Pharmacovigilance risk management plans
Risk management plan explains the knowledge about the safety and efficacy of a medicinal product. The RMP gives information on plans for studies and other activities to gain knowledge on the safety and efficacy of the medicine. It also describes measures to be undertaken to minimise risks associated with the use of product in patients. Marketing authorisation holders are required to have an RMP for any new medicinal product for human use that must be submitted at the time of application for marketing authorisation. For nationally authorised products RMPs must be submitted for review and approval.
- Risk Minimisation Measures
- Safety communications
- Marketing authorisation
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Pharmacovigilance risk management plans Conference Speakers
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