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Eudralex Volume 10 Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95)

Short Title:

ICH/ European Commission

Document Type:
This note for guidance concerns the application of Part 4, sections B and C of the Annex to Directive 75/318/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It established the principles for standards of Good Clinical Practice both within the European Community and within the ICH regions. It replaces the previous 1990 guideline entitled Good Clinical Practice for Trials on Medicinal Products in the European Community (III/3976/88), adopted May 1990.

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