Paragraph 35A Early Access to Medicines Scheme feesF1
The fee payable under regulation 12(1)(a) in connection with an application submitted under the Early Access to Medicines Scheme 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.
Fees for Early Access to Medicines Scheme applications
| Column 1 | Column 2 |
|---|---|
| Kind of Application | Fee payable |
| 1. Promising Innovative Medicine (PIM) designation | F2£4,852 |
| 2. EAMS scientific opinion for new medicinal products | F3£31,214 |
| 3. Renewal of an EAMS scientific opinion for new chemical or biological medicinal products | F4£15,607 |
| 4. EAMS scientific opinion for new indications | F5£10,115 |
| 5. Renewal of an EAMS scientific opinion for new indications | F6£5,057 |
Annotations
Textual amendments
- F1
Sch. 2 para. 35A inserted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(14)
- F2
Sum in Sch. 2 para. 35A Table Entry 1 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(a)
- F3
Sum in Sch. 2 para. 35A Table Entry 2 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(b)
- F4
Sum in Sch. 2 para. 35A Table Entry 3 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(c)
- F5
Sum in Sch. 2 para. 35A Table Entry 4 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(d)
- F6
Sum in Sch. 2 para. 35A Table Entry 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(13)(e)