How do I apply for prequalification of an immunization product or device?

Any manufacturer of an immunization-related product or device (hereafter, “product”) may apply for prequalification of a product that belongs to a product category that WHO prequalifies. In the first instance, WHO prequalifies products that are offered by the legal manufacturer of the product. Products offered by a reseller may also be considered for prequalification if a formal licensing arrangement exists with the legal manufacturer.

The full product prequalification procedure consists of three stages for product manufacturers:

• completion and submission of a presubmission form
• product dossier evaluation  and product testing
• annual post-prequalification re-evaluation to ensure a product’s continued compliance with WHO prequalification standards.