WHO Regulation and Prequalification

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1. Emergency use listing (EUL)
   1. Covid-19 Vaccines
   2. Ebola Virus Disease Vaccines
   3. Poliomelytis (Polio) vaccines
   4. Emergency Use Listing Procedure for vaccines

Emergency use listing

The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency. This will assist interested UN procurement agencies and Member States in determining the acceptability of using specific products, based on an essential set of available quality, safety, and efficacy and performance data.

The procedure is a key tool for companies wishing to submit their products for use during health emergencies.

Eligibility of candidate products

The EUL concerns three product streams (vaccines, therapeutics and in vitro diagnostics), each of which has specific requirements for products to be eligible for evaluation under the EUL procedure.

The following criteria must be met:

• The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an EUL assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children);
• Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines);
• The product is manufactured in compliance with current Good Manufacturing Practices (cGMP) in the case of medicines and vaccines and under a functional Quality Management System (QMS) in the case of IVDs; and
• The applicant undertakes to complete the development of the product (validation and verification of the product in the case of IVDs) and apply for WHO prequalification once the product is licensed.

Information on EUL vaccines

More information can be found here. 

The contact email for Vaccines EUL submissions and more information is whoeul@who.int

Information on EUL in vitro diagnostics

Instructions for manufacturers detailing the technical specifications for the documentary evidence can be found  here.  

The contact email for IVDs EUL submissions and more information is diagnostics@who.int

 

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https://cdn.who.int/media/docs/default-source/medicines/eulprocedure.pdf?sfvrsn=55fe3ab8_8&download=true

8 JANUARY 2020

Emergency use listing procedure

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