What is a product complaint?
A written, electronic, or oral notification of a suspected defect in the quality, identity, shelf life, reliability, safety or presentation of a finished medicinal product, or of an accompanying device supplied for its administration, after it has been placed on the market or used in clinical studies.
 
Examples of product complaints include (but are not limited to):

• Defects in the container and outer packaging
• Defects in labelling or in the package insert
• An unexpected, visually recognizable change in the appearance of the product, container, packaging
• Difficulties in the proper use of the accompanying devices for administering the product
• Incorrect, incomplete or inaccurate materials

When reporting product complaints, please provide the following information in your report to ensure sufficient information is received to direct the investigation:

• Product name of the vaccine or medication
• Batch number
• Cause for complaint (defect/event)
• Date of occurrence
• Number of units / packages complained
• If the sample is available
• Consent for follow up
• Contact details