Who can participate in WHO prequalification of immunization devices?

Any manufacturer of an immunization-related product or device (hereafter, "product") belonging to a category that WHO prequalifies can submit a product for prequalification. Specifically, 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 has been made with the legal manufacturer.

What categories of products can be prequalified?

WHO prequalifies products and devices belonging to the following categories:

• E001: Cold rooms, freezer rooms & related equipment
• E002: Refrigerated vehicles
• E003: Refrigerators and freezers
• E004: Insulated containers
• E005: Insulated containers
• E006: Temperature monitoring devices
• E007: Cold chain accessories
• E008: Single-use injection devices
• E010: Waste management equipment
• E013: Therapeutic injection devices

Products in any of these categories may be submitted for prequalification.

Developers and manufacturers of product in these categories might also wish to refer to the WHO target product profiles (TPPs). TPPs describe desired future features and characteristics that will, over time, become incorporated into product specifications as requirements.

How are products prequalified?

The full product prequalification procedure consists of three stages:

• completion of a pre-submission form
• product dossier evaluation and product testing
• annual post-prequalification re-evaluation to ensure that the prequalified product continues to comply with WHO prequalification requirements.

General application timelines

• Pre-submission: PQS will contact the manufacturer within one month after receiving a complete pre-submission form.
• Dossier review and decision: PQS will contact the manufacturer within one to two months of receiving the dossier, depending on the number of clarification questions raised by the dossier review team.

Manufacturers will find it useful to consult the relevant PQS standard operating procedures (SOPs).

Prequalification fees

WHO levies a non-refundable fee for dossier evaluation. Dossier evaluation fees are set per category of products or devices and range from US$ 2000 to US$ 3200, except for coolant packs, for which the application fee is US$ 600. The fee must be paid in full, in the specified currency, after the dossier has been assessed by PQS. WHO will invoice the applicant after the product has been prequalified.

Manufacturers of prequalified products are also charged a fee for the annual product review of each of their prequalified products. These are set per category of product and range from US$ 1200 to US$ 1600, with the exception of coolant packs, for which the annual review fee is US$ 300.