Paragraph 53 Multiple reclassification variation applications

Where more than one reclassification variation application is made at the same time by the same applicant, each relating to medicinal products which have the same active ingredient or combination of ingredients, the fee payable under regulation 19(1)—

(a)

if one or more of the applications is an application to which paragraph 40 does not apply—

(i)

in connection with the first application to which paragraph 40 does not apply, is the appropriate amount specified in this Part of the Schedule;

(ii)

in connection with each other application to which paragraph 40 does not apply, the fee payable is F1£1,308; and

(iii)

in connection with each other application to which paragraph 40 does apply, the fee payable is £367; and

(b)

in any other case—

(i)

in connection with the first application, is the appropriate amount specified in this Part of the Schedule; and

(ii)

in connection with each other application, the fee payable is £367.

Annotations

Textual amendments

F1: Sum in Sch. 2 para. 53(a)(ii) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 24(25)