Spring Intro 2023

Jenny Lamport

Types of application

Full applications (i.e. complete dossier) ● New or known active substances – Article 8(3) – Company data (+ published data) ● Well established use – Article 10a – Published data

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New active substance

 ‘First’ EU application  Starts the ‘global marketing authorisation’ ● Relevant for data exclusivity and market protection

● https://ec.europa.eu/health/sites/health/files/files/eudralex/vol 2/vol2a_chap1_en.pdf [Annex I gives definition of new active substance}

● Also reflection paper https://www.ema.europa.eu/en/chemical-structure-properties-criteria-be considered-evaluation-new-active-substance-nas-status

The Organisation for Professionals in Regulatory Affairs

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