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