When medicines, vaccines or medical device products are suspected of being potentially harmful to users due to their defective quality, safety or efficacy, they may be subjected to recall and all related information must be reported to the Medicines Control Authority of Zimbabwe (MCAZ).
The Medicines Control Authority of Zimbabwe Medicines Products Recall Guidelines is intended to ensure that in the event of a necessary recall, the recall operations are effectively and efficiently carried out by the manufacturer, importer, distributor or certificate holder of a pharmaceutical product (hereafter known as the applicant) in order to safeguard public health.
This guideline describes the following points;
- Introduction and Definitions
- Stages of Recall Procedure
- Assessment of Recall
- Communication to Public