# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 54: A set of changes


(1) Unless paragraph 55 applies, the fee payable under regulation 25(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—
(a) £992, in respect of a product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence); and
(b) £440, in respect of a product which is the subject of a parallel import licence.
(2) If the proposed changes in respect of a product to which the fee in sub-paragraph (1)(a) applies are submitted in accordance with the National Guidance on labels and leaflets self-certification, the fee payable under regulation 25(1) is £224.
(3) For the purpose of this paragraph—
(a) changes are submitted in accordance with the National Guidance on labels and leaflets self-certification if they are of a type described in the National Guidance on labelling and patient information leaflets for self-certification and comply with the conditions set out in relation to those changes in that Guidance; and
(b) the “National Guidance on labelling and patient information leaflets for self-certification” means the documents entitled “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with Article 56(a) of the 2001 Directive – inclusion of Braille on the labelling” published by the licensing authority and available on its website .

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/54 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-54
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.