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. Where there is a scientific rationale that an adverse clinical outcome might be associated with off-label use, use in populations not studied, or resulting from the long-term use of the product, the adverse reaction should be considered a potential risk, and if deemed important, should be included in the list of safety concerns as an important potential risk. Important potential risks included in the RMP would usually require further evaluation as part of the pharmacovigilance plan.
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. Where there is a scientific rationale that an adverse clinical outcome might be associated with off-label use, use in populations not studied, or resulting from the long-term use of the product, the adverse reaction should be considered a potential risk, and if deemed important, should be included in the list of safety concerns as an important potential risk. Important potential risks included in the RMP would usually require further evaluation as part of the pharmacovigilance plan.
