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How long does prequalification of an immunization device take?

FAQ
ID

Presubmission

WHO will contact the manufacturer within one month after receiving a complete presubmission form inviting it to submit a product dossier that meets the requirements of the relevant product performance specification.

Dossier review and decision

WHO will contact the manufacturer within one or two months of receiving the product application dossier depending on the number of clarification questions raised by the dossier review team.

Dossier reviews are carried out once per month.

  • dossiers received on or before 1st Tuesday of any month will be assessed on 4th Tuesday and/or Thursday of that month
  • dossiers submitted after 1st Tuesday of every month will be evaluated 4th Tuesday and/or Thursday of the following month.