Transcription of Q3D Step 5 Elemental impurities
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Q3D Step 5 Elemental impurities
30 Churchill Place Canary Wharf London E14 5EU United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged. 25 July 2016 EMA/CHMP/ICH/353369/2013 Committee for Human Medicinal Products ICH guideline Q3D on Elemental impurities Step 5 Adoption by CHMP for release for consultation June 2013 End of consultation (deadline for comments) 31 December 2013 Final adoption by CHMP December 2014 Date for coming into effect For new marketing authorisation applications: June 2016 For authorised medicinal products: December 2017 ICH guideline Q3D on Elemental impurities EMA/CHMP/ICH/353369/2013 Page 2/84 Document History Code History Date Q3D Approval by the Steering Committee under Step 2a. 6 June 2013 Q3D Approval by the Steering Committee under Step 2b and release for public consultation.
ICH guideline Q3D on elemental impurities EMA/CHMP/ICH/353369/2013 Page 2/84 Document History Code History Date Q3D Approval by …
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