Paragraph 4 Insertion of regulation 27A (fee for renewals of a marketing authorisation)

After regulation 27, insert—

“Fee for renewals of a marketing authorisation

27A.

Where an application is made to the licensing authority for the renewal of a marketing authorisation and the application for renewal—

(a)

relates to a medicinal product which, at the time the marketing authorisation was granted, contained a new active ingredient; and

(b)

is the first renewal in relation to that product,

the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 2.”.