PART 4Capital Fees for Assistance in Obtaining Marketing Authorisations in Other EEA States
Meaning of “set of applications”
15. For the purposes of this Part, a “set of applications” means—
(a)a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorisation in other EEA States, but only if all the applications relate to applications for marketing authorisations in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive; or
(b)a number of applications to competent authorities of other EEA States for marketing authorisations relating to a single United Kingdom marketing authorisation, but only if all the applications have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive.
Fees for applications for regulatory assistance under the mutual recognition procedure
16. The fee payable by an applicant to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorisation in another EEA State or in other EEA States, is the fee prescribed in Part 3 of Schedule 2 in connection with the application or set of applications.
Time for payment of fees under regulation 16
17. Unless regulation 49 (applications made by small companies) applies, all sums payable by way of fees under regulation 16 must have been paid at the time when, in connection with the application or set of applications for regulatory assistance, a request is made under the second sub-paragraph of Article 28(1) of the 2001 Directive for an assessment report to be prepared or updated.