Paragraph 11 Mutual recognition procedure incoming application
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.