WHO prequalification evolved from three separate programmes (i.e. vaccines, in vitro diagnostics, medicines) which share a common aim: ensuring that vital health products meet quality standards. Since its inception, nongovernmental organizations, UN procurement agencies and regulatory authorities in recipient countries, have both supported WHO prequalification and benefited from it. Over the years WHO Prequalification has further expanded and today, close to 1,500 products — in vitro diagnostics (IVDs), male circumcision devices, medicines, vaccines, immunization devices, cold chain equipment, and vector control products —are prequalified and have assisted in improving public health in low- and middle-income countries (LMIC). WHO prequalification has become a trusted and reputed symbol for safety, quality and efficacy across stakeholders.

WHO Prequalification outputs of value to procurement agencies include but are not limited to:

• WHO Catalogue of Prequalified Immunization Devices
• List of prequalified in vitro diagnostic products
• List of prequalified male circumcision devices
• List of prequalified finished pharmaceutical products
• List of prequalified active pharmaceutical ingredients
• List of prequalified quality control laboratories
• List of prequalified vaccines
• List of prequalified vector control products

When purchasing products from these lists, the procurement agency should ensure that:

• the most current edition of the list is used
• the contracted manufacturer will supply the product as prequalified in all aspects in the product dossier that was assessed by WHO and as detailed in the WHO Public Report
• the product supplied by the manufacturer was manufactured at the site as listed in the product dossier assessed by WHO and inspected by WHO (and as appears on the list)
• the compliance status of the manufacturer with good practices is valid at the time of procurement.

WHO recommends that procurement agencies enter into an agreement or contract with the manufacturer before purchasing any products. Roles and responsibilities of each party should be clearly defined in the agreement. The agreement should make provision for liability and remedies in case of breach of contract. WHO also recommends that procurement agencies perform other aspects of qualification before purchasing products, such as ensuring financial stability and standing of the supplier, ability to supply the required quantities and other related aspects, including the registration status of the products they wish to procure.