Why participate?

Manufacturers and licensed resellers of prequalified products contribute to WHO's goal of ensuring the availability of quality-assured, reliable products that help safeguard vaccine potency, as well as expand and extend their availability. Manufacturers and licensed resellers of prequalified products contribute to this goal by:

• manufacturing products in accordance with IMD-PQS performance specifications
• sharing feedback on equipment performance issues and taking appropriate corrective action
• informing WHO of emerging technologies that may be suitable for challenging operating environments.

At the same time, WHO prequalification offers manufacturers a number of benefits linked to:

• access to new markets

  • opportunities to supply products and devices for UN, and national procurement agencies that require prequalification
  • potential to become market-leaders in technologies for challenging operating environments

• product innovation

  • receipt of feedback on product performance and potential areas for improvement
  • access to WHO target product profiles, including information on evolving needs of local operating environments
  • opportunities to input to the process of product specification development

• brand recognition

  • status associated with producing quality-assured products
  • enhanced image through association with UN and national procurement agencies.

Which manufacturers can participate?

Any manufacturer of an immunization-related product or device 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 regarding the marketing, distribution, warranty arrangements and product maintenance either globally, or within a large geographical area.

Products offered by a manufacturer or licensed reseller must comply with one of the IMD-PQS performance specifications and its associated verification protocol(s). Products and devices are eligible for prequalification once they have been formally submitted to WHO and have passed the requisite verification process. Prequalified products will be added to the WHO IMD-PQS Catalogue of prequalified products and will be available for procurement by national immunization programmes of the WHO Expanded Programme on Immunization via UNICEF Supply Division, PAHO or other procurement agencies.

IMD-PQS will only prequalify one version of a product or device sourced directly from the legal manufacturer or licensed reseller. Re-badged or re-packaged variants will not be considered.

Information for manufacturers who wish to participate

The key sections of this website for manufacturers who wish to participate in WHO prequalification of immunization devices, and those already participating are:

• Benefits of WHO immunization devices prequalification ― what WHO immunization devices prequalification brings to its different stakeholders
• Catalogue of IMD-PQS prequalifed products ― extensive information on the different categories of products that WHO prequalifies, on those products that are prequalified, as well as category documentation, prequalification guidance for manufacturers and suppliers, and supporting information for users
• Prequalification procedures and fees ― what a manufacturer must do in order to obtain product prequalification
• IMD-PQS performance specifications ― access to all IMD-PQS performance specifications
• IMD-PQS verification protocols ― access to all IMD-PQS verification protocols
• Product testing support ― guidance to support the testing of products when required as part of the dossier submitted for evaluation
• Post-prequalification procedures and fees ― information on what an applicant must do to maintain prequalification status
• Post-marketing monitoring ― collection of information and operational feedback about product performance in immunization operating environments
• Guidance documents ― the principle types of guidance documents for manufacturers seeking prequalification of an immunization device
• Market information ― information about the markets for quality-assured immunization devices
• Product innovation ―  IMD-PQS activities to improve the quality and reliability of immunization products together with stakeholders
• Key contacts ― the key persons who can be contacted regarding different aspects of prequalification of immunization devices.