Paragraph 18 Application for an extension to a marketing authorisation
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 | 6,570 | 3,250 |
| Change of pharmaceutical form or the addition of a new pharmaceutical form | 8,290 | 3,780 |
| Change of route of administration, or the addition of a new one, of
| 5,310 | 7,030 |
| – a pharmaceutical product for a food-producing animal: | 2,850 | 3,380 |
| Change or addition of target species | 9,480 | 4,180 |
| Change of active substance | 8,290 | 3,780 |
| Other | 8,290 | 3,780 |
| Simultaneous application: fee for each additional product in the application | 2,850 | 1,660 |