MEB 45: National implementation of additional risk minimisation measures
An important element of a risk management plan (RMP) is a clear description of the necessary measures in order to minimise the risks when using the medicinal product. A distinction is made between routine risk minimisation measures, and additional risk minimisation measures.
- GVP Module XVI Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2)
- European Medicines Agency's Working Group on Quality Review of Documents (QRD) Product information templates
- Guideline on the readability of the labelling and package leaflet of medicinal products for human use