The Medicines (Products for Human Use) (Fees) Regulations 2013 No. 532

SCHEDULES

SCHEDULE 2 Capital fees for applications for, and variations to, marketing authorisations, licences, registrations and certificates

PART 4 Capital Fees for Applications for Variations of Authorisations, Licences and Registrations

Complex Variation Applications

51.—(1) Where more than one application of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorisation holder and all of the applications are for identical kinds of variations, the fee payable under regulation 18(1)—

(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of the Schedule; and

(b) in connection with each of the other applications in respect of which no further medical, scientific or pharmaceutical assessment is required, is the amount which would be payable if the application was a Type II Application.

(2) The type of application referred to in sub-paragraph (1) is a—

(a) Type II Complex Variation Application;

(b) Extended Type II Complex Variation Application;

(c) Major Variation (Type II) Complex Group Application; or

(d) Major Variation (Type II) Extended Complex Group Application.