Paragraph 24 Marketing authorisations
Unless sub-paragraphs (2) or (4) or paragraphs 25, 26, 28 or 29 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorisation of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.
This paragraph applies—
to a complex application for a marketing authorisation of a kind described in item 2 in column 1 of the following table; and
where the application only concerns a new source or supply of a substance listed in Part 7 of this Schedule.
If sub-paragraph (2) applies the appropriate fee is the amount specified for an application of the same type under item 3 of the following table.
This paragraph applies—
to a complex application for a parallel import licence of a kind described in item 5(c) in column 1 of the following table; and
where the application only concerns a new source or supply of a relevant substance listed in Part 7 of this Schedule.
If sub-paragraph (4) applies the appropriate fee is the amount specified for item 5(b) in the following table.
F1Fees for marketing authorisation applications
Column 1 Kind of application | Column 2 Fee payable | |
|---|---|---|
| 1. Major Application | ||
| (a) | in respect of an application relating to an orphan medicinal product to which point 6 of Part II of Annex 1 to the 2001 Directive applies | F2£39,811 |
| (b) | which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | F3£83,580 |
| (c) | which is a European reference product application in the case of a product for sale or supply in Northern Ireland | £83,580 |
| (d) | which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for UKMA(GB) | £83,580 |
| (e) | in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 | F4£24,688 |
| F5. . . | . . . | . . . |
| F6. . . | . . . | . . . |
| (h) | in any other case | F7£124,194 |
| 2. Complex application | ||
| (a) | which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | F8£23,205 |
| (b) | which is a European reference product application in the case of a product for sale or supply in Northern Ireland | £23,205 |
| (c) | which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | £23,205 |
| (d) | in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 | F9£13,983 |
| F10. . . | . . . | . . . |
| F11. . . | . . . | . . . |
| (g) | in any other case | F12£34,335 |
| 3. Standard application | ||
| (a) | which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | F13£8,503 |
| (b) | which is a European reference product application in the case of a product for sale or supply in Northern Ireland | £8,503 |
| (c) | which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | £8,503 |
| (d) | in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 | F14£7,743 |
| F15. . . | . . . | . . . |
| F16. . . | . . . | . . . |
| (g) | in any other case | F17£12,589 |
| 4. Simple application | ||
| (a) | which is a mutual recognition procedure incoming application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | F18£3,433 |
| (b) | which is a decentralised procedure application in the case of a product for sale or supply in Northern Ireland, and the subsequent associated application under the unfettered access route for a UKMA(GB) | £3,433 |
| (c) | in respect of an application for a UKMA(GB) under the unfettered access route where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 | £3,433 |
| F19. . . | . . . | . . . |
| F20. . . | . . . | . . . |
| (f) | in any other case | F21£3,433 |
| 5. Parallel import licence applications | ||
| (a) | in respect of a simple parallel import licence | F22£2,400 |
| (b) | in respect of a standard parallel import licence | F23£10,617 |
| (c) | in respect of a complex parallel import licence | F24£24,343 |
| 6. Change of ownership application | F25£592 | |
Each reference in paragraphs 25, 27 and 28 to an amount payable under paragraph 24 in respect of an application refers to the amount payable under this paragraph in respect of an application of the kind in question.
Annotations
Textual amendments
- F1
Sch. 2 para. 24 Table substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 7(5) (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(g)(iv)); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Sum in Sch. 2 para. 24(5) Table Item 1(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(i)
- F3
Sum in Sch. 2 para. 24(5) Table Item 1(b)-(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(ii)
- F4
Sum in Sch. 2 para. 24(5) Table Item 1(e) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(iii)
- F5
Sch. 2 para. 24(5) Table Item 1(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(iv)
- F6
Sch. 2 para. 24(5) Table Item 1(g) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(v)
- F7
Sum in Sch. 2 para. 24(5) Table Item 1(h) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(a)(vi)
- F8
Sum in Sch. 2 para. 24(5) Table Item 2(a)-(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(i)
- F9
Sum in Sch. 2 para. 24(5) Table Item 2(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(ii)
- F10
Sch. 2 para. 24(5) Table Item 2(e) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(iii)
- F11
Sch. 2 para. 24(5) Table Item 2(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(iv)
- F12
Sum in Sch. 2 para. 24(5) Table Item 2(g) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(b)(v)
- F13
Sum in Sch. 2 para. 24(5) Table Item 3(a)-(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(i)
- F14
Sum in Sch. 2 para. 24(5) Table Item 3(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(ii)
- F15
Sch. 2 para. 24(5) Table Item 3(e) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(iii)
- F16
Sch. 2 para. 24(5) Table Item 3(f) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(iv)
- F17
Sum in Sch. 2 para. 24(5) Table Item 3(g) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(c)(v)
- F18
Sum in Sch. 2 para. 24(5) Table Item 4(a)-(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(i)
- F19
Sch. 2 para. 24(5) Table Item 4(d) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(ii)
- F20
Sch. 2 para. 24(5) Table Item 4(e) omitted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(iii)
- F21
Sum in Sch. 2 para. 24(5) Table Item 4(f) substituted (1.4.2025) by virtue of The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(d)(iv)
- F22
Sum in Sch. 2 para. 24(5) Table Item 5(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(e)(i)
- F23
Sum in Sch. 2 para. 24(5) Table Item 5(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(e)(ii)
- F24
Sum in Sch. 2 para. 24(5) Table Item 5(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(e)(iii)
- F25
Sum in Sch. 2 para. 24(5) Table Item 6 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(3)(f)