Multidisciplinary: Vaccines

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This page lists the scientific guidance documents on vaccines.

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

Adopted guideline

Draft guideline

EMA/PRAC/222346/2014April 201415 April 2014 
Influenza vaccines – submission and procedural requirements

Adopted guideline

Overview of comments

Draft guideline

EMA/56793/2014July 2015July 2015 
Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure

Adopted guideline

Overview of comments

Draft guideline

EMA/CHMP/BWP/99698/2007 Rev. 2April 20131 May 2013 
Submission of marketing-authorisation applications for pandemic influenza vaccines through the centralised procedureAdopted guidelineEMEA/CPMP/4986/03April 2004April 2004 
Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure

Adopted guideline

Overview of comments

Draft guideline

EMA/CHMP/BWP/99698/2007 Rev. 1December 2010February 2011  
Influenza vaccines - Quality module

Overview of comments

Adopted guideline

Draft quality module

Concept paper

EMA/CHMP/BWP/310834/2012June 20141 November 2014 
Annex I variation application(s) content for live attenuated influenza vaccines

Adopted guideline

Overview of comments

Draft guideline

EMA/CHMP/BWP/577998/2010August 2011October 2011 
Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines

Adopted guideline

Draft guideline

Concept paper

EMA/CHMP/VWP/141697/2009August 2010January 2011 
Guidance for DNA vaccinesConcept paperEMEA/CHMP/308136/2007Released for consultation March 2011 Deadline for comments 30 June 2012
Guidance for DNA vaccinesConcept paperEMEA/CHMP/308136/2007Released for consultation July 2007 Deadline for comments 31 October 2007
Influenza vaccines - Non-clinical and clinical moduleDraft guidelineEMA/CHMP/VWP/457259/2014Released for consultation July 2014 Deadline for comments 31 January 2015
Dossier structure and content for pandemic-influenza marketing-authorisation application

Adopted guideline

Draft guideline

Concept paper

EMEA/CPMP/VEG/4717/2003February 2009January 2009 
Clinical evaluation of new vaccines

Adopted guideline

Draft guideline

EMEA/CHMP/VWP/164653/05October 2006February 2007 
Annex to guideline on clinical evaluation of new vaccines: summary of product characteristics requirementsAdopted guidelineEMEA/CHMP/VWP/382702/2006October 2006February 2007 
Influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context

Adopted guideline

Draft guideline

EMEA/CHMP/VWP/263499/2006July 2006February 2007 
Adjuvants in vaccines for human useAdopted guidelineEMEACHMP/VEG/134716/2004January 2005July 2005Also see explanatory note below
Explanatory note on immunomodulators for the guideline on adjuvants in vaccines for human useAdopted guidelineEMEA/CHMP/VWP/244894/2006July 2006July 2006Also see guideline above
Development of a Committee for Proprietary Medicinal Products note for guidance on the on requirements for the evaluation of new adjuvants in vaccinesConcept paperCPMP/BWP/6622/02April 2002  
Core summary of product characteristics for pandemic influenza vaccinesAdopted guidelineEMEA/CHMP/VEG/193031/2004August 2009August 2009 
Development of Vaccinia virus-based vaccines against smallpoxAdopted note for guidanceCPMP/1100/02June 2002July 2002 
Thiomersal-containing medicinal productsPublic statementEMEA/20962/99July 1999  
The reduction, elimination or substitution of thiomersal in vaccinesAdopted points to considerCPMP/BWP/2517/00April 2001May 2001 
Thiomersal in vaccines for human use - Recent evidence supports safety of thiomersal-containing vaccinesPublic statementEMEA/CPMP/VEG/1194/04March 2004  
Thiomersal: Implementation of the warning statement relating to sensitisationPosition paperEMEA/CHMP/VWP/19541/2007January 2007  
Development of a Committee for Proprietary Medicinal Products points to consider on stability and traceability requirements for vaccine intermediatesConcept paperCPMP/BWP/4310/00January 2001  
Live attenuated influenza vaccines

Adopted points to consider

Concept paper

EMEA/CPMP/BWP/1765/99July 1999  
Cell-culture-inactivated influenza vaccinesAdopted guidelineCPMP/BWP/2490/00January 2002August 2002 
Development of a Committee for Proprietary Medicinal Products note for guidance on cell-derived influenza vaccinesConcept paperCPMP/BWP/1764/99July 1999  
Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines

Adopted explanatory note

Draft explanatory note

EMA/CHMP/VWP/40560/2014February 2014 Also see guidance below
Harmonisation of requirements for influenza vaccinesNote for guidanceCPMP/BWP/214/96March 1997April 1997Also see explanatory note above

 

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