[F1CHAPTER IIU.K.Minimum requirements for the quality systems for the performance of pharmacovigilance activities

Section 1U.K.General provisions

Article 9U.K.Performance indicators

1.The marketing authorisation holder, national competent authorities and the Agency may use performance indicators to continuously monitor the good performance of pharmacovigilance activities.

2.The Agency may publish a list of performance indicators on the basis of a recommendation of the Pharmacovigilance Risk Assessment Committee.]

Textual Amendments