The RMP should focus on the important identified risks that are likely to have an impact on the risk-benefit balance of the product. An important identified risk to be included in the RMP would usually warrant:
- Further evaluation as part of the pharmacovigilance plan (e.g. to investigate frequency, severity, seriousness and outcome of this risk under normal conditions of use, which populations are particularly at risk);
- Risk minimisation activities: product information advising on specific clinical actions to be taken to minimise the risk, or additional risk minimisation activities.
The RMP should focus on the important identified risks that are likely to have an impact on the risk-benefit balance of the product. An important identified risk to be included in the RMP would usually warrant:
- Further evaluation as part of the pharmacovigilance plan (e.g. to investigate frequency, severity, seriousness and outcome of this risk under normal conditions of use, which populations are particularly at risk);
- Risk minimisation activities: product information advising on specific clinical actions to be taken to minimise the risk, or additional risk minimisation activities.
