The Human Medicines Regulations 2012 No. 1916

PART 11 U.K. Pharmacovigilance

Obligations on holders in relation to pharmacovigilance system U.K.

Obligation on holder to audit pharmacovigilance system U.K.

184.—(1) The holder must—

(a) perform a regular audit of its pharmacovigilance system;

(b) place a note concerning the main findings of each audit on the pharmacovigilance system master file on completion of each audit; and

(c) ensure that an appropriate corrective action plan is prepared and implemented as soon as is reasonably practicable after completion of each audit.

(2) The holder may remove the note placed on the pharmacovigilance system master file under paragraph (1)(b) when all the measures in the corrective action plan under paragraph (1)(c) have been fully implemented.