Quality aspects of pharmaceutical veterinary medicines for administration via drinking water - Scientific guideline

This document sets out the quality data requirements that are specific to veterinary medicinal products that are administered in drinking water of animals. It also provides guidance for in-use stability testing of these products. 

Keywords: Veterinary medicinal product, biocides, drinking water

Current effective version - under consultation

Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water

Draft: consultation openConsultation dates: 20/06/2025 to 31/10/2025Reference Number: EMA/CVMP/QWP/85848/2025Summary:

This concept paper addresses the need to complement the guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water (EMEA/CVMP/540/03 Rev.1) with information relating to the administration of veterinary medicinal products in liquid feeds.

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Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water

AdoptedReference Number: EMEA/CVMP/540/03 Rev 1Legal effective date: 15/01/2005

Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Annex on compatibility studies between veterinary medicinal products and biocidal products.

AdoptedReference Number: EMA/CVMP/QWP/592906/2022

Overview of comments received on 'Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Annex on compatibility studies between veterinary medicinal products and biocidal products

Document history

Concept paper on the development of a CVMP for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water

Reference Number: EMEA/CVMP/1055/02

Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products

Draft: consultation closedConsultation dates: 01/04/2023 to 30/06/2023Reference Number: EMA/CVMP/QWP/592906/2022