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Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT FOR PANDEMIC INFLUENZA VACCINE MARKETING AUTHORISATION APPLICATION
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
This guideline provides the basis for a fast track authorisation procedure for pandemic influenza vaccines within the EU. The procedure that is explained in detail below involves the submission and approval of a core pandemic dossier during the interpandemic period, which is based on a mock-up vaccine.
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