Section 5 Pharmacovigilance

United Kingdom

1. 73Union pharmacovigilance system
2. 74Union pharmacovigilance database
3. 75Access to the pharmacovigilance database
4. 76Reporting and recording of suspected adverse events
5. 77Pharmacovigilance responsibilities of the marketing authorisation holder
6. 78Qualified person responsible for pharmacovigilance
7. 79Pharmacovigilance responsibilities of the competent authorities and the Agency
8. 80Delegation of tasks by competent authority
9. 81Signal management process