pharmacovigilance system
- Guideline or reference source
- HMAGVP Guideline on good pharmacovigilance practices
- Definition
- A system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. In general, a pharmacovigilance system is a system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance.
- Related Term
- pharmacovigilance system master file
- quality of a pharmacovigilance system
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