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MCA-GL-120, Annex 5b

EUA Annex 5b — Recipients Information
GambiaMedicines Control Agency, The GambiaRegistrationCurrentness under review
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Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

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EUA Annex 5b — Recipients Information is published by Medicines Control Agency, The Gambia. This document is identified by its title; no separate official document code is recorded.

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MCA-GL-120, Annex 5b
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About this regulation

EUA Annex 5b — Recipients Information

Recipient information template for emergency use authorisation, including in vitro diagnostics under the parent guideline. It provides fields for the declared emergency, intended use, emergency authorisation conditions, benefits and risks, alternatives, recipient choice, adverse events and new findings. The product and dosing wording is retained from the original template.

This document is identified by its title; no separate official document code is recorded. Always confirm the current consolidated text and transition provisions with the official source before filing.