# The Medicines (Products for Animal Use—Fees) Regulations 1998, 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

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Source: https://www.legislation.gov.uk/uksi/1998/2428/schedule/1/part/IV/paragraph/2 (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-usefees-regulations-1998/schedule-1/part-IV/paragraph-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

