Paragraph 8 Pharmacologically equivalent products
(1)
The fee for an application for a marketing authorisation for a product that is pharmacologically equivalent to a product authorised in the United Kingdom is £4,995.
(2)
This is referred to in this Schedule as an “application for a pharmacologically equivalent product”.
(3)
The fee for such an application where the reference product is authorised within the European Union but not within the United Kingdom is £6,390 plus any translation costs.