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CxMP adopted - European Medicines Agency

Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An Agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency , 2020. Reproduction is authorised provided the source is acknowledged. 20 July 2020 EMA/CHMP/CVMP/QWP/496873/2018 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Guideline on the quality of water for pharmaceutical use Draft agreed by Quality Working Party 7 June 2018 adopted by CHMP for release for consultation 28 June 2018 adopted by CVMP for release for consultation 19 July 2018 Start of public consultation 15 November 2018 End of consultation (deadline for comments) 15 May 2019 Agreed by GMDP IWG 5

The no te for guidance has been updated to reflect the following changes in the European Pharmacopoeia: • revised monograph for Water for Injections (0169) allowing the possibility to use methods other than

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