Paragraph 15 Additional amount for manufacturer's licences and wholesale dealer's licences which relate to special medicinal products
The additional amount referred to in paragraphs 11(3) and 14 in relation to any fee period is—
the fee specified in the entry in column 2 of Table 1 (additional periodic fee in connection with notices for imported special medicinal products) corresponding to the estimated number of special import notices for that fee period specified in column 1, and
the fee specified in the entry in column 2 of Table 2 (additional periodic fee in connection with the number of different special medicinal products imported) corresponding to the estimated number of different special medicinal products imported for that fee period specified in column 1.
F2Table 1
Additional periodic fee in connection with notices for imported special medicinal products
| Column 1 | Column 2 |
|---|---|
| Number of special import notices | Additional amount |
| 1 to 20 | £86 |
| 21 to 100 | £427 |
| 101 to 500 | £2,131 |
| 501 to 1,000 | £4,261 |
| 1,001 to 2,000 | £8,521 |
| 2,001 to 5,000 | £17,042 |
| 5,001 to 10,000 | £34,083 |
| 10,001 to 15,000 | £51,125 |
| 15,001 to 20,000 | £68,166 |
| 20,001 to 25,000 | £85,208 |
| 25,001 to 30,000 | £102,249 |
| 30,001 to 35,000 | £119,291 |
| 35,001 to 40,000 | £136,333 |
| 40,001 to 45,000 | £153,375 |
| 45,001 to 50,000 | £170,417 |
| Each additional 5,000 above 50,000 | £170,417 plus £17,042 for each additional 5,000 special import notices |
Table 2
Additional periodic fee in connection with the number of different special medicinal products notified for import
| Column 1 | Column 2 |
|---|---|
| Number of different special medicinal products notified for import | Additional amount |
| 1 to 5 | F3£122 |
| 6 to 10 | F4£244 |
| 11 to 20 | F5£487 |
| 21 to 50 | F6£1,218 |
| 51 to 100 | F7£2,435 |
| 101 to 200 | F8£,4,869 |
| For each additional 100 special medicinal products notified for import above 200 | F9£4,869 plus £2,435 for each additional 100 special medicinal products notified for import |
For the purposes of this paragraph, the estimated number of special import notices for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.
For the purposes of this paragraph, the estimated number of different special medicinal products notified for import for any fee period shall be the number notified in writing to the licence holder by the licensing authority before the start of that fee period as the number of such notices which the authority estimate will be given by the holder during the fee period.
Annotations
Textual amendments
- F1
Sch. 4 para. 15(1) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 26(7)
- F2
Sch. 4 para. 15(1)(b) Table 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(a)
- F3
Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(i)
- F4
Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(ii)
- F5
Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(iii)
- F6
Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(iv)
- F7
Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(v)
- F8
Sum in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(vi)
- F9
Words in Sch. 4 para. 15(1)(b) Table 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(7)(b)(vii)
- F10
Sch. 4 para. 15(3) inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 26(8)