FAQ
V
Any manufacturer of a vaccine that fulfils two preconditions may submit an application for prequalification:
- the vaccine is included on the priority list
- the national regulatory authority (NRA) responsible for regulatory oversight in the vaccine’s country of manufacture is confirmed as functional or with the required “maturity level” as per the WHO Global Benchmarking Tool.
If these conditions are met, the manufacturer may apply for prequalification by:
- communicating its intention to submit a vaccine for evaluation as early as possible, by sending an official letter of intent to WHO
- attending a pre-evaluation meeting with the WHO and the responsible NRA if necessary
- submitting a comprehensive application information in the form of a WHO Vaccine Prequalification Dossier which is based, in structure and content, on the International Conference of Harmonization (ICH) common technical document
- providing an appropriate number of vaccine samples for WHO independent testing, accompanied by lot summary protocols.