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Eudralex Volume 3 GUIDELINE ON DOSSIER STRUCTURE AND CONTENT OF MARKETING AUTHORISATION APPLICATIONS FOR INFLUENZA VACCINES DERIVED FROM STRAINS WITH A PANDEMIC POTENTIAL FOR USE OUTSIDE OF THE CORE DOSSIER CONTEXT

Origin/Publisher:

European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/

Document Type:
Guideline Draft
Content:
This guideline addresses the quality, non-clinical and clinical dossier requirements for influenza vaccines containing or derived from avian strains with a pandemic potential that are intended for use in humans outside of the context of a core dossier. It also gives guidance on post approval commitments, risk management plans and other post-authorisation activities related to these vaccines.

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