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The Medicines (Products for Human Use) (Fees) Regulations 2016
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Changes to Legislation
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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
Standard variation application for a homoeopathic medicinal productU.K.
This section has no associated Explanatory Memorandum
21. A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorisation for a national homoeopathic product which requires—
(a)the replacement of an excipient used in the manufacture of the product;
(b)the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;
(c)a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;
(d)a change to the method of manufacture of a homoeopathic stock included in the product;
(e)a change to the specification of any reagent or excipient used in the manufacture of the product;
(f)a change to the finished product specification of the product;
(g)a change to the test procedure for any raw material used in the manufacture of the product;
(h)a change to the test procedure for the product;
(i)a change to the test procedure for the container or other form of packaging immediately in contact with the product;
(j)a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;
(k)a change to the shape of the container in which the product may be placed on the market;
(l)an additional pack size in which the product may be placed on the market;
(m)a change to the approved storage conditions for the product;
(n)a change to the shelf life of an unopened container of the product after the container has been opened for the first time;
(o)a change to the dimensions of an approved dosage form of the product (for example, tablets); or
(p)a change following modification to the manufacturing authorisation referred to in Article 40 of the 2001 Directive.
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