This report includes the following guidelines of direct relevance to the United Nations Prequalification Programme for Priority Essential Medicines and for quality control laboratories: procedures governing the assessment of pharmaceutical products for procurement by United Nations agencies and for assessing the acceptability of quality control laboratories for use by United Nations agencies, as well as guidance on variations to a prequalified product dossier. Adopted also were several monographs for inclusion in The International Pharmacopoeia; in particular for antiretrovirals, including fix