# The Medicines (Products for Human Use) (Fees) Regulations 2016, Paragraph 40: Reclassification of marketing authorisations


(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 19(1) in connection with the application for variation of a marketing authorisation is £1,593.
(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorisation relates—
(a) is to be available only from a pharmacy (where previously it was available only on prescription), if an analogous medicinal product is available only from a pharmacy or on general sale; or
(b) is to be available on general sale (where previously it was available only on prescription or only from a pharmacy), if an analogous medicinal product is available on general sale.
(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorisation or a European Union marketing authorisation and which—
(a) has the same active ingredient, route of administration and use;
(b) has the same strength or a higher strength;
(c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and
(d) is for sale or supply at the same quantity or a greater quantity,
as the medicinal product in relation to which the variation application is made.

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Source: https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/40 (the official version)
Page: https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-40
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.