Questions and answers on post approval change management protocols

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Questions and answers

Reference numberEMA/CHMP/CVMP/QWP/586330/2010
Published13/04/2012
Effective from01/10/2012
KeywordsPost approval change management protocol, variation, control strategy
DescriptionThis 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.


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Questions and answers


Draft questions and answers

In operation: 01/10/2012–present


Published: 04/11/2010


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