Published: 5 September 2014

What are medicine quality complaints?

Prescriber Update 35(3): 40
September 2014

What are medicine quality complaints?

Medicine quality complaints can encompass a wide range of issues identified after medicines have been released for distribution. These issues can affect the identity, quality, durability, reliability, safety or effectiveness of a medicine, which may make it unsafe or unfit for purpose.

Quality complaints can include:

Some examples of complaints reported to Medsafe include:

Who can make a medicines quality complaint to Medsafe?

Complaints relating to the quality of medicines are reported to Medsafe by consumers, pharmacists, wholesalers, prescribers and the pharmaceutical industry.

Medsafe complaint investigation process

Medsafe assesses all complaints received and assigns a priority for review and action based on the perceived degree of risk the to New Zealand public. For example, a serious issue with a widely used prescription medicine will be investigated as a high priority, while a minor issue with website advertising may be treated as a low priority.

Medsafe may request additional information from the relevant parties such as manufacturers, sponsors and reporters if required to proceed with the investigation. They may also seek assistance and/or information from other specialists at Medsafe in relation to good manufacturing practice, pre-market medicines assessment and/or clinical risk assessment to help formulate a decision.

A health risk analysis is performed to assess the potential health impact in New Zealand and to determine the most appropriate action.

Reporting a Problem

When an issue related to the quality of a medicine is identified, it should be reported promptly. This ensures the issue can be investigated and any corrective action, if necessary, can be taken quickly.

Issues related to the quality of specific products can sometimes be an indicator of a larger problem which needs to be addressed immediately. Where applicable, complaint samples should be quarantined and stored in a safe place as these may be required for further testing.

Complaints should be reported to either the Compliance Management Branch at Medsafe, or to the company that distributes the product in New Zealand, or to both.

Questions about the quality complaints process should be directed to the Compliance Management Branch Phone: 04-819-6800 or email

Reports of adverse drug reactions should be reported to the Centre for Adverse Reactions Monitoring (CARM):