FAQ
V
Manufacturers of prequalified vaccines are required to observe several post-prequalification commitments and procedures in order to maintain the prequalified status of their vaccine. They must:
- notify WHO of any product variations: all changes that impact product safety or efficacy, alter the basis of regulatory approval or change packaging must be communicated to WHO (and be included in the annual report)
- promptly report any quality and safety complaints to WHO: this includes providing all data reports, batch records and other information to facilitate WHO investigation
- submit annual reports: these must contain, for each prequalified vaccine, a summary of variations made to the product since the previous annual report, testing results from the on-going stability programme, update on implementation of post-prequalification commitments (if any), notification of any problem/constraint in product or quality control, inspections carried out by regulatory bodies, information on production and distribution data, and the Periodic Safety Updated report
- provide sample lots for testing: three to five sample lots to be provided at least once a year, from which samples can be selected for testing to verify continued compliance with prequalification requirements
- facilitate periodic reassessment: provide comprehensive information on the product to enable continued follow-up or monitoring.