Marketing authorizations
This section has no associated Explanatory Memorandum
5. Unless paragraphs 6 to 10 apply, the fee payable under regulation 33(3) in connection with the holding of a marketing authorization 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 marketing authorization
Column 1 Type of Medicinal Product | Column 2 Fee payable | |||
|---|---|---|---|---|
| 1. New Active Substance | £23,025 | |||
| 2. Parallel Import | £300 | |||
| 3. Others | ||||
| (a) | Any product (not being a derivative of a new active substance) in respect of which a marketing authorization has been granted in consequence of a complex application submitted on or after 1st April 1989 | £9,481 | ||
| (b) | Prescription Only Medicine | |||
| (i) | Standard Fee | £2,371 | ||
| (ii) | Reduced Rate Fee | £1,183 | ||
| (iii) | Lower Fee | £300 | ||
| (c) | Pharmacy | £300 | ||
| (d) | General Sale List | £300 | ||
| (e) | Herbal remedy | £75 | ||
| (f) | Traditional herbal registrations | £75 | ||
| (g) | National homoeopathic product | £75 | ||
| (h) | Homoeopathic or anthroposophic product which is the subject of a licence of right | £75 | ||