Reduction, elimination or substitution of thiomersal in vaccines
|Current effective version|
|Keywords||Thiomersal, vaccines, substitution, elimination, preservative, reduction, comparability, antigenicity, stability, organomercurial|
This document concerns the use in vaccines of the antimicrobal preservative thiomersal. It provides general guidance on the reduction, elimination and substitution of this compound, considering quality, efficacy and safety aspects.
A 2016 review of this guideline concluded that it remains up-to-date and relevant.
- Directive 2001/83/EC
- Regulation (EC) No 726/2004
- ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products
- Pharmaceutical and biological aspects of combined vaccines
- Thiomersal: implementation of the warning statement relating to sensitisation