Paragraph 2 Marketing authorisations (other than mutually recognised marketing authorisations) and product licences
The fee for an application of a kind described in an entry in column (1) of Table E for the variation of–
(a)
a marketing authorisation, other than a mutually recognised marketing authorisation; or
(b)
a product licence,
other than a complex application, is that specified in the corresponding entry in column (2) of that Table.
Table E
| Column (1) | Column (2) |
|---|---|
| Kind of application | Fee |
| Variation requiring veterinary, scientific or pharmaceutical assessment (where the authorisation or licence is not related solely to an emergency vaccine) | £500 for each individual variation in that application plus £200 for each additional consequential individual variation to other authorisations or licences in identical terms |
| Variation not requiring veterinary, scientific or pharmaceutical assessment (where the authorisation or licence is not related solely to an emergency vaccine) | £200 in respect of each individual variation |
| Variation where the authorisation or licence relates solely to an emergency vaccine | £40 in respect of each individual variation |