Part 11 Pharmacovigilance

United Kingdom

1. 177Application of this Part and interpretation
2. Obligations on licensing authority in relation to pharmacovigilance
3. Obligations on holders in relation to pharmacovigilance system
4. Recording, reporting and assessment of pharmacovigilance data
5. Signal detection
6. Periodic Safety Update Reports
7. Urgent action and major safety review
8. Post-authorisation safety studies
9. Medicinal products subject to additional monitoring
10. Transparency and communications
11. Further obligations in respect of pharmacovigilance activities
12. Guidance in respect of pharmacovigilance
13. Enforcement
14. Transitional arrangements