Questions and answers on post approval change management protocols - Scientific guideline
This guideline applies to human and veterinary medicines.
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.
Keywords: Post approval change management protocol, variation, control strategy
Questions and answers on post approval change management protocols (PDF/111.68 KB)
First published: 13/04/2012
Last updated: 13/04/2012
Consultation dates: 15/03/2012 to 31/10/2012
Draft questions and answers on post approval change management protocols (PDF/95.66 KB)Draft: consultation closed
First published: 04/11/2010
Last updated: 04/11/2010
Consultation dates: 14/10/2010 to 28/02/2011