(2003; 148 pages)
2.11 Monitoring of Complaint(s)
Complaint(s) concerning a pharmaceutical product(s) or batch of product(s) supplied by the manufacturer, communicated to WHO, will be investigated in accordance with an SOP established by WHO.
After investigation, WHO will provide a written report of the problem and include recommendations for action where relevant.
A copy of the report will be sent to the DRA of the country where the manufacturing site is located. The DRA could be invited to participate in the investigation of the complaint.
WHO will make a copy of the report available to the manufacturer.