# The Medicines (Products for Human Use-Fees) Regulations 2008, Paragraph 30: Single set of changes


(1) Unless paragraph 31 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) £524, in respect of a product which is the subject of a United Kingdom marketing authorization other than a parallel import licence; and
(b) £332, in respect of a product which is the subject of a parallel import licence.
(2) But if the proposed changes in respect of a product to which the fee in sub-paragraph (a) applies are submitted in accordance with the BROMI labels and leaflets self – certification procedure the fee payable under regulation 22(1) is £188.
(3) For the purpose of this paragraph changes are submitted in accordance with the BROMI self -certification procedure if they are of a type described in the BROMI labels and leaflets self-certification guidance and comply with the conditions set out in relation to those changes in that guidance.

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Source: https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/30 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-30
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.