Call for Applications
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.
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.
- 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.
- 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: firstname.lastname@example.org
- 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).
- 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.