SCHEDULES

F1SCHEDULE 12AFurther provision as to the performance of pharmacovigilance activities

Annotations:

PART 2Minimum requirements for the quality systems for the performance of pharmacovigilance activities by the licensing authority and holders

Performance indicators9

1

The holder and the licensing authority may use performance indicators to continuously monitor the good performance of pharmacovigilance activities.

2

The licensing authority may publish a list of performance indicators.