London, 24 September 2009

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چکیده

As part of pandemic preparedness planning, the European Commission (EC) and the European Medicines Agency (EMEA) introduced a procedure to allow the submission and evaluation of core pandemic dossiers (for ‘mock-up’ vaccines) during the inter-pandemic period leading to marketing authorisations which could only be used during an officially declared pandemic (World Health Organization [WHO] Phase 6). The procedure foresees the fast track assessment of the data for replacing the strain in the mock-up vaccine with the recommended pandemic strain as a variation to the MA (Marketing Authorisation).

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تاریخ انتشار 2009