Conditions for Acceptance of an Application

An application for prequalification of a candidate vaccine will be accepted for evaluation only if the following conditions are met:

  • the candidate vaccine is on the current vaccines prequalification priority list
  • the candidate vaccine meets the mandatory characteristics for programmatic suitability
  • the national regulatory authority (NRA) responsible for the regulatory oversight of the product must be a classified as a functional NRA or WHO-listed authority operating at maturity level 3 (at a minimum)
  • a marketing authorization has been granted by the relevant NRA and post-marketing regulatory oversight is guaranteed by a responsible NRA (or NRAs).

Vaccine manufacturers who wish to submit a vaccine for prequalification must check with their respective NRA that it has been assessed by WHO and is considered to be functional for a vaccine-exporting country, or assessed and determined to meet the requirements of an NRA operating at maturity level 3 (at a minimum). 

In addition, manufacturers are encouraged to discuss the product and the regulatory requirements with the vaccines assessment group of the WHO Prequalification Team before submission of a an application for evaluation.