risk benefit balance
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks [DIR 2001/83/EC Art 1(28a)], i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health [DIR 2001/83/EC Art 1(28)].
- Related Term
- anual re-assessment
- periodic safety update report
- risk
- risk assessment
- risk management plan
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