8. A decentralised procedure application is a major application, a complex application, a standard application or a simple application for a marketing authorization for a medicinal product in respect of which at the time of the application—
(a)a marketing authorization has not been granted in any EEA State; and
(b)an application for a marketing authorization has been made in more than one EEA State pursuant to the procedure in Title III, Chapter 4 of the 2001 Directive.