SCHEDULES

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

PART 1General: interpretation and categories of applications and variations

Mutual recognition procedure incoming application

11.

A mutual recognition procedure incoming application is a major application, a complex application or a standard application for a marketing authorisation for a medicinal product in respect of which—

(a)

a marketing authorisation has already been granted in another EEA State; and

(b)

recognition of that marketing authorisation is sought from the licensing authority by way of the grant of a marketing authorisation in the United Kingdom, under the procedure in Title III, Chapter 4 of the 2001 Directive.