S.L. 458.35 Art. 12Authority not precluded from charging fees.

Regulation 11 shall not preclude the Authority from charging fees to marketing authorisation holders for performing those activities by the Authority on the condition that its independence in the performance of those pharmacovigilance activities is strictly guaranteed.

Marketing authorisation holders shall pay fees for pharmacovigilance obligations as levied under the Medicines

Authority (Fees) Regulations).