The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed medicines (as well as vitro diagnostics and vaccines) for use primarily during public health emergencies of international concern (PHEICs), but also in other public health emergencies, if appropriate, when communities and public health authorities may be willing to tolerate less certainty about the efficacy and safety of products, given the morbidity and/or mortality of the disease and the lack or paucity of treatment or prevention options. It is intended to provide a time-limited listing for unlicensed products in an emergency context when limited data are available and the products are not yet ready for application for prequalification. 

The EUL is not equivalent or an alternative to WHO prequalification, and should not be thought of as such. The main reason for not qualifying for prequalification is that the product concerned will, at the time of submission for EUL, not fall within the scope of prequalification. WHO Member States alone hold the authority to decide whether or not to allow the emergency use of a medicine in their country.

WHO recognizes the prime importance of conducting and completing clinical trials of any novel product, including when used in a public health emergency. The inclusion of a product in the EUL list does not compromise or otherwise impact ongoing trials.

Eligibility

In order to qualify for an EUL, the medicine must meet the following criteria:

• be intended for a disease that has been declared by WHO's Director-General to be a PHEIC, or judged to be otherwise  in the best interest of public health.
• the disease for which the product is intended is serious or immediately life threatening, causing an outbreak, epidemic or pandemic and for which there is no licensed product for the indication or for a critical subpopulation (e.g. children)
• the product is manufactured in compliance with current good manufacturing practices
• be intended for completion of development and submission for WHO prequalification; ideally, remaining clinical trials and other requisite testing will already be underway at the time of the application for an EUL.

Evaluation procedure

Evaluation will determine whether, in light of available WHO/international standards, the submitted data demonstrate a reasonable likelihood that the medicine's quality, safety and effectiveness are acceptable and that the benefits outweigh the foreseeable risks and uncertainties in the context of a PHEIC.

Duration of validity of an EUL

The validity of an EUL in the context of a public health emergency will generally be for a maximum of12 months. All EUL decisions are reassessed within 12 months (or sooner, if further data or other information become available that could alter the original opinion). When deemed necessary and warranted based on available data and information, the emergency use listing can be extended. Products may have their EUL status removed if new data or information becomes available that changes the benefit‒risk profile of the product, or immediately upon declaration by WHO's Director-General that the relevant PHEIC not longer exists. Manufacturers are required to supply any new information/data to WHO as soon as it becomes available.

WHO reserves the right to:

• terminate an assessment, if the applicant fails to provide WHO with all the required information
• delist a product in case of fraud, misrepresentation, withholding of information by the applicant/manufacturer.

Post-deployment monitoring

For products granted an EUL, appropriate post-EUL monitoring mechanisms should be established to allow for the timely evaluation of adverse events (AEs) and notification to WHO and the relevant national regulatory authorities. If a quality/safety/efficacy issue cannot be resolved to WHO's satisfaction, WHO reserves the right to restrict or revoke the emergency use listing of the product.

Post-EUL changes

Once a product has been listed under the EUL procedure, development of the product should continue to completion for prequalification, whenever possible. Changes to the product proposed after the product has been listed in the EUL, or delisted, should be submitted to WHO. Changes to products listed based on an abridged procedure must have been accepted by the original national regulatory authority responsible for the oversight of the product, and WHO must be notified of the accepted changes. (Some submissions submitted for WHO EUL may have undergone a previous assessment through other emergency mechanisms, for example, the US FDA Emergency Use Authorization process. Where this is the case, it is not the intent of WHO to undertake duplicative work, if the review of the other emergency mechanism is deemed to be of a satisfactory standard.)

Application for an EUL

Since the expectation is that the development of the product submitted for EUL will continue to completion and ultimately submitted for prequalification, the submission for EUL of a medicine should follow the ICH common technical document (CTD) format. In the CTD dossier, sections for which no information is available at the time of the initial submission, should be indicated as "data or information not available", "study ongoing" or "not applicable" as the case may be.

Clarification of specific data requirements may require discussion between the applicant and WHO. Applicants are highly encouraged to contact WHO as early as possible to discuss specifics of their application.

The medicine manufacturer must apply to WHO with the following information:

• manufacturing quality data
• non-clinical data and clinical data
• a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to WHO as soon as the new data are available
• labelling details.

Invitation to manufacturers to submit products for EUL assessment are posted in the Market Information section.