Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated format. The revision will result in concise, scientifically focussed and riskproportionate documents and is applicable to all sections of the RMP, especially sections that have become overly lengthy over time and often duplicate information presented elsewhere in the dossier or in other documents, such as the periodic safety update report.