Post-prequalification activities |
All lots released by NRA, release certificates to be provided upon request |
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Retention samples for testing by WHO contracted laboratories upon request |
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Reporting of changes (variations) |
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Reporting of changes (variations) with guidance on what and when to report |
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Reassessments based on site visit and testing if needed |
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Reassessment based on fully updated PSF, testing and site visit |
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Provides criteria to define frequency and scope of reassessment requirements. Site visit can be waived if criteria are met, but at least one every five years |
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Frequency and scope of reassessments based on risk analysis |
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Random testing to monitor continued compliance with specifications |
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Introduces requirement for Prequalified Vaccines Annual Reports (PQVARs) |
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Monitoring and investigation of complaints and reports of AEFI |
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Recommendations for action in case of non-compliance |
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