WHOPAR Guidance for Applicants

World Health Organization Public Assessment Reports (WHOPAR)  are summaries of the assessment of the product data and information submitted in the product dossier, by the manufacturer, for assessment in the Prequalification Programme. Product assessment reports are published on this WHO Prequalification web page as WHOPARs in response to Resolution WHA57.14 of the World Health Assembly, dated 22 May 2004, which requested the Director-General:

3.(4) to ensure that the prequalification review process and the results of inspection and assessment reports of the listed products, aside from proprietary and confidential information, are publicly available".

 Important to note regarding translations

All information related to prequalified products is provided in English. The supplier should ensure that translations into other languages are of good quality. Translations should be made by qualified medical translators and should be double checked by  the manufacturer or the translation office. A poor quality translation may severely compromise the safety and efficacy of the medicinal product. Therefore, products not complying with this requirement cannot be marketed as prequalified.

 Important note regarding WHOPARs

The product information is an essential part of the medicinal product.  The SmPC and PIL published with the WHOPAR have been quality assured by WHO experts and reflect the situation at the time of publication of the WHOPAR.  These texts, i.e. the SmPC and the PIL are prequalified and should be adhered to.  Generally, a deviation from the prequalified product information (especially as to contents) means the product can no longer be considered to be prequalified.

For more information, see the complete Note below:

• Important note regarding WHOPARs

Related links

• WHOPAR Guidance documents for Applicants

• Overview of WHOPARs of prequalified products