Regulation 27A Fee for renewals of a marketing authorisationF1

Where an application is made to the licensing authority for the renewal of a marketing authorisation in the case of a product for sale or supply in Great Britain 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.

Annotations

Textual amendments

F1: Reg. 27A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 4 (with Sch. 1 para. 11) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 188(e)); 2020 c. 1, Sch. 5 para. 1(1)