Questions and answers on post approval change management protocols

This guideline applies to human and veterinary medicines.

Current effective version

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Reference number EMA/CHMP/CVMP/QWP/586330/2010
Published 13/04/2012
Effective from 01/10/2012
Keywords Post approval change management protocol, variation, control strategy
Description This document describes some general principles about the content and future use of the 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 and veterinary use.

Document history

First version

Current version

PDF iconQuestions and answers


PDF iconDraft questions and answers

In operation: 01/10/2012–present


Published: 04/11/2010

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