Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics

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Download document Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics
Reference number EMA/CVMP/EWP/158889/2017
Status draft: consultation open
First published 2017-12-15
Last updated 2017-12-15
Consultation start date 2017-12-15
Consultation end date 2018-03-31
Email address for submissions vet-guidelines@ema.europa.eu

Summary

The current guideline on the Summary of Product Characteristics (SPC) for anthelmintics (EMEA/CVMP/EWP/170208/2005) recommends standard warnings aimed at delaying the development of anthelmintic resistance. The scope of the guideline is currently limited to products for sheep, goats, cattle and horses, and proposes standard text for sections 4.4 and 4.9 of the SPC. The scope of the guideline should be extended to host species other than ruminants and horses, e.g. to pigs and companion animals. In those additional species, resistance emergence is reported in some helminths in given geographical areas.