V.B.12. Quality systems and record management

Although many experts may be involved in writing the RMP, the final responsibility for its quality, accuracy and scientific integrity lies with the marketing authorisation applicant/holder. As such the QPPV should be aware of, and have sufficient authority over the content. The marketing authorisation holder is responsible for updating the RMP when new information becomes available and should apply the quality principles detailed in GVP Module I. The marketing authorisation holder should maintain records of when RMPs were submitted to competent authorities and the significant changes between RMP versions. These records, the RMPs and any documents relating to information within the RMP may be subject to audit and inspection by pharmacovigilance inspectors.