Definition according to GVP Annex I (Rev 3):
An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.
Explanatory wording provided in GVP module V (Rev 2):
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 important potential risks to be included in the RMP are those important potential risks that, when further characterised and if confirmed, would have an impact on the risk-benefit balance of the medicinal product.
