Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline
Table of contents
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
-
List item
Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1 (PDF/314.71 KB)
Adopted
First published: 16/12/2021
Last updated: 19/07/2023
Legal effective date: 01/07/2022
EMA/CVMP/EWP/170208/2005 Rev.1 Corr1 -
List item
Overview of comments received on 'Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1' (PDF/336.83 KB)
First published: 20/12/2021
EMA/CVMP/EWP/524331/2021 -
List item
Draft guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1 (PDF/330.63 KB)
Draft: consultation closed
First published: 23/07/2021
Consultation dates: 23/07/2021 to 30/09/2021
EMA/CVMP/EWP/170208/2005 Rev.1 -
List item
Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics (PDF/217.67 KB)
Draft: consultation closed
First published: 26/04/2021
Consultation dates: 22/04/2021 to 31/05/2021
EMA/CVMP/EWP/165592/2021 -
List item
Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics (PDF/146.37 KB)
Draft: consultation closed
First published: 15/12/2017
Last updated: 15/12/2017
Consultation dates: 15/12/2017 to 31/03/2018
EMA/CVMP/EWP/158889/2017 -
List item
Guideline on the summary of product characteristics for anthelmintics - First version (PDF/96.56 KB)
Adopted
First published: 12/07/2007
Last updated: 12/07/2007
Legal effective date: 01/02/2008
EMEA/CVMP/EWP/170208/2005