# The Medicines (Products for Human Use) (Fees) Regulations 2012, Paragraph 49: A set of changes


(1) Unless paragraph 50 applies, the fee payable under regulation 22(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is—
(a) £559, in respect of a product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence); and
(b) £354, 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 22(1) is £201.
(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) – 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/nisr/2012/134/schedule/2/paragraph/49 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-49
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.