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