![]() whenever the risk-management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached.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. ![]() ![]()
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