Eudralex Volume 3 GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE
Title:
Eudralex Volume 3 GUIDELINE ON SUBMISSION OF MARKETING AUTHORISATION APPLICATIONS FOR PANDEMIC INFLUENZA VACCINES THROUGH THE CENTRALISED PROCEDURE
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 lays down the procedure to manufacturers/marketing authorisation applicants and Marketing authorisation holders on issues associated with the submission, and approval of a core pandemic dossier during the inter-pandemic period followed by a fast track approval of the pandemic vaccine, based on the submission of pandemic variation via the centralised procedure.