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.
Recommendations in this guidance are of an editorial nature and should be implemented in the RMP during the scientific review of a medicinal product, prior to the opinion of the Committee for Medicinal Products for Human Use (CHMP) and adoption of the final RMP version. Changes not implemented before approval (at the time of CHMP opinion) should be considered for redaction post-approval, with a view of publishing the RMP on the European Medicines Agency (EMA) product page…
