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What is the duration and cost of vaccines prequalification?

FAQ
V

The timeframe for full (standard) assessment takes up to 270 days while the timeframe for streamlined assessment takes up to 90 days. For both full (standard) and streamlined assessment, the time taken by the manufacturer to respond to WHO queries (if needed) will be in addition to these timeframes. 

Fees are incurred for:

  • screening of an application
  • dossier evaluation
  • site inspection
  • annual maintenance.

The fees are based on the type of vaccine and the type of evaluation process that is required. Prequalification fees for "simple" vs. "traditional" vaccines are overall lower compared to those for "combination" or  "novel" vaccines.