Transcription of Annex 6 - WHO | World Health Organization
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Annex 6 - WHO | World Health Organization
315 Annex 6 Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agenciesAbbreviations 3171. Introduction 3172. Conditions for acceptance of applications 3193. Steps of the procedure Official request and response Meetings with manufacturers Product summary file Initial testing of vaccine samples WHO site audits Report and outcome of the assessment 3274. Considerations for streamlining the prequalification procedure on the basis of enhanced assistance by NRAs Procedure for selecting eligible NRAs Streamlined procedure for vaccines with marketing authorization/licensing granted by eligible NRAs Vaccines with positive scientific opinion issued by the EMA 3335.
Annex 6 317 Abbreviations AEFI adverse event following immunization AMC Advance Market Commitment CHMP Committee for Medicinal Products for Human Use
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