Transcription of ICH guideline Q3D (R1) on elemental impurities
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ICH guideline Q3D (R1) on elemental impurities
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, 2019. Reproduction is authorised provided the source is acknowledged. 28 March 2019 EMA/CHMP/ICH/353369/2013 Committee for Human Medicinal Products ICH guideline Q3D (R1) on elemental impurities Step 5 Transmission to CHMP 26 April 2018 Adoption by CHMP 26 April 2018 Release for public consultation 26 April 2018 End of consultation on the Cadmium Inhalation PDE (deadline for comments) 26 July 2018 Final adoption by CHMP 28 March 2019 INTERNATIONAL COUNCIL FOR harmonisation OF technical REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED guideline guideline FOR elemental impurities Q3D(R1)
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED GUIDELINE. G. UIDELINE FOR . E. LEMENTAL . I. MPURITIES. Q3D(R1) Final version Adopted on 22 March 2019 This Guideline has been developed by the appropriate ICH Expert Working Group and
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