Pharmacovigilance & Drug Safety

Good Pharmacovigilance Practices

Good pharmacovigilance practices are measures drawn up to facilitate the performance of pharmacovigilance in the European Union. Application of GVP to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities. They include medicines authorised centrally via the Agency as well as medicines authorised at higher level. Pharmacovigilance system defined as the 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 change to their risk-benefit balance.