Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline

The aim of this guideline is to provide SPC guidance mainly in relation to antiparasitic resistance. The guideline indicates which information and recommendations should be included in this respect in the different SPC sections and proposes standard text where appropriate.

This is the first revision of the Guideline on the summary of product characteristics for anthelmintics (EMEA/CVMP/EWP/170208/2005), which initially came into effect in February 2008. The main aim of the revision is to take into account the evolution of antiparasitic resistance in the EU and the scientific knowledge on the factors that significantly influence resistance development..

Keywords: antiparasitic, anthelmintic, ectoparasiticide, resistance, veterinary, SPC, product information

Current version

Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1

AdoptedLegal effective date: 01/07/2022Reference Number: EMA/CVMP/EWP/170208/2005 Rev.1 Corr1

Document history

Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1

AdoptedLegal effective date: 01/07/2022Reference Number: EMA/CVMP/EWP/170208/2005 Rev.1 Corr1

Overview of comments received on 'Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1'

Reference Number: EMA/CVMP/EWP/524331/2021

Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1

Consultation dates: 23/07/2021 to 30/09/2021Draft: consultation closedReference Number: EMA/CVMP/EWP/170208/2005 Rev.1Summary:

This guideline replaces the Guideline on the summary of product characteristics for anthelmintics - First version.

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

Consultation dates: 22/04/2021 to 31/05/2021Draft: consultation closedReference Number: EMA/CVMP/EWP/165592/2021Summary:

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.

Since its introduction in February 2008, the guideline has been applied to most new applications and renewal procedures and possibly also, on the occasion of variations.

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

Consultation dates: 15/12/2017 to 31/03/2018Draft: consultation closedReference Number: EMA/CVMP/EWP/158889/2017Summary:

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.

Guideline on the summary of product characteristics for anthelmintics - First version

AdoptedLegal effective date: 01/02/2008Reference Number: EMEA/CVMP/EWP/170208/2005