Annual Review
All prequalified products must undergo a formal annual review, to verify that they continue to meet the performance, quality and safety requirements of WHO immunization devices prequalification.
The annual re-evaluation exercise takes place each year in April and covers all products in the database of prequalified immunization devices, irrespective of the original date of prequalification. This means that in the first year following prequalification, a product may be re-evaluated less than 12 months after it has been prequalified.
The purpose of the annual review is threefold:
- to verify that certificates are up-to-date
- to check whether the product design or manufacturing process has changed
- to check whether any significant defects or failures have been noted.
Annual review requirements & proof of payment
The IMD-PQS Secretariat informs Prequalification Holders by email of the complete list of documents to be submitted for annual review. The Secretariat will indicate a deadline for receipt of the documents and to whom the documents must be sent.
Required documents and information includes:
- Company licences
- All relevant ISO certifications
- Notarised translations of licences and certificates that are not in English or French
- Copy of the relevant IMD-PQS product data sheets, including any required changes in annotation
- Information on product failures and complaints as well as the corrective and preventative actions (CAPAs) put in place to address them.
IMD-PQS annual review fees administration
As of 2025, payment of fees must be completed prior to the review of products in April. Prequalification (PQ) holders are contacted in January and requested to submit the list of products they wish to submit for re-evaluation, and those that conversely they wish to withdraw (if any). The IMD-PQS Secretariat then provides each PQ-holder with the necessary invoices. Payment should be made within 30 days of receipt of the invoice from WHO, and before the deadline for the submission of annual review documents, which takes places approximately one month after invoices are sent out. The submission package must include an official Proof of Payment for each invoice.
Important - products can not be re-evaluated until the invoice has been paid and proof of payment has been provided. Products for which the invoice has not been paid by the submission deadline will be automatically removed from the list of WHO-prequalified immunization devices.
 | Dossier evaluation fees | Annual fees | |
| E001 | Cold rooms, freezer rooms | 2400 | 1400 |
| E002 | Refrigerated vehicles | 2400 | 1400 |
| E003 | Refrigerators/freezers | 2400 | 1300 |
| E004 | Cold boxes/vaccine carriers | 2000 | 1200 |
| E005 | Coolant-packs | 600 | 300 |
| E006 | Temperature monitoring devices | 2400 | 1200 |
| E007 | Cold chain accessories | 2400 | 1200 |
| E008 | Injection devices for immunization | 3000 | 1600 |
| E010 | Waste management, safety boxes | 2400 | 1200 |
| E013 | Injection devices for therapeutic use | 3200 | 1600 |
Annual Review submission package
The 2025 Annual Review submission package is available for download here.
For Prequalification Holders that are product MANUFACTURERS:
For Prequalification Holders that are LICENCED RESELLERS of products:
Prequalification Holders should refer to the detailed submission package provided by email by the IMD-PQS Secretariat in February of each year.
Manufacturers of prequalified products must submit the required elements by email to Isaac Gobina (gobinai@who.int) and Paul Mallins (mallinsp@who.int), Albertus Knopper (knoppera@who.int) and Lauren Goodwin (lgoodwin@who.int)
If the re-evaluation is completed successfully, the product will be prequalified for a further 12 months.