Paragraph 5 Marketing authorisations
Unless paragraphs 6 to 10 apply, the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation relating to a medicinal product of a kind described in column 1 of the following table is the applicable fee specified in the corresponding entry in column 2 of that table.
Periodic fees for holding a marketing authorisation
| Column 1Type of Medicinal Product | Column 2Fee payable | |||
|---|---|---|---|---|
| 1. New Active Substance | F1£11,627 | |||
| 2. Parallel Import | F2£368 | |||
| 3. Others | ||||
| (a) | Any product (not being a derivative of a new active substance) in respect of which a marketing authorisation has been granted in consequence of a complex application submitted on or after 1st April 1989 | F3£11,627 | ||
| (b) | Prescription Only Medicine | |||
| (i) | Standard Fee | F4£2,908 | ||
| (ii) | Reduced Rate Fee | F5£1,450 | ||
| (iii) | Lower Fee | F6£368 | ||
| (c) | Pharmacy | F7£368 | ||
| (d) | General Sale List | F8£368 | ||
| (e) | Herbal remedy | F9£92 | ||
| (f) | Traditional herbal registrations | £92 | ||
| (g) | National homoeopathic product | £92 | ||
| (h) | Homoeopathic or anthroposophic product which is the subject of a licence of right | £92 | ||
Annotations
Textual amendments
- F1
Sum in Sch. 4 para. 5 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), 29(2)(a)
- F2
Sum in Sch. 4 para. 5 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), 29(2)(b)
- F3
Sum in Sch. 4 para. 5 Table Entry 3(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(c)
- F4
Sum in Sch. 4 para. 5 Table Entry 3(b)(i) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(d)
- F5
Sum in Sch. 4 para. 5 Table Entry 3(b)(ii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(e)
- F6
Sum in Sch. 4 para. 5 Table Entry 3(b)(iii) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)
- F7
Sum in Sch. 4 para. 5 Table Entry 3(c) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)
- F8
Sum in Sch. 4 para. 5 Table Entry 3(d) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(f)
- F9
Sum in Sch. 4 para. 5 Table Entry 3(e)-(h) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(2)(g)