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Prequalification application procedure

Prequalification application procedure

Prequalification application procedure

An application dossier must include:

  • complete details of the manufacturing process
  • documented evidence that the product meets the performance and functional requirements detailed in the relevant performance specification
  • complete manufacturing certification and licencing

Submission of a product dossier

If the WHO IMD-PQS Secretariat deems the product or device eligible for prequalification evaluation, it will invite the manufacturer or reseller to submit a full prequalification application, via the WHO e-prequalification (ePQS) platform.

The IMD-PQS Secretariat will send the applicant an application information pack which contains:

A signed copy of the WHO IMD-PQS Terms & Conditions must be included in each product prequalification application dossier.

Application Review Template

The IMD-PQS Application Review Template is a Microsoft Excel (.xls) document intended to collect and record and track information about the dossier completion status and the communication exchanges between the applicant and the IMD-PQS Secretariat that will take place throughout the dossier review process.

The Application Review Templates for each sub-category of product are available on the page: "Application Dossier Requirements".

The IMD-PQS Secretariat will provide the relevant category-specific Application Review Template to applicants via the WHO ePQS platform if, following pre-submission, the Secretariat deems the product or device eligible for prequalification evaluation.

Application requirements (list of application documents)

A generic list of requirements for the application dossier contents is provided on the page: "Application Dossier Requirements".

Important information for prospective applicants:

  • One dossier must be submitted for EACH product.
  • If the product is manufactured at more than one manufacturing site, one dossier must be submitted for EACH manufacturing site.
  • All documents submitted as a part of the application must adhere to file name conventions as described in Annex 3 of the WHO IMD-PQS Guidelines for Prequalification Holders, and in the prequalification information pack.

IMD-PQS prequalification fees administration

The dossier evaluation fees must be paid in full once the dossier has been accepted for evaluation. Payment should be made within 30 days of receipt of the invoice from WHO. The commencement of dossier evaluation will be triggered by a confirmation of payment of the invoiced fees.

Laboratory testing

Laboratory testing is required for the majority of products submitted for IMD-PQS prequalification. The type of laboratory testing required for each product is defined in the relevant Verification Protocol(s), and is defined by the Secretariat based on the volumes that will be deployed and whether the product is safety-critical.

Laboratory testing results must be submitted to the IMD-PQS Secretariat using the IMD-PQS Laboratory Test Report Template.

The three types of testing are:  

  1. Type-examination: An inspection of a production-run product. Required for items that are not programme-critical. 
  2. Independent type-testing: An inspection and a rigorous test of production-run product. Required for programme-critical products.
  3. Full quality assurance: An inspection of the production site carried out against a pre-defined checklist. Required for complex programme-critical products involving site-specific design and on-site installation work.

All independent type-testing must be carried out by an accredited testing laboratory. Type-examination or full quality assurance can be carried out either by an accredited laboratory or by an independent specialist appointed by IMD-PQS.

A list of accredited laboratories is provided on the page "Accredited laboratories".

Field testing

In some cases, the results of additional testing of a product or device in its intended operating environment may be required, for inclusion in the application dossier. WHO is responsible for identifying product types for which field-testing is either mandatory or desirable and will specify the appropriate generic testing method for each product type.

Field-testing will always be required for:

  • products that require the establishment of a new IMD-PQS category, and for
  • products that are based on technologies that are new to the Expanded Programme on Immunization.

Complete information about field-testing for applicants is provided on the page: "Product testing support for manufacturers".

Field-testing also provides product manufacturers with information to improve product design, and can further help end-users to select products tat are best suited to their needs and operating environments.

Method to submit the prequalification application dossier

Applicants must submit the application dossier exclusively via the WHO ePQS platform. Submissions by email or by postal mail are not longer accepted as of 2024.

Applications may be created on the ePQS platform at any time, once the applicant has received an invitation and information pack from the IMD-PQS Secretariat.

Dossier screening and evaluation

Each product dossier is screened for completeness before being evaluated, to make sure that all the required information and documentation have been submitted. If the dossier is incomplete, the applicant will be contacted via the WHO ePQS platform, and given a single opportunity to provide the missing information or material. If, after a reasonable period has elapsed, the applicant fails to supply the missing information or production-run product, the dossier will be rejected.

The dossier submission and evaluation process can be straightforward provided the dossier is complete, prepared as per the latest product specifications and all licences are up to date. If field evaluation and/or other validation of a product are required, results and/or laboratory tests outcomes must be included in the dossier.

Once a product dossier has been accepted it will undergo review by a group of technical specialists. This group is convened twice a month to review application dossiers and laboratory test results, as well as share its recommendations as to whether products meet the relevant IMD-PQS equipment performance specifications. The IMD-PQS Secretariat and technical specialists treat all information pertaining to a dossier evaluation with the strictest confidence.

Following dossier evaluation, the IMD-PQS Secretariat will inform applicants whether any clarifications or additional information is required before a final decision regarding prequalification can be taken.

Note: All applications relating to single-use injection devices will be processed strictly in accordance with the procedure described in WHO/BCT/03.09: Procedure for assessing the acceptability, in principle, of single-use injection devices for procurement by United Nations agencies.

Dossier evaluation timelines

The IMD-PQS Secretariat will render a decision to the applicant based on a complete application dossier submitted via the WHO ePQS platform within 60 days of receipt for all categories of products expect for category E001 Cold rooms and freezer rooms, for which a decision will be rendered within 90 days.

Prequalification

Once a product has been approved for prequalification, IMD-PQS will inform the applicant of this decision via the WHO ePQS platform. Details of the approved product are then "published" on this website and in the WHO IMD-PQS Catalogue of Prequalified Products.

Post-prequalification

Following prequalification, a product must meet a number of post-prequalification committments and obligations in order to maintain prequalified status. Failure to do so could result in withdrawl of prequalification status.