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 F1£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.

Annotations

Textual amendments

F1: Sum in Sch. 2 para. 40(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(15)