Paragraph 5 Marketing authorizations
Unless paragraphs 6 to 10 apply, the fee payable under regulation 31(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.
Table 1
Column 1 Kind of product | Column 2 Fee payable | |||
|---|---|---|---|---|
| 1. New Active Substance | £21,108 | |||
| 2. Other kinds of Medicinal Product— | ||||
| (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 | £8,692 | ||
| (b) | Prescription Only Medicine | |||
| (i) | Standard Fee | £2,174 | ||
| (ii) | Reduced Rate Fee | £1,085 | ||
| (iii) | Maintenance Fee | £352 | ||
| (c) | Pharmacy Medicine | |||
| (i) | Standard Fee | £951 | ||
| (ii) | Reduced Rate Fee | £476 | ||
| (iii) | Maintenance Fee | £176 | ||
| (d) | General Sale List Medicine | |||
| (i) | Standard Fee | £393 | ||
| (ii) | Reduced Rate Fee | £195 | ||
| (iii) | Maintenance Fee | £85 | ||
| (e) | Herbal Remedy | £108 | ||
| (f) | National homoeopathic product | £77 | ||
| (g) | Homoeopathic or anthroposophic product which is the subject of a licence of right | £70 | ||