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The Medicines (Products for Human Use) (Fees) Regulations 2016
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- UK Statutory Instruments
- 2016 No. 190
- PART 5
- Regulation 19E
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Changes to legislation:
There are outstanding changes not yet made by the legislation.gov.uk editorial team to The Medicines (Products for Human Use) (Fees) Regulations 2016. Any changes that have already been made by the team appear in the content and are referenced with annotations.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to Regulation 19E:
- Sch. 2 para. 35A inserted by S.I. 2023/314 reg. 24(14)
- Sch. 2 para. 27(2)(a)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(i)
- Sch. 2 para. 27(2)(b)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(ii)
- Sch. 2 para. 27(2)(c)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(iii)
- Sch. 2 para. 27(2)(d)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(iv)
- Sch. 2 para. 27(3)(a)(i) sum substituted by S.I. 2023/314 reg. 24(5)(b)
- Sch. 2 para. 28(2)(a)(i) sum substituted by S.I. 2023/314 reg. 24(6)(a)(i)
- Sch. 2 para. 28(2)(b)(i) sum substituted by S.I. 2023/314 reg. 24(6)(a)(ii)
- Sch. 2 para. 28(2)(c)(i) sum substituted by S.I. 2023/314 reg. 24(6)(a)(ii)
- Sch. 2 para. 28(3)(b)(i) sum substituted by S.I. 2023/314 reg. 24(6)(b)
- Sch. 2 para. 28(3)(c)(i) sum substituted by S.I. 2023/314 reg. 24(6)(b)
- Sch. 2 para. 28A(1)(a)-(c) sum substituted by S.I. 2023/314 reg. 24(7)(a)
- Sch. 2 para. 28A(2)(a)-(c) sum substituted by S.I. 2023/314 reg. 24(7)(b)
- Sch. 2 para. 56(c) sum substituted by S.I. 2023/314 reg. 24(27)(b)
- Sch. 2 para. 57A(a) sum substituted by S.I. 2023/314 reg. 24(29)(a)
- Sch. 2 para. 57A(b) sum substituted by S.I. 2023/314 reg. 24(29)(b)
- Sch. 2 para. 57A(c) sum substituted by S.I. 2023/314 reg. 24(29)(c)
- Sch. 2 para. 57A(d) sum substituted by S.I. 2023/314 reg. 24(29)(d)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(i)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(ii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(iii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(iv)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(v)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(vii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(viii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(ix)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(i)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(ii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(iii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(iv)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(v)
- Sch. 4 para. 15(3) inserted by S.I. 2023/314 reg. 26(8)
- reg. 19A(1) sum substituted by S.I. 2023/314 reg. 13(a)
- reg. 19A(2)(a) sum substituted by S.I. 2023/314 reg. 13(b)
- reg. 19A(2)(b) sum substituted by S.I. 2023/314 reg. 13(c)
- reg. 19B sum substituted by S.I. 2023/314 reg. 14
- reg. 19C(2)(a) sum substituted by S.I. 2023/314 reg. 15(a)(i)
- reg. 19C(2)(b) sum substituted by S.I. 2023/314 reg. 15(a)(ii)
- reg. 19C(2)(c) sum substituted by S.I. 2023/314 reg. 15(a)(iii)
- reg. 19C(3)(a) sum substituted by S.I. 2023/314 reg. 15(b)(i)
- reg. 19C(3)(b) sum substituted by S.I. 2023/314 reg. 15(b)(ii)
- reg. 19C(3)(c) sum substituted by S.I. 2023/314 reg. 15(b)(iii)
- reg. 19E(2)(a) sum substituted by S.I. 2023/314 reg. 16(a)
- reg. 19E(2)(b) sum substituted by S.I. 2023/314 reg. 16(b)
- reg. 19EA inserted by S.I. 2023/314 reg. 17
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. 2 para. 35A inserted by S.I. 2023/314 reg. 24(14)
- Sch. 2 para. 27(2)(a)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(i)
- Sch. 2 para. 27(2)(b)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(ii)
- Sch. 2 para. 27(2)(c)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(iii)
- Sch. 2 para. 27(2)(d)(i) sum substituted by S.I. 2023/314 reg. 24(5)(a)(iv)
- Sch. 2 para. 27(3)(a)(i) sum substituted by S.I. 2023/314 reg. 24(5)(b)
- Sch. 2 para. 28(2)(a)(i) sum substituted by S.I. 2023/314 reg. 24(6)(a)(i)
- Sch. 2 para. 28(2)(b)(i) sum substituted by S.I. 2023/314 reg. 24(6)(a)(ii)
- Sch. 2 para. 28(2)(c)(i) sum substituted by S.I. 2023/314 reg. 24(6)(a)(ii)
- Sch. 2 para. 28(3)(b)(i) sum substituted by S.I. 2023/314 reg. 24(6)(b)
- Sch. 2 para. 28(3)(c)(i) sum substituted by S.I. 2023/314 reg. 24(6)(b)
- Sch. 2 para. 28A(1)(a)-(c) sum substituted by S.I. 2023/314 reg. 24(7)(a)
- Sch. 2 para. 28A(2)(a)-(c) sum substituted by S.I. 2023/314 reg. 24(7)(b)
- Sch. 2 para. 56(c) sum substituted by S.I. 2023/314 reg. 24(27)(b)
- Sch. 2 para. 57A(a) sum substituted by S.I. 2023/314 reg. 24(29)(a)
- Sch. 2 para. 57A(b) sum substituted by S.I. 2023/314 reg. 24(29)(b)
- Sch. 2 para. 57A(c) sum substituted by S.I. 2023/314 reg. 24(29)(c)
- Sch. 2 para. 57A(d) sum substituted by S.I. 2023/314 reg. 24(29)(d)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(i)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(ii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(iii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(iv)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(v)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(vii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(viii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(a)(ix)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(i)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(ii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(iii)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(iv)
- Sch. 2 para. 57B(4) sum substituted by S.I. 2023/314 reg. 24(30)(b)(v)
- Sch. 4 para. 15(3) inserted by S.I. 2023/314 reg. 26(8)
- reg. 19A(1) sum substituted by S.I. 2023/314 reg. 13(a)
- reg. 19A(2)(a) sum substituted by S.I. 2023/314 reg. 13(b)
- reg. 19A(2)(b) sum substituted by S.I. 2023/314 reg. 13(c)
- reg. 19B sum substituted by S.I. 2023/314 reg. 14
- reg. 19C(2)(a) sum substituted by S.I. 2023/314 reg. 15(a)(i)
- reg. 19C(2)(b) sum substituted by S.I. 2023/314 reg. 15(a)(ii)
- reg. 19C(2)(c) sum substituted by S.I. 2023/314 reg. 15(a)(iii)
- reg. 19C(3)(a) sum substituted by S.I. 2023/314 reg. 15(b)(i)
- reg. 19C(3)(b) sum substituted by S.I. 2023/314 reg. 15(b)(ii)
- reg. 19C(3)(c) sum substituted by S.I. 2023/314 reg. 15(b)(iii)
- reg. 19E(2)(a) sum substituted by S.I. 2023/314 reg. 16(a)
- reg. 19E(2)(b) sum substituted by S.I. 2023/314 reg. 16(b)
- reg. 19EA inserted by S.I. 2023/314 reg. 17
[F1Fee for assessment of periodic safety update reportsU.K.
This section has no associated Explanatory Memorandum
19E.—(1) This regulation applies where—
(a)a periodic safety update report has been submitted to the licensing authority under regulation 191 or 192 of the Human Medicines Regulations; and
(b)that periodic safety update report relates to a medicinal product which has a UK reference date within the meaning of regulation 193 of the Human Medicines Regulations.
(2) Where this regulation applies, the fee payable by the holder of a marketing authorisation or traditional herbal registration to which the periodic safety update report relates is—
(a)£890, in the case where no other periodic safety update reports relating to medicinal products with the same UK reference date are submitted; and
(b)£445, in any other case.]
Textual Amendments
F1Regs. 19A-19G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 2 (with Sch. 1 para. 11) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 188(c)(i)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)
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