Prequalification Reports

Each dossier review report, clinical evidence review report, manufacturing site(s) inspection report and labelling review report is finalized according to the relevant standard operating procedures and format established by WHO, describing the findings and including requests and recommendations to the manufacturer. The assessment report will be communicated in writing to the manufacturer. If any additional information is required, or if corrective action has to be taken by the manufacturer, WHO will postpone its decision on the acceptability of the product and/or manufacturing site(s) concerned until, as applicable:

  • such information has been provided by the manufacturer, assessed and found satisfactory by WHO
  • and/or such corrective action has been taken by the manufacturer and found satisfactory by WHO, in light of the specified standards.

As WHO is responsible for the prequalification assessment process, the ownership of the reports arising from or relating to the prequalification assessment process lies with WHO. Thus, WHO shall be entitled to use and publish such reports subject always, however, to the protection of any commercially-sensitive confidential information of the manufacturer. Confidential information in this context means:

  • confidential intellectual property, know-how, and trade secrets (including, e.g. formulas, processes or information contained or embodied in a product, unpublished aspects of trademarks, patents, etc.)
  • commercial confidences (e.g. structures and development plans of a company).

Subject to the protection of commercially-sensitive confidential information, WHO will publish on this website and make publicly available the following information in connection with the prequalification assessment process:

  • names of products and of manufacturers that have applied for prequalification
  • the product code(s) submitted for prequalification
  • the prequalification status of each application
  • a WHO prequalification Public Report summarizing the findings of the prequalification assessment (including the findings from the dossier review, clinical evidence review and manufacturing site(s) inspection)
  • any negative outcomes of the prequalification assessment, including product alerts such as WHO information notices for users, WHO notices of suspension and/or WHO Notices of Concern.

Notwithstanding any of the foregoing, 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, in accordance with relevant 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 – of the prequalification assessment process including, but not limited to, the dossier review, clinical evidence review and/or manufacturing site inspection, and including any confidential information to which WHO may gain access in the course of the prequalification process.

Public Reports

A WHO Prequalification Public Report is posted on this website for each in vitro diagnostic (IVD) and MCD as soon as it has been prequalified. Each report summarizes the assessment carried out for the IVD, as well as any inspection of the manufacturing site(s) that manufacture that product. 

In the near future, for each IVD and MCD prequalified, a separate Public Assessment Report and a separate Public Inspection Report will be posted on this website. Some Public Inspection Reports are already available for some products. 

Prequalification Public Peports are key prequalification outputs, providing insight into prequalification processes and helping to ensure that those processes are transparent. Other key prequalification outputs for IVDs include the WHO List of Prequalified In Vitro Diagnostic Products.