Contents
Article 16Risk management system#
1.Marketing authorisation holders shall ensure that the pharmacovigilance system includes a risk management system to take appropriate action to minimise identified risks, when necessary.
2.The risk management system shall include a process for monitoring the benefit-risk balance of products and performing signal management. It shall also include a communication system in accordance with Article 20.
3.Marketing authorisation holders shall ensure continuous assessment and document the risk management measures and the outcome of risk minimisation measures in the pharmacovigilance system master file.
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