APPLICANT’S SCREENING CHECKLIST FOR REGISTRATION OF HUMAN VACCINES
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- Create Date September 5, 2026
- Last Updated September 5, 2026
APPLICANT’S SCREENING CHECKLIST FOR REGISTRATION OF HUMAN VACCINES
Purpose: The purpose of this checklist is to assist an applicant to validate an initial application for registration of a human vaccine, verifying that the information required for evaluation of quality, safety and efficacy has been provided to the Pharmacy and Poisons Board. The applicant should ensure that all applicable information is submitted and that items not applicable to the vaccine platform are clearly justified.
Screening note: Items marked NA should be accompanied by an appropriate scientific justification. The checklist is intended for initial dossier completeness screening and should be used together with the applicable PPB requirements and relevant WHO/ICH/SRA guidance for the specific vaccine platform.
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