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Guideline for good clinical practice E6(R2)

1 December 2016. EMA/CHMP/ICH/135/1995. Committee for Human Medicinal Products Guideline for good clinical practice E6(R2). Step 5. Adopted by CHMP for release for consultation 23 July 2015. Start of public consultation 4 August 2015. End of consultation (deadline for comments) 3 February 2016. Final adoption by CHMP 15 December 2016. Date for coming into effect 14 June 2017. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website An agency of the European Union European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. Document History New First Codification History Date Codification November 2005. E6 Approval by the CPMP under Step 3 and release for May 1995 E6. public consultation. E6 Approval by the CPMP under Step 4 and released for July 1996 E6.

Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995 Page 2/70 Document History First Codification History Date New Codification

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