PART 5Capital Fees for Applications for Variations of Authorisations, Registrations and Licences and for Associated Compliance Activities

Fees for variations of authorisations, registrations and licences19

1

Unless Part 16 of these Regulations (revocations and savings) applies, the fee mentioned in paragraph (2) applies for an application—

a

under the Human Medicines Regulations, under regulation—

i

29 (variation of licence on application of holder);

F3ii

65C (variation of a UK marketing authorisation)

iii

135 (revocation, variation and suspension of a traditional herbal registration) but only in relation to a variation of such a registration;

b

to vary a parallel import licence;

c

to vary a broker's registration or an active substance registration;

d

under regulation 44 (variation of manufacturing authorisation) of the Clinical Trials Regulations F1 for the variation of a manufacturing authorisation.

F4e

under Commission Regulation (EC) No 1234/2008 for the variation of a UKMA(UK) or UKMA(NI).

2

The fee referred to in paragraph (1) is—

a

the fee prescribed in Part 4 of Schedule 2 in connection with the application; and

b

in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 30, 32, 33, 35 and 37.

3

Unless regulation 32 applies, the fee referred to in paragraph (1) is payable by the applicant.

F24

The reference in paragraph (1)(a)(ii) to an application under regulation 65C of the Human Medicines Regulations includes a reference to an application or notification submitted under paragraph 11(7) or 12(3) of Schedule 33A to the Human Medicines Regulations, or an application or notification which would have been submitted under those paragraphs but for its earlier submission in accordance with paragraph 13(1)(a) of that Schedule.