Guideline

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Recommendation on the content of the trial master file and archiving
Internet:	http://ec.europa.eu/health/files/eudralex/vol-10/v10_chap5_en.pdf
Origin/Publisher:	European Commission - Enterprise and Industry Directorate General - Consumer goods - Pharmaceuticals
Content:	This guidance document provides further recommendation on ‘The Trial Master File and Archiving’, including relevant text from CPMP/ICH/135/955 – Note for guidance on Good Clinical Practice.