Transcription of Annex 4 - who.int
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Annex 4 - who.int
175 Annex 4 Guidelines on procedures and data requirements for changes to approved vaccines1. Introduction 1772. Scope 1783. General considerations 1784. Terminology 1815. Reporting categories for quality changes Major quality changes Moderate quality changes Minor quality changes 1876. Reporting categories for safety, efficacy and/or product labelling information changes Safety and efficacy changes Product labelling information changes Urgent product labelling information changes Administrative product labelling information changes 1907. Procedures Procedures for prior approval supplements Procedures for minor quality changes Procedures for urgent product labelling information changes Procedures for administrative product labelling information changes 1998.
175 Annex 4 Guidelines on procedures and data requirements for changes to approved vaccines 1. Introduction 177 2. Scope 178 3. General considerations 178 4.
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