Requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue

VeterinaryRegulatory and procedural guidanceScientific guidelines

This document provides guidance on the minimum data requirements for authorisation of bluetongue vaccines for emergency use under Article 26 of Directive 2001/82/EC, as amended, and Article 39(7) of Regulation 726/2004.

Keywords: Authorisation under exceptional circumstances, vaccines for emergency, bluetongue

Current effective version

Guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue

Adopted Reference Number: EMEA/CVMP/IWP/220193/2008 Legal effective date:

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Document history

Overview of comments received on draft guideline on guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue

Reference Number: EMEA/CVMP/IWP/521211/2008

English (EN) (46.5 KB - PDF)

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Draft guideline on requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue

Draft: consultation closed Reference Number: EMEA/CVMP/IWP/220193/2008-CON.

English (EN) (65.46 KB - PDF)

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Concept paper on minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue

Reference Number: EMEA/CVMP/IWP/37267/2008

English (EN) (45.8 KB - PDF)

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Reflection paper: Minimum data requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue

Adopted Reference Number: EMEA/CVMP/IWP/105008/2007 Legal effective date:

English (EN) (40.62 KB - PDF)

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