Dossier Review

Information submitted in a product dossier is assessed after submission of proof of payment of the applicable prequalification assessment fee. Assessment of product dossiers is conducted in accordance with standard operating procedures that ensure uniformity in evaluation and timeliness of assessment activities. 

Dossier deficiencies

Any deficiencies in the documentation submitted and/or in the data that are identified in the product dossier review is communicated by WHO in writing to the manufacturer. Thereafter, a corrective action plan that details the amendments required (i.e. responses to be provided to comments, documentation and/or data that is missing and needs to be provided), and deadlines for their submission, must be provided by the manufacturer to WHO. The manufacturer can submit no more than two corrective action plans but only one amendment to the original product dossier will be permitted. Generally, prequalification assessment suspended (i.e. WHO will not undertake any further action) until a corrective action plan has been submitted by the manufacturer and accepted by WHO. In certain cases, WHO may permit the manufacturer to correct specific nonconformities after prequalification provided that the manufacturer commits in writing to correct them by an agreed upon deadline. Such a “commitment to prequalification” will be reflected in the WHO prequalification public report and verified during re-inspection. Failure to comply with prequalification comittments within agreed deadlines will result in the product being delisted from the WHO List of Prequalified In Vitro Diagnostics.

Dossier cancellation

Cancellation of dossier may occur if:

  • it does not meet WHO prequalification requirements or if the manufacturer is not able to, or fails to, provide the required or requested information within a specified deadline; and/or
  • the product does not meet the acceptance criteria for the performance evaluation
  • and/or the manufacturer is not able to, or fails to, implement any corrective actions that WHO may require within a specified deadline
  • and/or the information supplied is inadequate to complete the prequalification assessment in a timely manner.

Consultation with WHO

The manufacturer may request a consultation with WHO to clarify issues identified during dossier review during which WHO may provide technical guidance and specifications to the manufacturer to facilitate compliance with WHO requirements.