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The Medicines (Products for Human Use) (Fees) Regulations 2016
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Marketing authorisations
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5. 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 1 Type of Medicinal Product | Column 2 Fee payable | |||
|---|---|---|---|---|
| 1. New Active Substance | £9,710 | |||
| 2. Parallel Import | £307 | |||
| 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 | £9,710 | ||
| (b) | Prescription Only Medicine | |||
| (i) | Standard Fee | £2,428 | ||
| (ii) | Reduced Rate Fee | £1,211 | ||
| (iii) | Lower Fee | £307 | ||
| (c) | Pharmacy | £307 | ||
| (d) | General Sale List | £307 | ||
| (e) | Herbal remedy | £76 | ||
| (f) | Traditional herbal registrations | £76 | ||
| (g) | National homoeopathic product | £76 | ||
| (h) | Homoeopathic or anthroposophic product which is the subject of a licence of right | £76 | ||
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