure that the data referred to...
20.The licence holder must not import or export any exempt...
SCHEDULE 7
Qualified persons
PART 1 Qualification requirements for qualified person
1.A person must satisfy the requirements in paragraphs 2 and...
2.The person must have a degree, diploma or other formal...
3.A qualification satisfies the requirements of this Part if it...
4.(1) A course should include at least the following core...
5.If the course referred to in paragraph 3 is followed...
6.If two university courses, or courses recognised as of university...
7.If the person's formal qualifications do not satisfy the requirements...
8.(1) The person must (subject to sub-paragraph (2)) have at...
PART 2 Qualified persons with long experience
9.(1) This paragraph applies to a person who has acted...
10.(1) This paragraph applies to a person who—
11.If a person to whom paragraph 10 applies acquired the...
PART 3 Obligations of qualified person
12.(1) In Great Britain, the qualified person is responsible for...
12A.(1) In Northern Ireland, the qualified person is responsible for...
13.(1) This paragraph applies in Northern Ireland where—
14.(1) This paragraph applies where— (a) medicinal products are imported...
15.(1) The qualified person is responsible for ensuring, in relation...
SCHEDULE 7A
Information to be provided for registration as an importer, manufacturer or distributor of active substances
1.The name and address of the applicant.
2.The name and address of the person (if any) making...
3.The address of each of the premises where any operations...
4.The address of any premises not mentioned by virtue of...
5.The address of each of the premises where active substances...
6.The address of each of the premises where any testing...
7.The name, address, qualifications and experience of the person whose...
8.The name, address, qualifications and experience of the person who...
9.The name, address, qualifications and experience of the person whose...
10.The name, address and qualifications of the person to be...
11.The name, address and qualifications of the person to be...
12.For each active substance to be manufactured, imported, or distributed—...
13.Details of the operations to which the registration relates, including...
14.A statement of the facilities and equipment available at each...
15.A statement as to whether the particular active substances are...
16.A separate statement in respect of each of the premises...
17.A statement of the authority conferred on the person responsible...
18.A description of the arrangements for the identification and storage...
19.A description of the arrangements for the identification and storage...
20.A description of the arrangements at each of the premises...
21.A description of the arrangements for maintaining—
22.A description of the arrangements for keeping reference samples of—...
23.Where the application relates to active substances intended for use...
24.Details of— (a) any manufacturing, importation, storage or distribution operations,...
SCHEDULE 8
Material to accompany an application for a UK marketing authorisation
PART 1 General requirements
1.The name or corporate name and permanent address of the...
2.The name of the medicinal product. This may be—
3.Qualitative and quantitative particulars of the constituents of the medicinal...
4.An evaluation of the potential environmental risks posed by the...
5.A description of the methods of manufacturing the medicinal product....
6.The therapeutic indications and contra-indications for the medicinal product and...
7.The posology and pharmaceutical form of the medicinal product, its...
8.The reasons for any precautionary and safety measures to be...
9.A description of the control methods employed by the manufacturer....
9A.A written confirmation that the manufacturer of the medicinal product...
10.The results of the following in relation to the medicinal...
11.A detailed summary of those results prepared and signed by...
12.A summary of the applicant's pharmacovigilance system which shall include...
13.The risk management plan, together with a summary, that—
14.Where any clinical trials have been carried out outside the...
15.A summary of the product characteristics for the medicinal product...
16.A mock-up, in accordance with Part 13 (packaging and leaflets)...
17.A document showing that the manufacturer of the medicinal product...
18.Where— (a) in the case of a UKMA(NI) or a...
19.Where an authorisation for the medicinal product to be placed...
20.Where , in the case of a medicinal product for...
21.Where an authorisation for the medicinal product to be placed...
22.In the case of a medicinal product for sale or...
PART 2 Summary of the product characteristics
23.For medicinal products included on the list referred to—
24.The name of the medicinal product followed by its strength...
25.The qualitative and quantitative composition, using the usual common name...
25A.In the case of an advanced therapy medicinal product for...
26.The pharmaceutical form of the medicinal product.
27.Clinical particulars in relation to the medicinal product, covering—
28.The pharmacological properties of the medicinal product, covering—
29.Pharmaceutical particulars in relation to the medicinal product, covering—
30.The holder of the UK marketing authorisation.
31.The number of the UK marketing authorisation.
32.The date of the first UK marketing authorisation or, where...
33.The date of any revisions of the text of the...
34.For radiopharmaceuticals, full details of internal radiation dosimetry.
35.For radiopharmaceuticals, additional detailed instructions for extemporaneous preparation and quality...
36.In the case of an advanced therapy medicinal product for...
SCHEDULE 8A
Material to accompany an application for a parallel import licence
1.The name or corporate name and permanent address of the...
2.The name of the medicinal product. This may be—
3.Details of the product to be imported if requested by...
4.Details of the UK reference product.
5.If requested by the licensing authority, an evaluation of the...
6.If requested by the licensing authority, a summary of the...
7.If requested by the licensing authority, the risk management plan,...
8.If requested by the licensing authority, a summary of the...
9.A mock-up, in accordance with Part 13 (packaging and leaflets)...
SCHEDULE 8B
Modifications of Annex I to the 2001 Directive
SCHEDULE 8C
Material to accompany an application for a UK marketing authorisation under the unfettered access route
1.A copy of the application submitted in connection with the...
2.A copy of all material submitted in support of the...
3.A copy of the EU marketing authorisation or UKMA(NI) which...
SCHEDULE 9
Undertakings by non- United Kingdom manufacturers
1.The manufacturer must provide and maintain such staff, premises and...
2.The manufacturer must provide and maintain such staff, premises, equipment...
3.The manufacturer must provide and maintain a designated quality control...
4.The manufacturer must conduct all manufacture and assembly operations in...
5.The manufacturer must maintain an effective pharmaceutical quality assurance system...
6.Where animals are used in the production of any medicinal...
7.The manufacturer must make such adequate and suitable arrangements as...
8.The manufacturer must inform the holder of the UK marketing...
9.(1) The manufacturer shall keep readily available for inspection by...
10.The manufacturer must keep readily available for examination by a...
11.(1) The manufacturer must implement a system for recording and...
12.The manufacturer must inform the holder of the UK marketing...
SCHEDULE 9A
Meaning of terms used in the orphan criteria and in regulation 58D
1.Prevalence of a condition in Great Britain
2.Potential for return on investment
3.Existence of other methods of diagnosis, prevention or treatment
4.Increased safety or effectiveness and clinical superiority
5.(1) This paragraph applies for the purposes of the definition...
6.(1) This paragraph applies for the purposes of the definition...
7.(1) This paragraph applies for the purposes of the definition...
8.(1) This paragraph applies for the purposes of the definition...
SCHEDULE 10
National homoeopathic products
Meaning of “national homoeopathic product”
1.(1) In this Schedule “national homoeopathic product” means a homoeopathic...
General requirements for application
2.(1) An application for the grant of a UK marketing...
Requirement to submit safety data
3.(1) The applicant must submit data as to the safety...
Exceptions to requirement to submit safety data
4.(1) The applicant does not need to submit data as...
Requirement to submit efficacy data
5.(1) The applicant must submit data as to the efficacy...
SCHEDULE 10A
Variations to a UK marketing authorisation
1.Interpretation
2.Classification of variations
3.Licensing authority recommendation on unclassified variations
4.Variations leading to the revision of product information
5.Grouping of variations
6.Notification procedure for minor variations of type IA
7.Notification procedure for minor variations of type IB
8.Prior approval procedure for major variations of type II
9.Elements to be submitted
10.Measures to close the procedures specified in paragraphs 6 to 8
11.Extensions of marketing authorisations
12.Human influenza vaccines
13.Pandemic situation with respect to human influenza
14.Urgent safety restrictions
15.Amendments to the decision granting the marketing authorisation
16.Implementation of variations
17.Continuous monitoring
SCHEDULE 11
Advice and representations
PART 1 General procedures
Application of this Part
1.(1) This Part of this Schedule applies to—
Requirement to consult the appropriate committee
2.(1) The licensing authority must consult the appropriate committee if...
Exceptions to requirement to consult
3.(1) Paragraph 2 does not apply to a proposal to...
4.(1) Paragraph 2 does not apply to a proposal to...
Provisional opinion against authorisation
5.(1) If the appropriate committee is consulted under paragraph 2(1)...
Opportunity to make representations
6.(1) An applicant or holder notified under paragraph 5 may,...
Written representations
7.(1) If the applicant or holder requests the opportunity to...
Oral representations
8.(1) If the applicant or holder requests the opportunity to...
Other decisions of the appropriate committee
9.(1) This paragraph applies if the applicant or holder—
Decision of licensing authority
10.(1) After receiving the appropriate committee's report under paragraph 7...
Right to review after paragraph 10 notification
11.(1) A person to whom a notification is given under...
Licensing authority decisions in other cases
12.(1) This paragraph applies if the appropriate committee has not...
Right to review or representations after paragraph 12 notification
13.(1) A person to whom a notification is given under...
PART 1A Paediatric Decisions
13A.Application of this Part
13B.Opportunity to make representations
13C.Written representations
13D.Oral representations
13E.Other decisions of the appropriate committee
13F.Decision of licensing authority
13G.Right to review after paragraph 13F notification
PART 2 Type II variation applications, complex variation applications and new excipient variation applications
Application of this Part
14.This Part applies— (a) to an application (a “Type II...
15.(1) In paragraph 14(b)(i) “complex variation application” means an application...
16.(1) In paragraph 14(b)(ii) “new excipient variation application” means an...
17.In relation to an application for a UKMA(NI) or THR(NI),...
Opportunity to make representations
18.(1) This paragraph applies if the licensing authority notifies the...
Written representations
19.(1) If the applicant requests the opportunity to make written...
Oral representations
20.(1) If the applicant requests the opportunity to make oral...
Other decisions of the appropriate committee
21.(1) This paragraph applies if the applicant—
Decision of licensing authority following report
22.(1) After receiving the appropriate committee's report under paragraph 19...
Right to review after paragraph 22 notification
23.(1) This paragraph applies if the licensing authority notifies the...
PART 3 Referral to the appropriate committee for traditional herbal registrations
Application of this Part
24.(1) This Part applies if the licensing authority proposes to...
Opportunity to make representations
25.(1) The licensing authority must notify the applicant of the...
Written representations
26.(1) If the applicant requests the opportunity to make written...
Oral representations
27.(1) If the applicant requests the opportunity to make oral...
Other decisions of the appropriate committee
28.(1) This paragraph applies if the applicant—
Decision of licensing authority following report
29.(1) After receiving the appropriate committee's report under paragraph 26...
Right to review after paragraph 29 notification
30.(1) This paragraph applies if the licensing authority notifies the...
PART 4 Exceptions to Schedule
31.This Schedule does not apply to an application for the...
32.This Schedule does not apply to an application for the...
33.This Schedule ceases to apply if at any time the...
34.This Schedule does not apply to an application for a...
35.This Schedule does not apply to an application for a...
36.This Schedule does not apply if the application or proposal...
37.This Schedule does not apply if the application or proposal...
38.This Schedule does not apply if the application or proposal...
39.This Schedule does not apply if— (a) the licensing authority...
SCHEDULE 12
Material to accompany an application for a traditional herbal registration
PART 1 General requirements
1.The name or corporate name and permanent address of the...
2.The name of the medicinal product. This may be—
3.Qualitative and quantitative particulars of the constituents of the medicinal...
4.An evaluation of the potential environmental risks posed by the...
5.A description of the methods of manufacturing the medicinal product....
6.The therapeutic indications and contra-indications for the medicinal product and...
7.The posology and pharmaceutical form of the medicinal product, its...
8.The reasons for any precautionary and safety measures to be...
9.A description of the control methods employed by the manufacturer....
10.Results of pre-clinical (toxicological and pharmacological) tests in relation to...
11.A detailed summary of those results prepared and signed by...
12.A summary of the product characteristics for the medicinal product...
13.A mock-up, in accordance with Part 13 (packaging and leaflets)...
14.A document showing that the manufacturer of the medicinal product...
15.Where the medicinal product consists of a combination of one...
16.Details of any authorisation or registration obtained by the applicant...
17.Details of any decision in a country other than the...
18.Bibliographical or expert evidence of the traditional use of the...
19.A bibliographic review of safety data.
20.An expert report on safety.
PART 2 Summary of the product characteristics
21.For medicinal products included on the list referred to in...
22.The name of the medicinal product followed by its strength...
23.The qualitative and quantitative composition, using the usual common name...
24.The pharmaceutical form of the medicinal product.
25.The pharmacological properties of the medicinal product, covering—
26.Pharmaceutical particulars of the medicinal product, covering—
27.The holder of the traditional herbal registration.
28.The number of the traditional herbal registration.
29.The date of the first traditional herbal registration or, where...
30.The date of any revisions of the text of the...
SCHEDULE 12A
Further provision as to the performance of pharmacovigilance activities
PART 1 Pharmacovigilance system master file
1.Structure of the pharmacovigilance system master file
2.Content of the pharmacovigilance system master file
3.Content of the Annex to the pharmacovigilance system master file
4.Maintenance of the pharmacovigilance system master file
5.Form of the documents contained in the pharmacovigilance system master file
6.Subcontracting
7.Availability and location of the pharmacovigilance system master file
PART 2 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders
8.Quality system
9.Performance indicators
PART 3 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by holders
10.Management of human resources
11.Compliance management
12.Record management and data retention
13.Audit
PART 4 Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority
14.Management of human resources
15.Compliance management
16.Record management and data retention
17.Audit
PART 5 Use of terminology, formats and standards
18.Use of internationally agreed terminology, formats and standards
PART 6 Transmission of reports of suspected adverse reactions
19.Individual case safety reports
20.Content of the individual case safety report
21.Format of electronic transmission of suspected adverse reactions
PART 7 Risk management plans
22.Content of the risk management plan
23.Summary of the risk management plan
24.Updates of the risk management plan
25.Format of the risk management plan
PART 8 Periodic safety update reports
26.Content of periodic safety update reports
27.Format of periodic safety update reports
PART 9 Post-authorisation safety studies
28.Scope and interpretation
29.Obligations as to post-authorisation safety studies
30.Format of the study protocol
31.Format of the abstract of the final study report
32.Format of the final study report
SCHEDULE 13
Prescription only medicines for which community practitioner nurse prescribers are appropriate practitioners
Co-danthramer Capsules NPF Co-danthramer Capsules Strong NPF Co-danthramer Oral Suspension...
SCHEDULE 14
Prescription etc by supplementary prescribers: particulars of clinical management plan
A clinical management plan must contain the following particulars—
SCHEDULE 15
Requirements for specific products subject to general sale
1.A medicinal product that contains aloxiprin, aspirin or paracetamol (or,...
2.A medicinal product that contains ibuprofen and that is in...
SCHEDULE 16
Patient group directions
PART 1 Particulars to be included in a patient group direction
1.The period during which the direction is to have effect....
2.The description or class of medicinal product to which the...
3.The clinical situations which medicinal products of that description or...
4.Whether there are any restrictions on the quantity of medicinal...
5.The clinical criteria under which a person is to be...
6.Whether any class of person is excluded from treatment under...
7.Whether there are circumstances in which further advice should be...
8.The pharmaceutical form or forms in which medicinal products of...
9.The strength, or maximum strength, at which medicinal products of...
10.The applicable dosage or maximum dosage.
11.The route of administration.
12.The frequency of administration.
13.Any minimum or maximum period of administration applicable to medicinal...
14.Whether there are any relevant warnings to note and, if...
15.Whether there is any follow up action to be taken...
16.Arrangements for referral for medical advice.
17.Details of the records to be kept of the supply,...
PART 2 Persons on whose behalf a patient group Direction must be signed
PART 3 Persons by whom or on whose behalf a patient group direction used as described in regulation 234 must be signed
PART 4 Classes of individuals by whom supplies may be made
Pharmacists. Registered chiropodists and podiatrists. Registered dental hygienist. Registered dental...
SCHEDULE 17
Exemption for sale, supply or administration by certain persons
PART 1 Exemption from restrictions on sale and supply of prescription only medicines
PART 2 Exemption from the restriction on supply of prescription only medicines
PART 3 Exemptions from the restriction on administration of prescription only medicines
PART 4 Exemptions from the restrictions in regulations 220 and 221 for certain persons who sell, supply, or offer for sale or supply certain medicinal products
PART 5 Exemptions from the restrictions in regulations 220 and 221 for certain persons who supply certain medicinal products
SCHEDULE 18
Substances that may not be sold or supplied by a pharmacist without a prescription in reliance on regulation 225
Ammonium bromide Calcium bromide Calcium bromidolactobionate Embutramide Fencamfamin hydrochloride Fluanisone...
SCHEDULE 19
Medicinal products for parenteral administration in an emergency
Adrenaline 1:1000 up to 1mg for intramuscular use in anaphylaxis...
SCHEDULE 20
Herbal medicinal products specified for the purposes of regulation 241
PART 1
PART 2
SCHEDULE 21
Medicinal products at high dilutions
PART 1 Dilutions of unit preparations diluted to at least one part in a thousand (3x)
PART 2 Dilutions of unit preparations diluted to at least one part in a million (6x)
PART 3 Dilutions of unit preparations diluted to at least one part in ten (1x)
PART 4 Dilutions of unit preparations diluted to at least one part in ten (1x) for external use
SCHEDULE 22
Classes of person for the purposes of regulation 249
Doctors
Dentists
Persons lawfully conducting a retail pharmacy business within the meaning...
Authorities or persons carrying on the business of—
Holders of wholesale dealer's licences or persons to whom the...
Ministers of the Crown and Government departments.
Scottish Ministers.
Welsh Ministers.
A Northern Ireland Minister.
An NHS trust.
An NHS foundation trust.
The Common Services Agency.
A health authority or a special health authority.
. . . . . . . . . ....
A person other than an excepted person who carries on...
A person other than an excepted person who carries on...
In this Schedule “excepted person” means— (a) a doctor or...
SCHEDULE 23
Particulars in pharmacy records
1.Paragraph 2 applies, subject to paragraph 3, where the sale...
2.In such a case, the particulars referred to in regulation...
3.Where the sale or supply is in pursuance of a...
4.Where the sale or supply of a prescription only medicine...
5.Paragraph 6 applies where— (a) the sale or supply of...
6.In such a case, the particulars referred to in regulation...
SCHEDULE 24
Packaging information requirements
PART 1 Outer and immediate packaging
1.The name of the medicinal product.
2.The strength and pharmaceutical form of the product.
3.Where appropriate, whether the product is intended for babies, children...
4.Where the product contains up to three active substances, the...
5.A statement of the active substances in the product, expressed...
6.The pharmaceutical form and the contents by weight, by volume...
7.A list of— (a) where the product is injectable or...
8.The method of administration of the product and if necessary...
9.Where appropriate, space for the prescribed dose to be indicated....
10.A warning that the product must be stored out of...
11.Any special warning applicable to the product.
12.The product's expiry date (month and year), in clear terms....
13.Any special storage precautions relating to the product.
14.Any special precautions relating to the disposal of an unused...
15.The name and address of the holder of the UK...
16.The number of the UK marketing authorisation, EU marketing authorisation...
17.The manufacturer's batch number.
18.In the case of a product that is not a...
18A.In the case of a medicinal product, other than a...
PART 2 Immediate packaging: blister packs
19.The name of the medicinal product.
20.The strength and pharmaceutical form of the product.
21.Where appropriate, whether the product is intended for babies, children...
22.Where the product contains up to three active substances, the...
23.The name of the holder of the UK marketing authorisation,...
24.The product's expiry date (month and year), in clear terms....
25.The manufacturer's batch number.
PART 3 Immediate packaging: small packages
26.The name of the medicinal product.
27.The strength and pharmaceutical form of the product.
28.Where appropriate, whether the product is intended for babies, children...
29.Where the product contains up to three active substances, the...
30.The method of administration of the product and if necessary...
31.The product's expiry date (month and year), in clear terms....
32.The manufacturer's batch number.
33.The contents of the packaging by weight, by volume or...
PART 4 Outer and immediate packaging: advanced therapy medicinal products for sale or supply in Great Britain only
34.The name of the advanced therapy medicinal product which is...
35.Where appropriate, whether the product is intended for babies, children...
36.The expiry date in clear terms including the year and...
37.A description of the active substance, expressed qualitatively and quantitatively....
38.Where the product contains tissues and cells of human or...
39.The pharmaceutical form and the contents by weight, volume or...
40.A list of excipients, including preservative systems.
41.The method of use, application, administration or implantation and, if...
42.A special warning that the product is to be stored...
43.Any special warning necessary for the particular product.
44.Any special storage precautions.
45.Specific precautions relating to the disposal of the unused product...
46.The name and address of the holder of the UK...
47.The UK marketing authorisation number.
48.The manufacturer's batch number.
49.The unique donation code assigned by a tissue establishment pursuant...
50.Where the exempt advanced therapy medicinal product is for autologous...
PART 5 Immediate packaging: blister packs and small packaging (advanced therapy medicinal products for sale or supply in Great Britain only)
51.The information specified in Part 2.
52.The unique donation code assigned by a tissue establishment pursuant...
53.Where the exempt advanced therapy medicinal product is for autologous...
SCHEDULE 25
Packaging requirements: specific provisions
PART 1 Medicines on prescription
1.Where the product is to be administered to a particular...
2.The name and address of the person who sells or...
3.The date on which the product is sold or supplied....
4.Unless paragraph 5, applies, such of the following particulars as...
5.This paragraph applies if the pharmacist, in the exercise of...
6.Where paragraph 5 applies, the pharmacist may include such particulars,...
PART 2 Transport, delivery and storage
7.Any special requirements for the storage and handling of the...
8.The expiry date of the product.
9.The manufacturer's batch number.
PART 3 Pharmacy and prescription only medicines
10.Paragraph 11 applies if a pharmacy medicine is—
11.Where this paragraph applies, the capital letter “P” within a...
12.Paragraph 13 applies if a prescription only medicine is—
13.Where this paragraph applies, the capital letters “POM” within a...
PART 4 Medicines containing paracetamol
14.If the product contains paracetamol, except where the name of...
15.If the product contains paracetamol the words “Do not take...
16.If the product contains paracetamol, unless the product is wholly...
17.If the product contains paracetamol and is wholly or mainly...
18.If the product is required by this Part of this...
SCHEDULE 26
Packaging requirements: special provisions
PART 1 Supply by doctors, dentists, nurses and midwives
1.Where the product is to be administered to a particular...
2.The name and address of the person who sells or...
3.The date on which the product is sold or supplied....
4.Such of the following particulars as the person under whose...
PART 2 Pharmacy exceptions
5.Where the product is to be administered to a particular...
6.The name and address of the person who sells or...
7.The date on which the product is sold or supplied....
8.Where the product is prescribed by an appropriate practitioner, such...
9.This paragraph applies if a pharmacist, in the exercise of...
10.Where paragraph 9 applies, the pharmacist may include such particulars,...
11.Where the product is not prescribed by an appropriate practitioner,...
SCHEDULE 27
Package leaflets
PART 1 General requirements
1.The name of the medicinal product.
2.The strength and pharmaceutical form of the product.
3.Where appropriate, whether the product is intended for babies, children...
4.Where the product contains up to three active substances, the...
5.The pharmaco-therapeutic group, or type of activity, of the product,...
6.The product's therapeutic indications.
7.A list of— (a) contra-indications; (b) appropriate precautions for use;...
8.The list mentioned in paragraph 7 must—
9.Instructions for proper use of the product including in particular—...
10.A description of the adverse reactions which may occur in...
11.A reference to the expiry date printed on the packaging...
12.Where the product is authorised for sale or supply in...
13.For medicinal products included in the list referred to in...
14.A standardised text relating to adverse event reporting in accordance...
15.The date on which the package leaflet was last revised....
PART 2 Paracetamol
16.If a medicinal product contains paracetamol, unless the product is...
17.If a medicinal product contains paracetamol and is wholly or...
Part 3 Advanced therapy medicinal products for sale or supply in Great Britain only
18.The name of the advanced therapy medicinal product.
19.Where appropriate, whether the product is intended for babies, children...
20.The common name of the advanced therapy medicinal product.
21.The therapeutic group, or type of activity, of the product,...
22.Where the product contains cells or tissues, a description of...
23.Where the product contains medical devices or active implantable medical...
24.The product's therapeutic indications.
25.A list of information which is necessary before the medicinal...
26.The list mentioned in paragraph 25 must—
27.Instructions for proper use of the product including in particular—...
28.A description of the adverse reactions which may occur in...
29.A reference to the expiry date printed on the packaging...
30.The date on which the package leaflet was last revised....
SCHEDULE 28
Labelling requirements for registrable homoeopathic medicinal products
PART 1 Outer and immediate packaging
1.The scientific name of the stock or stocks (which may...
2.The name and address of the holder of the certificate...
3.The method and, if necessary, route of administration.
4.The product's expiry date (month and year), in clear terms....
5.The product's pharmaceutical form.
6.The contents of the presentation, specified by weight, volume or...
7.Special storage precautions, if any.
8.A special warning, if necessary in relation to the product....
9.The manufacturer's batch number.
10.The number of the certificate of registration.
11.The words “homoeopathic medicinal product without therapeutic indications”.
12.A warning advising the user to consult a doctor if...
PART 2 Blister packs etc contained in outer packaging
13.The scientific name of the stock or stocks (which may...
14.The name and address of the holder of the certificate...
15.The product's expiry date (month and year), in clear terms....
16.The manufacturer's batch number.
17.The words “homoeopathic medicinal product without therapeutic indications”.
PART 3 Small immediate packaging
18.The scientific name of the stock or stocks (which may...
19.The name and address of the holder of the certificate...
20.The method and, if necessary, route of administration.
21.The product's expiry date (month and year), in clear terms....
22.The contents of the presentation, specified by weight, volume or...
23.The manufacturer's batch number.
24.The words “homoeopathic medicinal product without therapeutic indications”.
SCHEDULE 29
Labelling of traditional herbal medicinal products
PART 1 Traditional herbal medicinal products: general
1.A statement to the effect that the product is a...
2.A statement that the user should consult a doctor or...
PART 2 Traditional herbal medicinal products not subject to general sale
3.Subject to the provisions of regulation 265(2), paragraph 4 applies...
4.Where this paragraph applies, the outer packaging and the immediate...
SCHEDULE 30
Particulars for advertisements to persons qualified to prescribe or supply
1.The number of the UK marketing authorisation, EU marketing authorisation,...
2.The name and address of the holder of the temporary...
2A.In relation to an advertisement in Great Britain (other than...
3.The classification of the medicinal product as—
4.The name of the medicinal product.
5.A list of the active ingredients of the medicinal product...
6.One or more of the indications for the medicinal product...
7.The entries or a succinct statement of the entries (if...
8.The cost excluding value added tax of—
9.(1) The particulars specified in paragraph 7 must be printed...
SCHEDULE 31
Sampling
Introductory
1.(1) This Schedule has effect where a person authorised by...
Division of sample
2.The sampling officer must as soon as practicable—
3.If the sample was purchased by the sampling officer otherwise...
4.If the sampling officer obtained the sample from a vending...
5.If the sample is a sample of goods consigned from...
6.If, in a case not falling within any of paragraphs...
7.If, in a case not falling within any of paragraphs...
8.In any case not falling within any of paragraphs 3...
9.In every case falling within any of paragraphs 3 to...
10.Unless the sampling officer decides not to submit the sample...
11.If a sample consists of substances or articles in unopened...
12.Regulation 343(1)(a) to (d) has effect in relation to supplying...
13.If after reasonable inquiry the sampling officer is unable to...
Notice to person named on container
14.(1) This paragraph applies where the sampling officer has obtained...
Analysis or other examination
15.Where the enforcing authority that authorises the sampling officer is...
16.Where any other enforcing authority authorises the sampling officer, if...
17.(1) Arrangements of the kind mentioned in paragraphs 15(b) and...
18.A laboratory to which a sample is submitted under paragraph...
19.A laboratory that has analysed or examined a sample submitted...
20.A person to whom a part of the sample is...
Provisions as to evidence
21.(1) In proceedings for an offence under these Regulations, a...
22.In proceedings for an offence under these Regulations, a document...
23.(1) If, in proceedings before a magistrates' court for an...
Analysis under direction of court
24.(1) This paragraph applies where proceedings for an offence under...
25.The costs of analysis or examination under paragraph 24 are...
Proof by written statement
26.(1) In relation to England and Wales section 9 of...
Payment for sample taken under compulsory powers
27.(1) Where a sampling officer takes a sample in the...
SCHEDULE 32
Transitional provisions and savings
Continuity of the law
1.(1) This paragraph applies where any provision of these Regulations...
Product licences
2.(1) This paragraph applies to a marketing authorisation that—
Product licences of right
3.(1) This paragraph applies to a product licence of right....
Classification of UK marketing authorisation and certificate of registration
4.(1) Sub-paragraph (3) applies to a UK marketing authorisation granted...
Advanced therapy medicinal products
5.No provision of these Regulations that applies only to advanced...
Medicines for Human Use (Advanced Therapy Medicinal Products and Miscellaneous Amendments) Regulations 2010 (S.I. 2010/1882)
6.Regulation 9 (amendment of the Medicines for Human Use (Clinical...
Section 60 of the Medicines Act 1968 etc
7.(1) Section 60 of the Medicines Act 1968 (“the Act”)...
SCHEDULE 33
Transitional arrangements: pharmacovigilance
1.Pharmacovigilance system master file
2.Regulation 210(3)(b) (offences relating to pharmacovigilance obligations under Regulation (...
3.Post-authorisation safety studies
4.Regulation 210(3)(g) (offences relating to pharmacovigilance obligations under Regulation (EC)...
5.Reporting obligations
6.The references to “the Eudravigilance database” in regulation 188(1)(a) and...
7.The licensing authority must ensure that all reports and updated...
8.Regulations 186(1)(e) (reporting obligations on licensing authority in relation to...
9.Periodic safety update reports
10.The reference to “the EMA” in regulations 191(1) (obligation on...
SCHEDULE 33A
Transitional provision in relation to EU Exit
PART 1 Interpretation
1.In this Schedule— “ the COMP ” means the Committee...
PART 2 Manufacturing, wholesale dealing and brokering
2.Wholesale dealer's licence used to distribute a medicinal product imported from an EEA State before IP completion day
3.Approved country for import list on IP completion day (regulation 18A)
4.Qualified persons and approved country for batch testing list on IP completion day (Schedule 7)
5.List of countries with equivalent regulatory standards as to the manufacturing of active substances on IP completion day (regulation 45O(6) to (9))
PART 3 Transitional provision in respect of conversion of EU marketing authorisations in force immediately before IP completion day
6.Conversion of EU marketing authorisations in force before IP completion day
7.Classification of converted EU marketing authorisations
8.Obligations of licensing authority in connection with converted EU marketing authorisations
9.Obligations of holders of converted EU marketing authorisations
10.Powers of licensing authority in connection with provision of information
11.Variations of converted EU marketing authorisations notified or applied for before IP completion day
12.Variations of converted EU marketing authorisations submitted to EMA after IP completion day but before the data submission date
13.Variations of converted EU marketing authorisations sought in advance of the data submission date
14.Applications for renewals of converted EU marketing authorisations made before IP completion day
15.Applications for renewals of conditional marketing authorisations made before IP completion day
16.Applications for renewals of converted EU marketing authorisations made after IP completion day
17.Applications for renewals of conditional marketing authorisations made after IP completion day
18.Renewals of converted EU marketing authorisations sought in advance of the data submission date
19.Article 61(3) notifications made before IP completion day in relation to converted EU marketing authorisations
20.Article 61(3) notifications made in relation to converted EU marketing authorisations after IP completion day but before the data submission date
21.Article 61(3) notifications sought in advance of the data submission date
22.Place of establishment for converted EU marketing authorisation holder established in EEA state before IP completion day
23.Temporary exemption as to packaging requirements for converted EU marketing authorisations
24.Referrals made under Article 20 of Regulation (EC) No 726/2004 that have not concluded or been implemented before IP completion day
25.Enforcement
PART 4 Transitional provision in respect of UK marketing authorisations, parallel import licences and parallel distribution notices
26ZA. Status of certain UK marketing authorisations granted before IP completion day
26.Place of establishment for UK marketing authorisation holder or parallel import licence holder established in an EEA State before IP completion day
27.Temporary exemption as to packaging requirements: change of place of establishment
27A. Status of parallel import licences granted before IP completion day
28.Conversion of parallel distribution notices in to parallel import licences
29.Inclusion of the batch testing condition in relevant UK marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60A)
29A. Application of the batch testing requirement to relevant EU marketing authorisations, and batch testing of biological medicinal products in the EEA before IP completion day (regulation 60B)
30.Existing data and marketing exclusivity and global marketing authorisations
31.Applications for EU marketing authorisations made before IP completion day
32.Place of establishment for UK marketing authorisation holder established in EEA state before IP completion day (pre-exit EU marketing authorisation applications)
33.Packaging in relation to UK marketing authorisations granted in response to application for EU marketing authorisation made before IP completion day
34.Applications made for a UK marketing authorisation before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
35.Transitional provision in respect of Plasma Master Files
36.Suspensions of UK marketing authorisations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive or Regulation (EC) No 726/2004
37.Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of an EU marketing authorisation or a UK marketing authorisation that have not concluded before IP completion day
PART 5 Transitional provision in relation to variations of marketing authorisations other than converted EU marketing authorisations
38.Application or notification made before IP completion day in respect of a variation under Chapter IIa of Regulation (EC) No 1234/2008 (variations to purely national marketing authorisations)
39.Application or notification made before IP completion day in respect of a variation under Chapter II of Regulation (EC) No 1234/2008 (variations to marketing authorisations granted in accordance with Chapter 4 of the 2001 Directive)
40.Application or notification in respect of a variations made before IP completion day under Article 20 of Regulation (EC) No 1234/2008 (work-sharing procedure)
PART 6 Transitional provision in relation to the Paediatric Regulation
41.Transitional provision in relation to applications made to EMA before IP completion day under the Paediatric Regulation
41A. Transitional provision in relation to global marketing authorisations under the 2001 Directive
PART 8 Transitional provision in respect of homoeopathic medicinal products
43.List of countries for the purposes of the definition of “homoeopathic medicinal product” on IP completion day
44.Place of establishment for holders of certificates of registration established in EEA before IP completion day
45.Temporary exemption as to packaging requirements: change of place of establishment
46.Applications made for a certificate of registration for a registrable homoeopathic product before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
47.Suspensions of certificates of registration that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive
48.Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a certificate of registration that have not concluded before IP completion day
PART 9 Transitional provision in respect of traditional herbal registrations
49.Place of establishment for holders of traditional herbal registrations established in EEA before IP completion day
50.Temporary exemption as to packaging requirements: change of place of establishment
51.List of approved countries for traditional use of a herbal medicinal product on IP completion day
52.Applications made for a traditional herbal registration before IP completion day to which Chapter 4 of Title III of the 2001 Directive applied
53.Suspensions of traditional herbal registrations that have effect immediately before IP completion day that were imposed under Chapter 4 of Title III of the 2001 Directive
54.Referrals made under Article 31 of the 2001 Directive concerning the suspension, variation or revocation of a traditional herbal registration that have not concluded before IP completion day
55.Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day
PART 10 Transitional provision in respect of pharmacovigilance
58.Referrals made under Article 107i of the 2001 Directive concerning the evaluation of data from pharmacovigilance activities which are not concluded before IP completion day
59.Matters on-going at IP completion day in respect of periodic safety update reports
60.Matters on-going at IP completion day in relation to draft study protocols under Article 107n and 107o of the 2001 Directive (submission of, and amendment to, draft study protocols for required studies)
61.Matters on-going at IP completion day in respect of the follow up of final study reports
PART 11 Transitional provision in respect of Part 12
62.Approved country health professional list on IP completion day (regulation 214(6A))
PART 12 General provision in relation to transitional provisions
63.Licensing authority power to require information
SCHEDULE 34
Amendments to existing law
PART 1 The Medicines Acts 1968 and 1971
1.The Medicines Act 1968 is amended as follows.
2.For the text of section 1 (Ministers responsible for the...
3.In section 10 (exemptions for pharmacists)— (a) in subsection (1)...
4.In section 15 (provision for extending or modifying exemptions)—
5.In section 58 (medicinal products on prescription only)—
6.In section 58A(1) (requirement to specify certain products as prescription-only...
7.In section 62 (prohibition of sale or supply, or importation,...
8.In section 64(5) (protection for purchasers of medicinal products) for...
9.(1) Section 67 (offences under Part III) is amended as...
10.In section 72 (representative of pharmacist in case of death...
11.In section 82(4) (pharmacies: procedure relating to disqualification) for “Pharmaceutical...
12.In section 87 (requirements as to containers)—
13.In section 88(1) (distinctive colours, shapes and markings of medicinal...
14.In section 91 (offences under Part V, and supplementary provisions)—...
15.In section 104 (application of Act to certain articles and...
16.In section 105 (application of Act to certain other substances...
17.In section 107 (validity of decisions and proceedings relating thereto)—...
18.(1) Section 108 (enforcement in England and Wales) is amended...
19.In section 109 (enforcement in Scotland)— (a) in subsection (2)—...
20.In section 110 (enforcement in Northern Ireland)—
21.In section 111 (rights of entry)— (a) in subsection (1)...
22.In section 113(1) (application of sampling procedure to substance or...
23.In section 114(1) (supplementary provisions as to rights of entry...
24.In section 121(4) (contravention due to default of other person),...
25.In section 122(2) (warranty as defence), for the words “section...
26.In section 123(1)(b) (offences in relation to warranties and certificates...
27.In section 125 (prosecutions)— (a) in subsection (4)—
28.In section 126 (presumptions)— (a) in subsection (1), omit paragraph...
29.In section 128 (financial provisions)— (a) in subsection (1), for...
30.In section 129 (orders and regulations)— (a) in subsection (2),...
31.In section 130 (meaning of medicinal product and related expressions)—...
32.In section 131(5) (meaning of “wholesale dealing”, “retail sale” and...
33.In section 132 (general interpretation provisions)— (a) for subsection (1)...
34.In Schedule 3 (sampling)— (a) omit paragraphs 5 to 7;...
35.In Schedule 4 (provisions relating to Northern Ireland)—
Medicines Act 1971
36.(1) The Medicines Act 1971 shall have effect as follows....
PART 2 Other primary legislation
Trade Descriptions Act 1968
37.In section 2(5)(b) (trade descriptions) of the Trade Descriptions Act...
House of Commons Disqualification Act 1975
38.In Part II (bodies of which all members are disqualified)...
Northern Ireland Assembly Disqualification Act 1975
39.In Part II (bodies of which all members are disqualified)...
Consumer Protection Act 1987
40.Section 19(1) (interpretation of Part II) of the Consumer Protection...
Environmental Protection Act 1990
41.In section 142(7) (powers to obtain information about potentially hazardous...
Value Added Tax Act 1994
42.In Part II of Schedule 8 (zero-rating) to the Value...
Health Act 1999
43.In section 60(2A)(c) (regulation of health care and associated professions)...
Communications Act 2003
44.In section 368R(1) (interpretation of Part 4A) of the Communications...
Christmas Day and New Year's Day Trading (Scotland) Act 2007
45.In section 7 (interpretation) of the Christmas Day and New...
PART 3 Northern Ireland Orders in Council
Health and Personal Social Services (Northern Ireland) Order 1972
46.The Health and Personal Social Services (Northern Ireland) Order 1972...
Pharmacy (Northern Ireland) Order 1976
47.In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...
Poisons (Northern Ireland) Order 1976
48.In article 2(2) of the Pharmacy (Northern Ireland) Order 1976...
Diseases of Animals (Northern Ireland) Order 1981
49.In article 38 of the Diseases of Animals (Northern Ireland)...
Waste and Contaminated Land (Northern Ireland) Order 1997
50.In article 33(6) of the Waste and Contaminated Land (Northern...
Shops (Sunday Trading &c.) (Northern Ireland) Order 1997
51.In article 4(3) of the Shops (Sunday Trading &c.) (Northern...
PART 4 The Medicines for Human Use (Clinical Trials) Regulations 2004
52.The Medicines for Human Use (Clinical Trials) Regulations 2004 are...
53.In regulation 2(1) (interpretation)— (a) before the definition “the Act”...
54.In regulation 4(3) (responsibility for functions under the Directive) for...
55.In regulation 19(10) (authorisation procedure for clinical trials involving medicinal...
56.In regulation 46(2)(c) (labelling) for words from “Schedule 5” to...
57.In regulation 47 (application of enforcement provisions of the Act)—...
58.In regulation 48(5) (infringement notices) for “sections 108 to 110...
59.In regulation 49(5) (offences) for “the Act” substitute “ the...
60.In regulation 53(3) (construction of references to specified publications) for...
61.In paragraph 4(2) of Schedule 5 (procedural provisions relating to...
62.In Schedule 7 (standard provisions for manufacturing authorisations)—
63.In paragraph 5(2) of Schedule 8 (procedural provisions relating to...
64.For Schedule 9 substitute the following Schedule— SCHEDULE 9 MODIFICATIONS OF...
PART 5 Other United Kingdom, Scotland and Wales Secondary legislation
Medicines (Administration of Radioactive Substances) Regulations 1978
65.In regulation 8(1) of the Medicines (Administration of Radioactive Substances)...
Importation of Animal Products and Poultry Products Order 1980
66.In the Schedule to the Importation of Animal Products and...
Medicines Act (Hearings by Persons Appointed) (Scotland) Rules 1986
67.In rule 2 of The Medicines Act (Hearings by Persons...
Medicines Act (Hearings by Persons Appointed) Rules 1986
68.In rule 2 of The Medicines Act (Hearings by Persons...
Medicines (Fixing of Fees Relating to Medicinal Products for Human Use) Order 1989
69.(1) The Medicines (Fixing of Fees Relating to Medicinal Products...
Medical Devices (Consultation Requirements) (Fees) Regulations 1995
70.In regulation 1(2) of the Medical Devices (Consultation Requirements) (Fees)...
Prescription Only Medicines (Human Use) Order 1997
71.(1) The Prescription Only Medicines (Human Use) Order 1997 is...
General Optical Council (Rules relating to Injury or Disease of the Eye) Order of Council 1999
72.In rule 7B(b) of the Schedule to the General Optical...
National Health Service (Charges for Drugs and Appliances) Regulations 2000
73.The National Health Service (Charges for Drugs and Appliances) Regulations...
Biocidal Products Regulations 2001
74.In Schedule 2 to the Biocidal Products Regulations 2001 —...
Medicines (Aristolochia and Mu Tong etc) (Prohibition Order) 2001
75.In article 4(4) of the Medicines (Aristolochia and Mu Tong...
Misuse of Drugs Regulations 2001
76.In regulation 2(1) of the Misuse of Drugs Regulations 2001...
Medicines for Human Use (Kava-kava) (Prohibition Order) 2002
77.In paragraph (d) of article 3 of the Medicines for...
Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003
78.In article 1(3) of the Medicines and Healthcare Products Regulatory...
Enterprise Act 2002 (Part 8 Community Infringements Specified UK Laws) Order 2003
79.In the column “specified UK laws” of the Schedule to...
Enterprise Act 2002 (Part 8 Notice to OFT of Intended Prosecution Specified Enactments, Revocation and Transitional Provision) Order 2003
80.In the Schedule to the Enterprise Act 2002 (Part 8...
Health Professions (Parts of and Entries in the Register) Order of Council 2003
81.In article 6 of the Health Professions (Parts of and...
Unlicensed Medicinal Products for Human Use (Transmissible Spongiform Encephalopathies) (Safety) Regulations 2003
82.(1) The Unlicensed Medicinal Products for Human Use (Transmissible Spongiform...
National Health Service (General Medical Services Contracts) (Scotland) Regulations 2004
83.(1) The National Health Service (General Medical Services Contracts) (Scotland)...
National Health Service (Primary Medical Services Section 17C Agreements) (Scotland) Regulations 2004
84.(1) The National Health Service (Primary Medical Services Section 17C...
National Health Service (General Medical Services Contracts) Regulations 2004
85.(1) The National Health Service (General Medical Services Contracts) Regulations...
National Health Service (General Medical Services Contracts) (Wales) Regulations 2004
86.(1) The National Health Service (General Medical Services Contracts) (Wales)...
National Health Service (Personal Medical Services Agreements) Regulations 2004
87.(1) The National Health Service (Personal Medical Services Agreements) Regulations...
National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004
88.In Schedule 2 to the National Health Service (General Medical...
Contracting Out (Functions relating to Broadcast Advertising) and Specification of Relevant Functions Order 2004
89.(1) The Contracting Out (Functions relating to Broadcast Advertising) and...
General Optical Council (Registration Rules) Order of Council 2005
90.In the Table in rule 10 of the Schedule to...
National Health Service (Free Prescriptions and Charges for Drugs and Appliances) (Wales) Regulations 2007
91.(1) The National Health Service (Free Prescriptions and Charges for...
Human Tissue (Quality and Safety for Human Application) Regulations 2007
92.In regulation 2(3) of the Human Tissue (Quality and Safety...
Legislative and Regulatory Reform (Regulatory Functions) Order 2007
93.(1) The Schedule to the Legislative and Regulatory Reform (Regulatory...
Medicines for Human Use (Prohibition) (Senecio and Miscellaneous Amendments) Order 2008
94.In paragraph (d) of article 3 of the Medicines for...
Specified Animal Pathogens Order 2008
95.In article 5(2) of the Specified Animal Pathogens Order 2008...
Specified Animal Pathogens (Wales) Order 2008
96.In article 5(2) of the Specified Animal Pathogens (Wales) Order...
Health Service Branded Medicines (Control of Prices and Supply of Information) (No 2) Regulations 2008
97.In regulation 1(2) of the Health Service Branded Medicines (Control...
Specified Animal Pathogens (Scotland) Order 2009
98.In article 5(2) of the Specified Animal Pathogens (Scotland) Order...
National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009
99.(1) The National Health Service (Pharmaceutical Services) (Scotland) Regulations 2009...
Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland and Northern Ireland) Order 2009
100.(1) The Co-ordination of Regulatory Enforcement (Regulatory Functions in Scotland...
Single Use Carrier Bags Charge (Wales) Regulations 2010
101.In Schedule 1(3) to the Single Use Carrier Bags Charge...
PART 6 Northern Ireland statutory rules
Control of Pesticides Regulations (Northern Ireland) 1987
102.For regulation 3(2)(b)(i) of the Control of Pesticides Regulations (Northern...
Prison and Young Offenders Centre (Amendment) Rules (Northern Ireland) 1995
103.In rule 4 of the Prison and Young Offenders Centre...
Diseases of Animals (Importation of Bird Products) Order (Northern Ireland) 1996
104.In the Schedule to the Diseases of Animals (Importation of...
Pharmaceutical Services Regulations (Northern Ireland) 1997
105.In Part 2 of Schedule 2 to the Pharmaceutical Services...
Industrial Pollution Control (Prescribed Processes and Substances) Regulations (Northern Ireland) 1998
106.In Schedule 1, Chapter 4, Section 4.8, Part C of...
Products of Animal Origin (Import and Export) Regulations (Northern Ireland) 1998
107.The Products of Animal Origin (Import and Export) Regulations (Northern...
Importation of Animal Pathogens Order (Northern Ireland) 1999
108.In article 5(a) of the Importation of Animal Pathogens Order...
Biocidal Products Regulations (Northern Ireland) 2001
109.In Schedule 2 to the Biocidal Products Regulations (Northern Ireland)...
Misuse of Drugs Regulations (Northern Ireland) 2002
110.(1) The Misuse of Drugs Regulations (Northern Ireland) 2002 are...
Control of Substances Hazardous to Health Regulations (Northern Ireland) 2003
111.In regulation 5(2)(c) of the Control of Substances Hazardous to...
Waste Management Licensing Regulations (Northern Ireland) 2003
112.In paragraph 2 of Schedule 1 to the Waste Management...
Health and Personal Social Services (General Medical Services Contracts) Regulations (Northern Ireland) 2004
113.(1) The Health and Personal Social Services (General Medical Services...
Nursing Homes Regulations (Northern Ireland) 2005
114.In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...
Residential Care Homes Regulations (Northern Ireland) 2005
115.In regulation 13(6)(b) of the Nursing Homes Regulations (Northern Ireland)...
Children's Homes Regulations (Northern Ireland) 2005
116.In regulation 20(4)(b) of the Children's Homes Regulations (Northern Ireland)...
Healthy Start Scheme and Day Care Food Scheme Regulations (Northern Ireland) 2006
117.In regulation 3(1) of the Healthy Start Scheme and Day...
Avian Influenza and Influenza of Avian Origin in Mammals Regulations (Northern Ireland) 2007
118.In regulation 71(3)(a) of the Avian Influenza and Influenza of...
Day Care Setting Regulations (Northern Ireland) 2007
119.In regulation 13(6)(b) of the Day Care Setting Regulations (Northern...
Residential Family Centres Regulations (Northern Ireland) 2007
120.In regulation 13(4)(b) of the Residential Family Centres Regulations (Northern...
Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2007
121.In regulation 3(1)(a) of the Natural Mineral Water, Spring Water...
Specified Animal Pathogens Order (Northern Ireland) 2008
122.In article 5(2)(b) of the Specified Animal Pathogens Order (Northern...
Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009
123.In regulation 2(2) of the Controlled Drugs (Supervision of Management...
Private Water Supplies Regulations (Northern Ireland) 2009
124.In regulation 4(b) of the Private Water Supplies Regulations (Northern...
SCHEDULE 35
Repeals and revocations
Explanatory Note
Yn ôl i’r brig