New phase dating dk

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If the application cannot be approved after the initial evaluation, the Danish Medicines Agency will give an intended refusal as well as forward a list of questions (Lo Q) to the applicant.The applicant for a new national application has up to six months to respond to the Lo Q.The Danish Medicines Agency receives, registers, examines and validates applications.The time is calculated from receipt of a complete and valid application until the procedure start date (day 0).

The procedure is described below (see 'Procedure phases') and apply to new marketing authorisation applications for medicinal products as well as variation applications submitted under the national procedure as referred to in , as amended.Please also see our separate guidelines on applications for national variations.In regard to applications for a parallel import authorisation or an IA variation, the case is closed after the assessment phase with a decision.Compared to the procedure introduced in 2002, the number of phases has been cut from four to three for national applications.This has been done, because the last phase (the closing phase) never had the intended effect, which was to reduce the volume of outstanding issues to a few and simple unresolved issues.

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