Transcription of Q3C (R8) Step 5 - impurities: guideline for residual solvents
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Q3C (R8) Step 5 - impurities: guideline for residual solvents
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The NetherlandsAn agency of the European UnionAddress for visits and deliveries Refer to Send us a question Go to +31 (0)88 781 6000 European Medicines Agency, 2021. Reproduction is authorised provided the source is May 2021 EMA/CHMP/ICH/82260/2006 Committee for Medicinal Products for Human Use ICH guideline Q3C (R8) on impurities : guideline for residual solvents step 5 Transmission to CHMP 30 April 2020 Adoption by CHMP 30 April 2020 Release for public consultation 4 May 2020 Deadline for comments 30 July 2020 Final adoption by CHMP 20 May 2021 Date for coming into effect 20 November 2021 ICH guideline Q3C (R8) on impurities : guideline for residual solvents EMA/CHMP/ICH/82260/2006 Page 2/51 Document History Code History Date Parent guideline : impurities : guideline for residual solvents Q3C Approval by the Steering Committee under step 2 and release for public consultation.
Step 5 . Transmission to CHMP 30 April 2020 Adoption by CHMP 30 April 2020 Release for public consultation 4 May 2020 Deadline for comments 30 July 2020 Final adoption by CHMP 20 May 2021 Date for coming into effect 20 November 2021 . ICH guideline Q3C (R8) on impurities: guideline for residual solvents
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