Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods

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Download document Concept paper on the revision of the note for guidance on the approach towards harmonisation of withdrawal periods
Reference number EMA/CVMP/SWP/285070/2013
Status draft: consultation open
First published 18/10/2013
Last updated 18/10/2013
Consultation start date 18/10/2013
Consultation end date 31/01/2014
Email address for submissions vet-guidelines@ema.europa.eu

Summary

The Committee for Medicinal Products for Veterinary Use (CVMP) note for guidance: approach towards harmonisation of withdrawal periods was published in 1996. While the approach recommended for dealing with residues below the limit of quantification is simple and easy to apply, more sophisticated methods for dealing with data below the limit of quantification are now available. It is therefore considered that the Safety Working Party should review these alternative methods and, if appropriate, incorporate these into the note for guidance.