RMPs are continually modified and updated throughout the lifetime of the medicine as new information becomes available. In addition, for nationally authorised medicinal products, any national competent authority (NCA) in the EU can request an RMP whenever there is a concern about a risk affecting the benefit-risk balance of a medicine. For medicines that do not have an RMP, one may be required with any application involving a significant change to the marketing authorisation. In the European Union (EU), companies must submit an RMP to the Agency at the time of application for a marketing authorisation. measuring the effectiveness of risk-minimisation measures.plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine.
how its risks will be prevented or minimised in patients.To help applicants, guidance is available on how to submit RMPs. Companies are required submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation.
