# The Medicines (Products for Animal Use — Fees) Regulations 1995, Paragraph 5: Marketing authorisations and product licences


(1) Subject to sub-paragraphs (2) and (3), where an application for a marketing authorisation or product licence consists of an application for more than one such authorisation or licence each relating to a product containing the same active ingredient or combination of ingredients, the fee shall be of an amount equal to the aggregate of the amounts payable under paragraph 1 in respect of separate applications for each such authorisation or licence.
(2) If the application is a major application, the fee shall be the amount payable in respect of a major application under paragraph 1 plus—
(a) in respect of each additional marketing authorisation or product licence applied for which relates to a product of a different dosage form, the amount payable in respect of a complex application under paragraph 1; and
(b) in respect of each additional marketing authorisation or product licence applied for which relates to a product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a standard application under paragraph 1.
(3) If the application is a complex application, the amount payable shall be the amount payable in respect of a complex application under paragraph 1 plus—
(a) in respect of each additional marketing authorisation or product licence applied for which relates to a product of a different dosage form, the amount payable in respect of a standard application under paragraph 1; and
(b) in respect of each additional marketing authorisation or product licence applied for which relates to a product of the same dosage form but of a different strength of active ingredient or different combination of active ingredients, the amount payable in respect of a simple application under paragraph 1.

---
Source: https://www.legislation.gov.uk/uksi/1995/2364/schedule/1/paragraph/5 (the official version)
Page: https://openlegislation.uk/medicines-products-for-animal-use-fees-regulations-1995/schedule-1/paragraph-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.