Guidelines for the Notification of Medicinal Product Problem or Defect and Recall Procedure in Zimbabwe.

The purpose of these Guidelines is to ensure effective and efficient recall operations are carried out in respect of defective and harmful medicines, vaccines or medical device products. They apply to all parties involved in different stages of the supply chain of medical products including manufacturers and wholesalers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees. The Guidelines contain steps to be followed in case of substandard or falsified products. A five stage recall procedure is set out along with the various ways in which the recall process may be initiated. Guidance is included on the information required for assessment of recall, recall strategy, classification of recall, level of recall and the communication in respect of recall. The responsibilities of different stakeholders in respect of product recall are explained. Guidance for post recall actions such as evaluation of recall and reinstatement of supply is also provided.