Anthelmintic resistance - Scientific guideline

This document discusses different ascpects related to anthelmintic resistance. It provides guidance on methods of detecting resistance and gives recommendation on how the information about resistance should be worded in the summary of product characteristics.

Keywords: Anthelmintic resistance, anthelmintics, helminth infestation, nematodes, trematodes, cestodes, veterinary medicinal product (VMP)

Current effective version

Reflection paper on anthelmintic resistance

Adopted Reference Number: EMA/CVMP/EWP/573536/2013

Document history

Reflection paper on anthelmintic resistance

Adopted Reference Number: EMA/CVMP/EWP/573536/2013

Reflection paper on anthelmintic resistance

Draft: consultation closed Consultation dates: 29/04/2016 to 31/07/2016 Reference Number: CVMP/EWP/573536/2013 Summary:

Helminth infestations are common in most animals. Usually, there is a balance between helminth infestation and the immune system of the animal and thus helminths may not lead to clinical signs of disease.

Overview of comments received on the 'Reflection paper on anthelmintic resistance’

Reference Number: EMA/CVMP/EWP/526298/2016-Rev.1

Reflection paper on anthelmintic resistance

Draft: consultation closed Consultation dates: 23/04/2014 to 31/07/2014 Reference Number: EMA/CVMP/EWP/573536/2013 Summary:

Helminth infections are common in most animals. Usually, a balance exists between helminths and the immune system of the animal and thus helminth infection will not lead to illness. However, in animals that do not have sufficient immunity against worms e.g. young or diseased individuals, or when exposure to eggs/larva is massive, helminth infections may have severe impact on the health status. This might subsequently impact on performance (e.g. racing horses) and production (e.g. reduced milk and weight gain in sheep).