Abstract:
Surveillance activities that occur following market approval of a
medicine, including: maintenance of product authorization and/or
registration of variations or renewals; regular inspections of
manufacturers, wholesalers, distributors, and retailers; quality
control testing; pharmacovigilance; promotion control; public
reporting of poor-quality products; handling of market complaints;
and removal and disposal of non-compliant products. Post-
marketing surveillance is typically considered a key regulatory
function and refers to the set of comprehensive quality surveillance
activities.
