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Paragraph 11 Mutual recognition procedure incoming application

Original text. Later amendments are not shown.

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

(a)

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

(b)

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