# The Medicines (Products for Human Use) (Fees) Regulations 2016, Regulation 25: Fees for assessment of a set of proposed changes to labels and leaflets


(1) Unless paragraph (2) applies, where—
(a) a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or
(b) a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,
the fee payable by the holder of that authorisation or licence is the fee prescribed in Part 5 of Schedule 2 in connection with that change.
(2) Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorisation for that product.

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Source: https://www.legislation.gov.uk/uksi/2016/190/regulation/25 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-25
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.