This document sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on the safety features for medicinal products for human use.
Published by EC DG for Health and Food Safety
EMA: Guidance on the format of the risk management plan (RMP) in the EU – in integrated format
General consideration and guidance. This guidance should be read in conjunction with GVP module V. According to GVP module V, the aim of a risk management plan (RMP) is to document the risk management system considered necessary to identify, characterise and minimise the important risks of a medicinal product.