Parametric release - Scientific guideline

This document outlines the requirements for applications for veterinary medicinal products in which the use of parametric release is proposed. It highlights the different requirements that have to be fulfilled in such an application and during the inspection, respectively.

Keywords: Parametric release, veterinary medicinal product (VMP)

Current effective version

Guideline on Parametric release

Adopted Reference Number: EMA/CVMP/QWP/339588/2005 – Rev 1 Legal effective date: 17/02/2023

Document history

Guideline on parametric release

Adopted Reference Number: EMEA/CVMP/QWP/339588/2005 Legal effective date: 01/01/2007

Draft guideline on parametric release

Draft: consultation closed Reference Number: EMEA/CVMP/QWP/339588/2005-Cons.

Concept paper on the development of a guideline on parametric release

Reference Number: EMEA/CVMP/QWP/114420/2005