All prequalified products must undergo a formal annual review, to verify that they continue to meet prequalification, performance, quality and safety requirements.

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

The IMD-PQS Secretariat informs manufacturers 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.

Annual Review submission package

The 2024 Annual Review submission package is available for view here:

For prequalified product MANUFACTURERS:

• General introduction
• Manufacturer declaration
• Form A - Manufacturer
• Form B - Manufacturer/Reseller

For LICENCED RESELLERS of prequalified products:

• General introduction
• Reseller declaration
• Form A - Reseller
• Form B - Manufacturer/Reseller

For annual review submissions, current Prequalification Holders should ensure to refer to the latest 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 Dr. Isaac Gobina (gobinai@who.int) and Mr. Paul Mallins (mallinsp@who.int), copying pqsinfo@who.int.

If the re-evaluation is completed successfully the product is prequalified for a further 12 months.

IMD-PQS annual review fees administration

WHO will invoice the annual product review fees to the applicant or manufacturer by 31 March for each prequalified immunization-related product or device that was on the prequalification catalogue (list) up to the 31 December of the previous year. Payment should be made within 30 days of receipt of the invoice from WHO. The annual product review will not commence unless payment of the invoiced annual fees has been confirmed.