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Call for Applications

Call for Applications

Open calls for applications

There are no current open calls for applications. New calls will be published here.

Inquiries regardings calls for applications that have now closed, or about possible future risk benefit assessment of specific products should be directed to antivenoms@who.int.

Closed calls for applications

Antivenoms for Pakistan, India, Nepal, Bangladesh, Bhutan or Sri Lanka

Polyvalent antivenoms intended for use in the treatment of snakebite envenoming by Bungarus caeruleus, Daboia russelii, Echis carinatus and Naja naja in Pakistan, India, Nepal, Bangladesh, Bhutan, or Sri Lanka.

Closing date: 31st March 2022

The World Health Organization (WHO), acting through its Regulation and Prequalification Department, is now calling for applications from licensed manufacturers of snake antivenom immunoglobulin products who wish to have those products evaluated for potential listing by WHO as recommended for procurement.

The current call applies only to polyvalent snake antivenom immunoglobulin products that are manufactured for the treatment of envenoming by the following species of WHO category 1 medically important snake species:

  • Common krait (Bungarus caeruleus)
  • Russell’s viper (Daboia russelii)
  • Saw-scaled viper (Echis carinatus)
  • Indian cobra (Naja naja)

Products for the treatment of envenoming by these species are typically marketed in Pakistan, India, Nepal, Bangladesh, Bhutan, and Sri Lanka. The call is open to licensed manufacturers and products that are registered and have marketing approval from a competent national regulatory authority. This call relates to products that are primarily intended for the treatment of snakebite envenoming by these species in these countries.

  1. To be eligible for risk-benefit assessment by WHO, an antivenom product must consist of a polyspecific antivenom immunoglobulin preparation, with claimed efficacy in treating envenoming by Bungarus caeruleus, Daboia russelii, Echis carinatus and Naja naja (sometimes referred to as the “big four” species)*.
  2. The manufacturer of the product must submit the specified number of antivenom product samples from at least two (2) batch lots of the product to WHO, along with the specified quantities of each of the immunizing venoms used to manufacture the antivenom. These samples will be comprehensively evaluated in a laboratory by WHO as part of the risk-benefit assessment process.
  3. If the product submitted is determined by WHO to demonstrate a risk-benefit ratio that justifies its use in treating snakebite envenoming, the manufacturer agrees, as a condition of listing, to submit an application for the product to be considered for subsequent WHO prequalification if and when an antivenoms prequalification procedure is established by WHO.
  4. The manufacturer agrees that by submitting an application for risk-benefit assessment, the manufacturer/applicant will be deemed to have accepted and agreed to the eligibility criteria and all of the terms, conditions and other requirements set out in this document.

The manufacturer agrees to provide WHO with post-marketing information (current or future) relevant to the safety and efficacy of the product.

 

* WHO may consider assessing a candidate snake antivenom product that does not meet all the above criteria. In such instances, the application letter and documentation provided to WHO must substantiate the need for the product, and the specific benefit it provides.

Application Process

  1. Manufacturers must first confirm that the product for which they wish to submit an application meets the eligibility criteria listed earlier in this document and read the background information on the preceding pages.
  2. To facilitate assessment planning and logistics to coordinate the shipping of the required venom and antivenom samples, manufacturers are asked to indicate their interest in submitting an application by email to: antivenoms@who.int
  3. All applications must be writing in the format specified further below. The application dossier and other written materials can be submitted in digital format (e.g., Adobe Acrobat *.PDF).
  4. A covering letter must be included with the application. This letter should clearly identify the product, the name and contact details of the manufacturers nominated company representative and indicate acceptance of the terms and conditions of the call for applications, which includes the contents of this document in their entirety.