MONITORING, KEY INFORMATION & REGULATORY ACTIONS MAY INCLUDE
MONITORING
- MHRA and CHM are responsible for medicine safety monitoring
- Pharmacovigilance database analysis
- Supply status may be modified (OTC/prescription only/pharmacy only)
- Additional monitoring implemented if required
- Prescribing restrictions may be applied
KEY INFORMATION
- Yellow Card reports can be submitted by both practitioners and patients
- Black Triangle products require additional monitoring
- Can lead to changes in product licensing and availability
REGULATORY ACTIONS MAY INCLUDE
- Adding new adverse effects to product information
- Restricting medication use
- Changing supply availability
- Implementation of Black Triangle status