WHO TRS (Technical Report Series) 961, 2011 Annex 10


WHO TRS (Technical Report Series) 961, 2011 Annex 10

Procedure for prequalification of pharmaceutical products

1. Introduction:

The World Health Organization (WHO) provides United Nations agencies with advice on the acceptability, in principle, of pharmaceutical products for procurement by such agencies. 

This activity of WHO aims to facilitate access to priority essential medicines that meet WHO-recommended norms and standards of acceptable quality. WHO undertakes a comprehensive evaluation of the quality of pharmaceutical products, based on information submitted by the manufacturers of such products or other applicants, and on an inspection of the corresponding manufacturing facilities and clinical sites. This is done through a standardized procedure which is based on WHO-recommended quality standards. The quality of pharmaceutical products is obviously crucial for the safety and efficacy of such products.

The pharmaceutical products found to meet the WHO-recommended quality standards are included in the list of medicines, as manufactured at the specified manufacturing sites, which are considered to be acceptable, in principle, for procurement by United Nations agencies. The list of prequalified pharmaceutical products is principally intended for use by United Nations agencies — including the Joint United Nations Programme on HIV/AIDS (UNAIDS), United Nations Children’s Fund (UNICEF) and United Nations Population Fund (UNFPA) — to guide their procurement decisions. The growing list of pharmaceutical products that have been found to meet WHO-recommended standards may, however, also be of interest to other organizations and countries wishing to engage in the bulk procurement of pharmaceutical products.

Inclusion in the list does not imply any approval by WHO of the pharmaceutical products and manufacturing sites in question (which is the sole prerogative of national authorities). Moreover, inclusion in the list does not constitute an endorsement or warranty by WHO of the fitness of any product for a particular purpose, including its safety and/or efficacy in the treatment of specific diseases.

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WHO TRS (Technical Report Series) 961, 2011 Annex 10:

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