Paragraph 15 Application for an extension to a marketing authorisationI1
United Kingdom
The fee for an application for an extension to a marketing authorisation is in accordance with the following table.
Extension to a marketing authorisation
| Extension | Fee if the marketing authorisation is UK only (£) | Fee for a decentralised application where the United Kingdom is a concerned member State or the mutual recognition of an extension authorised in another member State (£) |
|---|---|---|
| Change of strength or potency or the addition of a new strength or potency: | 6,400 | 3,180 |
| Change of pharmaceutical form or the addition of a new pharmaceutical form: | 8,080 | 3,690 |
| Change of route of administration, or the addition of a new one, of—
| 5,170 | 2,790 |
| 6,850 | 3,300 |
| Change or addition of target species: | 9,240 | 4,080 |
| Change of active substance: | 8,080 | 3,690 |
| Other: | 8,080 | 3,690 |
| Simultaneous application —fee for each additional product in the application: | 2,780 | 1,610 |
Annotations
Commencement
- I1
Sch. 7 para. 15 in force at 1.10.2006, see reg. 1