Biologics Working Party documents

Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2026/2027

Reference Number: EMA/CHMP/BWP/62405/2026

English (EN) (229.33 KB - PDF)

Prva objava: 30/03/2026 Zadnja posodobitev: 26/05/2026

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Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026

Reference Number: EMADOC-628903358-119194 Corr.1

English (EN) (144.19 KB - PDF)

Prva objava: 01/04/2025 Zadnja posodobitev: 13/05/2025

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Amended Biologics Working Party (BWP) Ad hoc Influenza Working Group - EU recommendations for the seasonal influenza vaccine composition for the season 2023/2024

Adopted Reference Number: EMA/CHMP/BWP/126676/2023

English (EN) (192.21 KB - PDF)

Prva objava: 03/04/2023 Zadnja posodobitev: 20/04/2023

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Amended Biologics Working Party (BWP) Ad hoc Influenza Working Group - EU recommendations for the seasonal influenza vaccine composition for the season 2022/2023

Reference Number: EMA/CHMP/BWP/116744/2022

English (EN) (175.47 KB - PDF)

Prva objava: 29/03/2022 Zadnja posodobitev: 30/03/2022

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Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2021/2022

Adopted Reference Number: EMA/CHMP/BWP/80561/2021

English (EN) (176.61 KB - PDF)

Prva objava: 30/03/2021 Zadnja posodobitev: 28/06/2021

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Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2020/2021

Adopted Reference Number: EMA/CHMP/BWP/134670/2020 Summary:

EU recommendations for the seasonal influenza vaccine composition for the season 2020/2021

English (EN) (205.91 KB - PDF)

Prva objava: 01/04/2020 Zadnja posodobitev: 15/05/2020

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Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2019/2020

Adopted Reference Number: EMA/CHMP/BWP/266098/2019

English (EN) (199.83 KB - PDF)

Prva objava: 01/04/2019 Zadnja posodobitev: 20/05/2019

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Biologics Working Party (BWP) ad-hoc influenza working group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2018/2019

Reference Number: EMA/CHMP/BWP/209019/2018

English (EN) (93.84 KB - PDF)

Prva objava: 26/03/2018 Zadnja posodobitev: 30/04/2018

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Biologics Working Party report on viral safety of plasma-derived and urine-derived medicinal products with respect to Zika virus

Reference Number: EMA/CHMP/BWP/596747/2016

English (EN) (115.31 KB - PDF)

Prva objava: 21/09/2016 Zadnja posodobitev: 21/09/2016

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Biologics Working Party (BWP) Ad-hoc Influenza Working Group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2017/2018

Reference Number: EMA/CHMP/BWP/216216/2017

English (EN) (83.23 KB - PDF)

Prva objava: 24/03/2017 Zadnja posodobitev: 12/04/2017

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Biologics Working Party Ad-hoc Influenza Working Group: European Union recommendations for the seasonal influenza vaccine composition for the season 2016/2017

Reference Number: EMA/CHMP/BWP/165983/2016 Summary:

Biologics Working Party Ad-hoc Influenza Working Group: European Union recommendations for the seasonal influenza vaccine composition for the season 2016/2017

English (EN) (106.94 KB - PDF)

Prva objava: 04/04/2016 Zadnja posodobitev: 04/04/2016

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Biologics Working Party Ad-hoc Influenza Working Group: Amended European Union recommendations for the seasonal-influenza-vaccine composition for the season 2015 / 2016

Reference Number: EMA/CHMP/BWP/169555/2015

English (EN) (153.35 KB - PDF)

Prva objava: 27/03/2015 Zadnja posodobitev: 27/05/2015

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Biologics Working Party Ad-hoc Influenza Working Group: European Union recommendations for the seasonal-influenza-vaccine composition for the season 2014 / 2015

Reference Number: EMA/CHMP/BWP/109993/2014

English (EN) (84.32 KB - PDF)

Prva objava: 21/03/2014 Zadnja posodobitev: 21/03/2014

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CHMP/Biologics Working Party report to the CMDh on pancreatin-containing products

Reference Number: EMEA/CHMP/BWP/373049/2013 Summary:

At the request of the CMDh, the Biologics Working Party (BWP) and the Committee for Medicinal Products for Human Use (CHMP) assessed the viral risk of pancreatin products and expressed their view on whether the SmPCs of these products should include a harmonised warning about their viral safety.

English (EN) (94.12 KB - PDF)

Prva objava: 04/10/2013 Zadnja posodobitev: 04/10/2013

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Biologics Working Party Ad-hoc Influenza Working Group: Amended European Union recommendations for the seasonal-influenza-vaccine composition for the season 2013 / 2014

Adopted Reference Number: EMA/CHMP/BWP/116620/2013

English (EN) (92.22 KB - PDF)

Prva objava: 16/03/2012 Zadnja posodobitev: 02/04/2013

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Biologics Working Party Ad-hoc Influenza Working Group: European Union recommendations for the seasonal-influenza-vaccine composition for the season 2011 / 2012

Adopted Reference Number: EMA/CHMP/BWP/156215/2011

English (EN) (65.24 KB - PDF)

Prva objava: 17/03/2011 Zadnja posodobitev: 17/03/2011

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European Union recommendations for the seasonal-influenza-vaccine composition for the season 2010 / 2011

Adopted Reference Number: EMA/CHMP/BWP/107653/2010

English (EN) (65.29 KB - PDF)

Prva objava: 18/03/2010 Zadnja posodobitev: 18/03/2010

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Report of plasma master file epidemiology workshop with industry

Reference Number: EMEA/CHMP/BWP/233408/2009

English (EN) (87.41 KB - PDF)

Prva objava: 19/11/2009 Zadnja posodobitev: 19/11/2009

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Report: Expert workshop on Creutzfeldt-Jakob-disease risk and urine-derived medicinal products

Reference Number: EMEA/CHMP/BWP/472717/2009

English (EN) (135.72 KB - PDF)

Prva objava: 23/07/2009 Zadnja posodobitev: 23/07/2009

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European Union recommendation for the emergent-novel-H1N1-influenza-vaccine composition - Revised to include strain IVR-153

Adopted Reference Number: EMEA/CHMP/BWP/340831/2009/Rev 1

English (EN) (22.93 KB - PDF)

Prva objava: 10/06/2009 Zadnja posodobitev: 10/06/2009

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European Union recommendations for the seasonal-influenza-vaccine composition for the season 2009 / 2010

Adopted Reference Number: EMEA/CHMP/BWP/133895/2009/Rev 1

English (EN) (28.44 KB - PDF)

Prva objava: 23/04/2009 Zadnja posodobitev: 23/04/2009

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European Union recommendation for the seasonal-influenza-vaccine composition for the season 2008 / 2009

Adopted Reference Number: EMEA/CHMP/BWP/133836/2008

English (EN) (26.4 KB - PDF)

Prva objava: 19/03/2008 Zadnja posodobitev: 19/03/2008

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Biologics Working Party report to the CHMP: Beta-interferons and neutralising antibodies (in multiple sclerosis)

Reference Number: EMEA/CHMP/BWP/580136/2007

English (EN) (37.56 KB - PDF)

Prva objava: 13/02/2008 Zadnja posodobitev: 13/02/2008

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Report: Biologics Working Party, Process Analytical Technologies Group and industry

Reference Number: EMEA/CHMP/BWP/185370/2007

English (EN) (40.37 KB - PDF)

Prva objava: 16/07/2007 Zadnja posodobitev: 16/07/2007

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European Union recommendations for the influenza-vaccine composition for the season 2007 / 2008

Adopted Reference Number: EMEA/CHMP/BWP/108182/07

English (EN) (34.66 KB - PDF)

Prva objava: 19/03/2007 Zadnja posodobitev: 19/03/2007

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European Union recommendations for the influenza-vaccine composition for the season 2006 / 2007

Adopted Reference Number: EMEA/CHMP/BWP/123643/2006

English (EN) (38.03 KB - PDF)

Prva objava: 29/05/2006 Zadnja posodobitev: 29/05/2006

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European Union recommendations for the influenza-vaccine composition for the season 2005 / 2006

Adopted Reference Number: EMEA/BWP/111233/05

English (EN) (25.11 KB - PDF)

Prva objava: 30/03/2005 Zadnja posodobitev: 30/03/2005

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First cases of bovine spongiform encephalopathy in the United States (USA) and Canada: Risk assessment of ruminant materials originating from the USA and Canada

Adopted Reference Number: EMEA/CHMP/BWP/27/04 Legal effective date: 01/07/2004

English (EN) (173.36 KB - PDF)

Prva objava: 21/07/2004 Zadnja posodobitev: 21/07/2004

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European Union recommendations for the influenza-vaccine composition for the season 2004 / 2005

Adopted Reference Number: EMEA/BWP/1104/04

English (EN) (112.37 KB - PDF)

Prva objava: 21/07/2004 Zadnja posodobitev: 21/07/2004

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CPMP position statement on West Nile virus and plasma-derived medicinal products

Adopted Reference Number: EMEA/CPMP/BWP/3752/03/adopted Legal effective date: 25/07/2003

English (EN) (134.87 KB - PDF)

Prva objava: 25/07/2003 Zadnja posodobitev: 25/07/2003

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Final European Union recommendation for influenza-vaccine composition for the season 2003 / 2004

Adopted Reference Number: CPMP/BWP/6011/03

English (EN) (110.33 KB - PDF)

Prva objava: 19/03/2002 Zadnja posodobitev: 19/03/2002

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CPMP position statement - non-remunerated and remunerated donors: safety and suply of plasma-derived medicinal products

Adopted Reference Number: EMEA/CPMP/BWP/1818/02 Final

English (EN) (116.84 KB - PDF)

Prva objava: 30/05/2002 Zadnja posodobitev: 30/05/2002

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European Medicines Agency workshop on the plasma master file, 10-11 October 2001: Summary report

Reference Number: EMEA/CPMP/BWP/173/02

English (EN) (230.52 KB - PDF)

Prva objava: 18/12/2002 Zadnja posodobitev: 18/12/2002

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Final European Union recommendations for the influenza-vaccine composition for the season 2002 / 2003

Adopted Reference Number: CPMP/BWP/852/02

English (EN) (104.27 KB - PDF)

Prva objava: 21/03/2002 Zadnja posodobitev: 21/03/2002

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European Medicines Agency workshop on viral safety of plasma-derived medicinal products with particular focus on non-enveloped viruses, 13 September 2000: Summary report

Adopted Reference Number: CPMP/BWP/BPWG/4080/00

English (EN) (174.45 KB - PDF)

Prva objava: 28/03/2001 Zadnja posodobitev: 28/03/2001

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European Medicines Agency expert meeting on human transmissible spongiform encephalopathies and medicinal products derived from human blood and plasma, 1 December 2000: Summary report

Reference Number: EMEA/CPMP/BWP/450/01

English (EN) (176.07 KB - PDF)

Prva objava: 28/03/2001 Zadnja posodobitev: 28/03/2001

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Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - First version

Adopted Reference Number: EMEA/CPMP/BWP/819/01 Legal effective date: 23/04/2001

English (EN) (59.49 KB - PDF)

Prva objava: 24/04/2001 Zadnja posodobitev: 24/04/2001

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