Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances (Annex) - Scientific guideline

This document sets out uniform statements on storage conditions for inclusion in the labelling of medicinal products and to define when they apply. It is intended as an annex to the stability guidelines and relates to marketing authorisations for all product categories other than immunological products.

Keywords: Stability, storage conditions, storage statement, product information, packagel leaflet, labelling, veterinary medicinal product (VMP)

Current effective version

Guideline on declaration of storage conditions: A) in the product information of pharmaceutical veterinary medicinal products B) for active substances

AdoptedLegal effective date: 17/02/2023Reference Number: EMA/CVMP/QWP/857608/2022

Document history

Guideline on declaration of storage conditions: a) in the product information of pharmaceutical veterinary medicinal products b) for active substances annex to guideline on stability testing of new veterinary drug substa...

AdoptedLegal effective date: 31/10/2003Reference Number: EMEA/CVMP/422/99/Rev.3