Assessment templates and guidance (veterinary medicines)

The rapporteurs of the Committee for Veterinary Medicinal Products (CVMP) should use the templates and documents provided on this page for the assessment of any new marketing authorisation application for a veterinary medicine under the centralised procedure. For initial marketing authorisation applications, this includes a version of the list of questions and the scientific overview.

The documents below provide general guidance on the evaluation of the quality, safety and efficacy aspects of marketing authorisation applications, for reference purposes.

Assessment reports: principles

Guidance is available for applications relating to veterinary medicinal products in the European Union:

Guideline on the principles for preparing assessment reports for veterinary medicinal products

AdoptedLegal effective date: 01/01/2016Reference Number: EMA/CVMP/450781/2015Summary:

This guideline provides guidance on the principles for the preparation of assessment reports by regulatory authorities for applications relating to veterinary medicinal products in the European Union.

This guidance is aimed to be applicable to all veterinary medicinal products, regardless of authorisation route or type of application.

Assessment reports: guidance

Assessment report templates containing guidance -  in the form of lists of questions (LoQs) - are also available:

• List of questions and scientific overview (biologicals)
• List of questions and scientific overview (non-biologicals)
• List of questions and scientific overview (immunologicals)