Questions and answers on post approval change management protocols - Scientific guideline

This document describes some general principles about the content and use of post approval change management protocols. It describes how these protocols should be prepared and submitted and explains the procedure for their evaluation. It applies to all medicinal products for human use.

Keywords: Post approval change management protocol, variation, control strategy

Current version

Questions and answers on post approval change management protocols (PACMP) - Revision 1

Adopted Reference Number: EMA/CHMP/QWP/586330/2010 Rev 1 Legal effective date: 15/01/2026

Document history

Questions and answers on post approval change management protocols

Adopted Reference Number: EMA/CHMP/CVMP/QWP/586330/2010 Legal effective date: 01/10/2012

Draft questions and answers on post approval change management protocols

Draft: consultation closed Consultation dates: 14/10/2010 to 28/02/2011 Reference Number: EMA/CHMP/CVMP/QWP/586330/2010