Reclassification of marketing authorizations
37.—(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 18(1) in connection with the application for variation of a marketing authorization is £794.
(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorization 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 authorization or a European Union marketing authorization 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.