Transcription of Reflection paper on the dissolution specification for ...
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Reflection paper on the dissolution specification for ...
10 August 2017. EMA/CHMP/CVMP/QWP/336031/2017. Committee for Medicinal Products for Human use (CHMP). Committee for Medicinal Products for Veterinary use (CVMP). Quality Working Party (QWP). Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action Draft agreed by the QWP March 2016. Draft adopted by the CHMP for release for consultation March 2016. Draft adopted by the CVMP for release for consultation April 2016. Start of public consultation 13 May 2016. End of consultation (deadline for comments) 13 August 2016. Agreed by the QWP 24 May 2017. Adopted by the CHMP June 2017. Adopted by the CVMP July 2017. Keywords dissolution specification , Generic, Oral immediate release product 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555.
1.1. Scope In the context of this reflection paper immediate release is identified as at least 75% (Q) of the active substance is dissolved within 45 minutes.
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