Quality aspects included in the product information for vaccines for human use - Scientific guideline
Table of contents
This document provides guidance on the pharmaceutical data applicable to product information for human vaccines. It covers information to be provided for the summary of product characteristics, labeling and package leaflet.
Keywords: Vaccine, label, summary of product characteristics, patient leaflet, braille
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Guideline on quality aspects included in the product information for vaccines for human use - Revision 1 (PDF/171.39 KB)
Adopted
First published: 07/11/2018
EMA/CHMP/BWP/133540/2017 -
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Overview of comments received on 'Guideline on quality aspects included in the product information for vaccines for human use' (EMA/CHMP/BWP/133540/2017) - Revision 1 (PDF/174.64 KB)
First published: 07/11/2018
EMA/CHMP/BWP/668918/2018 -
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Draft guideline on quality aspects included in the product information for vaccines for human use - Revision 1 (PDF/185 KB)
Draft: consultation closed
First published: 01/02/2018
Last updated: 01/02/2018
Consultation dates: 01/02/2018 to 31/07/2018
EMA/CHMP/BWP/133540/2017 -
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Concept paper on a revision of the guideline on pharmaceutical aspects of the product information for human vaccines (EMEA/CPMP/BWP/2758/02) - Revision 1 (PDF/36.1 KB)
First published: 17/06/2009
Last updated: 17/06/2009
EMEA/CHMP/BWP/290688/2009 -
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Guideline on pharmaceutical aspects of the product information for human vaccines - First version (PDF/194.74 KB)
Adopted
First published: 26/11/2003
Last updated: 26/11/2003
Legal effective date: 01/06/2004
EMEA/CPMP/BWP/2758/02
- Biologicals: finished product
- Multidisciplinary: vaccines
- Directive 2001/83/EC
- Braille requirements for labelling and the package leaflet
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Compilation of QRD decisions on stylistic matters in product information
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Compilation of QRD decisions on use of terms
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Lessons learned from the review of the labelling of centrally authorised pandemic vaccines
- Packaging information of medicinal products for human use authorised by the Union
- Readability of the labelling and package leaflet of medicinal products for human use
- Guideline on summary of product characteristics (SmPC)
- ICH Q1A (R2) Stability testing of new drug substances and products
- Maximum shelf life os sterile products after first opening or following reconstitution
- Stability testing of existing drug substances and products