VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - Scientific guideline

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.

Keywords: VICH, quality, stability testing, climatic zones III and VI, veterinary medicinal products (VMPs), veterinary substance.

Current version

VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version

Reference Number: EMA/CVMP/VICH/335918/2016 Legal effective date: 01/11/2020 Summary:

This guideline has been developed by the appropriate VICH Expert Working Group and has been subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final guideline is recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.

Document history

VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version

Reference Number: EMA/CVMP/VICH/335918/2016 Legal effective date: 01/11/2020 Summary:

This guideline has been developed by the appropriate VICH Expert Working Group and has been subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final guideline is recommended for adoption to the regulatory bodies of the European Union, Japan and the USA.

Draft VICH GL58 Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version

Draft: consultation closed Consultation dates: 27/07/2018 to 31/12/2018 Reference Number: EMA/CVMP/VICH/335918/2016 Legal effective date: 01/06/2019 Summary:

The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.