Drug EMEA Regulator Publishes Core SPC for Pandemic Influenza Vaccines
Two guidelines have been developed by the Vaccine Working Party (VWP) on Pandemic
Influenza vaccines:
- Guideline on dossier structure and content for marketing authorisations for pandemic
influenza vaccines (EMEA/CPMP/VEG/4717/03 Rev-1);
- Guideline on submission of marketing authorisation applications for pandemic
influenza vaccines through the centralised procedure (EMEA/CPMP/VEG/4986/03).
This harmonised SPC has been developed by the VWP in order to facilitate the submission of
the core pandemic dossier and subsequent approval of the pandemic variation: the SPC, based
upon this harmonised SPC proposal, labels and package leaflet approved in the core pandemic
dossier authorisation will normally not have to change (except for some information on the
pandemic strain) when the pandemic variation is submitted. It is intended solely for
inactivated pandemic virus derived vaccines. Please note that the text proposal should be
considered as a minimum requirement. Additional claims should be substantiated with data.
It should be read in conjunction with the following additional guidance documents:
- Guideline on Summary of Product Characteristics, published by the European
Commission
- Guideline on Pharmaceutical aspects of the product information for human vaccines
(EMEA/CPMP/BWP/2758/02)
- QRD Product Information Template with explanatory notes
- Convention to be followed for QRD Templates
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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