Data requirements for multi-strain dossiers for inactivated veterinary vaccines - Scientific guideline

The main aim of the guideline is to address the use of a multi-strain dossier for inactivated vaccines against antigenically variable viruses or bacteria and to provide information on criteria for eligibility to use the multi-strain approach and on data to be included in a multi-strain dossier.

Keywords: Multi-strain dossier, inactivated veterinary vaccines

Data requirements for multi-strain dossiers for inactivated veterinary vaccines - Scientific guideline

Table of contents

Current effective version

Guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines - Revision 2 (PDF/253.6 KB)

Questions and Answers on data requirements for multi-strain dossiers for inactivated veterinary vaccines (PDF/164.61 KB)

Document history - Revision 2

Guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines - Revision 2 (PDF/253.6 KB)

Questions and Answers on data requirements for multi-strain dossiers for inactivated veterinary vaccines (PDF/164.61 KB)

Draft guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines (PDF/241.59 KB)

Overview of comments received on 'Draft revised guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines’ (EMA/CVMP/IWP/105506/2007 Rev. 2) (PDF/342.62 KB)

Draft concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD) - Revision 2 (PDF/197.18 KB)

Document history - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1 (PDF/141.8 KB)

Overview of comments received on 'Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD)' - Revision 1 (PDF/119.92 KB)

Questions and answers on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1 (PDF/104.5 KB)

Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - Revision 1 (PDF/154.79 KB)

Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease - Revision 1 (PDF/85.21 KB)

Document history - First version

Questions and answers on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) - First version (PDF/87.54 KB)

Guideline on data requirements for multistrain dossiers for inactivated vaccines against avian influenza, bluetongue and foot-and-mouth disease - First version (PDF/103.38 KB)

Overview of comments received on ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot and mouth disease (FMD)’ - First version (PDF/169.71 KB)

Draft guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot and mouth disease (FMD) - First version (PDF/100.54 KB)

Concept paper on requirements for multi-strain dossiers - First version (PDF/30.34 KB)

Related content

Recommendation on the submission of multistrain-dossier applications for vaccines against avian influenza, bluetongue and foot-and-mouth disease (PDF/130.63 KB)

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