Transcription of Guideline on assessment and control of DNA reactive ...
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Guideline on assessment and control of DNA reactive ...
6 December 2018. EMA/CVMP/SWP/377245/2016. Committee for Medicinal Products for Veterinary Use (CVMP). Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products Agreed by Safety Working Party (SWP-V) November 2016. Agreed by Efficacy Working Party (EWP-V) December 2016. Agreed by Quality Working Party (QWP) February 2017. Adoption by CVMP for release for consultation 16 February 2017. Start of public consultation 24 February 2017. End of consultation (deadline for comments) 31 August 2017. Agreed by EWP-V 30 May 2018. Agreed by QWP 28 September 2018. Agreed by SWP-V 23 October 2018. Adoption by CVMP 6 December 2018.
of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk which was used as a template, with amendments introduced in order to cover the issues specific to VM Ps. 2. Scope of guideline This document is intended to provide guidance for new veterinary drug substances and new VMPs,
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