Emergency Use Assessment and Listing Procedure (EUAL) for Candidate in Vitro Diagnostics (IVDs) for Use in the Context of a Public Health Emergency
(2015; 11 pages)

Resumen

The 2014 Ebola outbreak is the largest Ebola epidemic in history, which affected multiple countries in West Africa. This epidemic has demonstrated the need for a WHO emergency use assessment and listing procedure (EUAL) for candidate in vitro diagnostics (IVDs) for use in the context of a public health emergency. The purpose of this extraordinary procedure is to provide guidance to interested UN procurement agencies and national regulatory authorities (NRAs) of relevant WHO Member States. The present document describes the EUAL for candidate IVDs and is primarily aimed at manufacturers of these IVDs in the context of use during a public health emergency. Participation in the procedure is voluntary.

 
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