Risk-based guideline for post-marketing quality surveillance of medicines in Ethiopia

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.