WHO TRS (Technical Report Series) 908, 2003 Annex 8

Procedure for assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies

WHO, UNICEF, UNAIDS and several other UN organizations are involved in the procurement of drugs. Without a documented quality system in place, organizations could risk sourcing sub-standard, counterfeit and/or contaminated medicines, leading to product complaints and product recalls, waste of money, and most seriously, health risks to patients. WHO is currently undertaking a pilot project which will be used as a model for sourcing pharmaceuticals for other priority diseases. WHO will draft a model quality assessment system for procurement organizations through continued liaison with the relevant organizations. This general procedure for the assessing the acceptability, in principle, of pharmaceutical products for purchase by United Nations agencies is considered to form the basis of the quality assessment system for procurement of pharmaceuticals.

1. Introduction: 

The World Health Organization (WHO) could provide United Nations agencies advice on the acceptability, in principle, of pharmaceutical products which are found to meet WHO recommended quality standards, for purchase by such UN agencies. This will be done through a standardized quality assessment procedure. 

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WHO TRS (Technical Report Series) 908, 2003 Annex 8: