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1
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to
...
understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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Este documento de orientação para elaboração de um plano nacional de operacionalização e vacinação (NDVP) apresenta um esquema que auxilia os países a: desenvolver e atualizar o respectivo NDVP para a introdução de vacinas contra a COVID-19; elaborar estratégias para a operacionalizaçã
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o e o monitoramento da(s) vacina(s) contra a COVID-19 no país; garantir que o plano e o financiamento relacionado estejam bem alinhados a outros planos nacionais de suporte à recuperação e resposta à COVID-19, e que a implementação esteja totalmente integrada nos mecanismos nacionais de governança.Este documento de orientação baseia-se em documentos de orientação já existentes sobre a introdução de novas vacinas, elaborados anteriormente pela OMS mediante consulta com especialistas no assunto, e é embasado por materiais recentes sobre vacinas contra a COVID-19, endossados pelo SAGE OMS
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