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Paragraph 2 Marketing authorisations (other than mutually recognised marketing authorisations) and product licences

Original text. Later amendments are not shown.

The fee for an application of the kind described 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 shall be that specified in the corresponding entry in column (2) of that Table.

Table E

Column (1)Column (2)
Kind of applicationFee
Variation requiring veterinary, scientific or pharmaceutical assessment£375 for the first variation plus £155 for each additional consequential variation to other authorisations or licences in identical terms
Variation not requiring veterinary, scientific or pharmaceutical assessment£155
Variation involving the re-issue of the licence in the new name of the company£155
Variation where the product licence relates solely to an emergency vaccine£40