Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines - Scientific guideline

This document explains the withdrawal of the note for guidance on the harmonisation of requirements for influenza vaccines and its annex - cell culture inactivated influenza vaccines.

Keywords: Yearly strain update, strain change, seasonal vaccine, clinical trial, core summary of product characteristics (SmPC), effectiveness studies

Current effective version

Explanatory note on the withdrawal of the Note for guidance on harmonisation of requirements for influenza Vaccines and of the core SmPC/PL for inactivated seasonal influenza vaccines

Adopted Reference Number: EMA/CHMP/VWP/40560/2014 Summary:

Twice a year, typically in February for the northern hemisphere and in September for the southern hemisphere, WHO experts meet to decide upon the influenza A and B virus strains that should be recommended for use in the production of influenza vaccine for the coming season.

Document history - First version (current)

Explanatory note on the withdrawal of the Note for guidance on harmonisation of requirements for influenza Vaccines and of the core SmPC/PL for inactivated seasonal influenza vaccines

Adopted Reference Number: EMA/CHMP/VWP/40560/2014 Summary:

Twice a year, typically in February for the northern hemisphere and in September for the southern hemisphere, WHO experts meet to decide upon the influenza A and B virus strains that should be recommended for use in the production of influenza vaccine for the coming season.

Draft explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza Vaccines (CPMP/BWP/214/96) and of the core SmPC/PL for inactivated seasonal influenza vaccines (CMDh/128/2003/Rev5 and CMDh/129/2008/Rev3)

Draft: consultation closed Consultation dates: 01/08/2013 to 31/10/2013 Reference Number: EMA/CHMP/VWP/232674/2013 Summary:

Twice a year, typically in February for the northern hemisphere and in September for the southern hemisphere, World Health Organization experts meet to decide upon the influenza-A and -B-virus strains that should be recommended for use in the production of influenza vaccine for the coming season. For several decades, vaccine manufacturers have been required to conduct small clinical trials with strain-updated seasonal influenza vaccines prior to each flu season and to present the results to competent authorities. Guidance for performing these clinical trials was given in the note for guidance on harmonisation of requirements for influenza vaccines, which has been withdrawn as its content was considered outdated. This explanatory note provides some guidance for the interim period, pending further recommendations from the European Medicines Agency.

Document history - Superseded documents

Note for guidance on harmonisation of requirements for influenza vaccines

Adopted Reference Number: CPMP/BWP/214/96 Legal effective date: 30/04/1997

Cell culture inactivated influenza vaccines - Annex to note for guidance on harmonisation of requirements for influenza vaccines CPMP/BWP/214/96

Adopted Reference Number: CPMP/BWP/2490/00/Adopted Legal effective date: 31/08/2002

Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on on cell-derived influenza vaccines

Reference Number: CPMP/BWP/1764/99