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

Current effective version

Guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines - Revision 2

AdoptedLegal effective date: 28/01/2022Reference Number: EMA/CVMP/IWP/105506/2007 Rev. 2

Questions and Answers on data requirements for multi-strain dossiers for inactivated veterinary vaccines

Reference Number: EMA/CVMP/IWP/466888/2017-Rev.2

Document history - Revision 2

Guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines - Revision 2

AdoptedLegal effective date: 28/01/2022Reference Number: EMA/CVMP/IWP/105506/2007 Rev. 2

Questions and Answers on data requirements for multi-strain dossiers for inactivated veterinary vaccines

Reference Number: EMA/CVMP/IWP/466888/2017-Rev.2

Draft guideline on data requirements for multi-strain dossiers for inactivated veterinary vaccines

Consultation dates: 25/06/2021 to 30/09/2021Draft: consultation closedReference Number: EMA/CVMP/IWP/105506/2007 Rev. 2

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)

Reference Number: EMA/CVMP/IWP/532516/2021

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

Consultation dates: 29/01/2021 to 31/03/2021Draft: consultation closedReference Number: EMA/CVMP/IWP/600275/2020

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

AdoptedLegal effective date: 01/07/2019Reference Number: EMA/CVMP/IWP/105506/2007 Rev. 1Summary:

This guideline updates the ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD)’ (EMA/CVMP/IWP/105506/2007).

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

Reference Number: EMA/CVMP/IWP/235788/2018

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

Reference Number: EMA/CVMP/IWP/466888/2017 Rev. 1

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

Consultation dates: 18/09/2017 to 31/03/2018Draft: consultation closedReference Number: EMA/CVMP/IWP/105506/2007-Rev.1Summary:

This guideline was first published in 2010 based on general scientific and regulatory principles in advance of much practical experience from assessing applications through European authorisation procedures. This revision was prepared following a review by CVMP of issues raised by stakeholders based on their experience of operating the guideline. Only minor changes were considered necessary to the guideline itself and an accompanying ‘Question and Answer’ document was produced to address the topics raised by stakeholders that are not specifically addressed within the revised guideline.

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

Consultation dates: 28/09/2016 to 31/12/2016Draft: consultation closedReference Number: EMA/CVMP/IWP/867388/2015Summary:

The Immunologicals Working Party recommends to review, and possibly revise, the Committee for Medicinal Products for Veterinary Use ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, blue tongue and foot and mouth disease’, in order to take into account issues identified since the guideline came into effect and experience gained during assessment of recent applications for marketing authorisations. To ensure that all potential issues are covered, the IWP is relying on industry’s cooperation during the consultation period of this concept paper. It is important to identify any remaining issues not covered by the existing guideline or listed in this concept paper and the corresponding level of clarification needed.

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

Reference Number: EMA/CVMP/IWP/466888/2017

Guideline on data requirements for multistrain dossiers for inactivated vaccines against avian influenza, bluetongue and foot-and-mouth disease - First version

AdoptedLegal effective date: 01/07/2010Reference Number: EMA/CVMP/IWP/105506/2007

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

Reference Number: EMA/33491/2010Summary:

Overview of comments received on ‘Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), blue tongue (BT) and foot and mouth disease (FMD)’ (EMEA/CVMP/IWP/105506/2007) 

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

Draft: consultation closedReference Number: EMEA/CVMP/IWP/105506/2007

Concept paper on requirements for multi-strain dossiers - First version

Reference Number: EMEA/CVMP/IWP/90459/2007Summary:

Concept paper on requirements for multi-strain dossiers