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Paragraph 8 Decentralised procedure application

Original text. Later amendments are not shown.

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.