EMA - Publication of the Guidance on the anonymisation of protected personal data and assessment of commercially confidential information during the preparation of RMPs (main body and annexes 4 and 6)

This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI) when drafting risk management plans (RMPs) in the pre-approval process, and for the redaction of the RMPs for publication post-approval. More information on the risk management plans on the EMA Website.