Submission and Handling of Complaints submitted to WHO related to Prequalified VCPs 
WHO will review any complaint concerning a prequalified vector control product (VCP) that is communicated to WHO by end users, national authorities and their implementing partners, procurement agencies or by manufacturers. Complaints can be submitted by sending an email to WHO identifying the product, description of the issue and any available supporting documentation.

Complaints should be submitted to WHO by email via rapidalert@who.int.

Upon submission, WHO will acknowledge receipt of the complaint and determine if it is within the scope of WHO.  For those complaints not related to prequalified VCPs, the reporter will be informed that the complaint is outside the scope of WHO and that no investigation will be reviewed by WHO.  In such cases, reporters are encouraged to contact the responsible manufacturer and, if appropriate, the responsible national regulatory authority(ies).  Complaints related to the falsification of prequalified VCPs are within the scope of WHO complaint handling. 

For those complaints which are within scope of WHO, an investigation will be initiated. Firstly, WHO will notify the manufacturer of the relevant product(s) and, depending on the nature of the complaint, may also notify national regulatory authorities, other relevant authorities of any interested WHO Member State and/or interested UN agencies of the complaint. 

Depending upon the severity of the complaint(s), WHO may determine that it is necessary to issue a suspension of the prequalification pending the outcome of investigation.

The manufacturer of the product will be contacted and requested to submit an investigation report and supporting information which is relevant such as manufacturing records, testing reports on distributed and retained batch samples, photographic evidence, etc.   This should include:
•    Root cause analysis (how/why did this happen); 
•    Analysis regarding related areas (is this same issue impacting/occurring elsewhere); 
•    Correction (fix now) with completion dates; 
•    Corrective action, if application (to prevent recurrence) with planned completion dates

Upon receipt, WHO will review the available information and determine if the investigation and identified/implemented corrective actions are based on documented procedures, are timely and follow good risk management principles.  WHO may identify any additional activities/information to be required as part of the investigation. This may include, but is not limited to, on-site inspection(s), submission of PPQC change applications, and/or additional product testing.

In accordance with the procedures presented in the Overview of the WHO Prequalification Assessment of Vector Control Products, based on the findings of the investigation, WHO may determine that it is necessary to issue a suspension of the prequalification until the identified issues are addressed or product is brought into compliance. Alternatively, WHO may determine that the product should be delisted and removed from the list of prequalified VCPs. 

If serious or critical nonconformities or concerns (including with respect to quality, safety and/or efficacy) are identified in connection with the prequalification assessment of a product and/or a prequalified product, WHO reserves the right to use, publish, issue, share with relevant authorities of WHO Member States as well as with UN agencies and other relevant intergovernmental organizations, and/or make publicly available (in each case, pursuant to the provisions of this document, including provisions regarding the protection of any commercially sensitive information of the manufacturer) any outcomes, reports, notices and/or results, whether in draft or final form, and whether positive or negative, arising from or relating to the prequalification assessment process and/or prequalified product. This includes, without limitation, any WHO Notices of Concern, WHO Notices of Suspension and WHO Information Notice to end users. Consequently, WHO may delist the product after evaluation of the evidence and risk-benefit assessment or may suspend the product until results of further investigations become available and are assessed by WHO. WHO may re-list the product only after the aforementioned evidence, risk-benefit and other assessments, and investigation results are considered acceptable by WHO.