Post-prequalification Procedures and Fees: Prequalified VCPs
Vector Control Products (VCP) submitted for prequalification assessment and that meet WHO prequalification requirements are included in the WHO List of prequalified VCPs. In order to maintain the prequalification status of a product the manufacturer must, within any applicable deadlines:
report changes relating to the product
fulfil prequalification commitments
open the manufacturing site(s) for routine re-inspection
ensure the ongoing compliance of the product with WHO specifications
The manufacturer of any VCP included in the WHO List of prequalified VCPs is required to report all changes related to the quality, safety or efficacy of the prequalified product – including, but not limited to, changes to its formulation, source ingredients, process/site(s) of manufacturing, specification(s) or labelling – to the WHO Prequalification Unit Vector Control Product Assessment Team (PQT/VCP).
The intent to change a prequalified VCP must be communicated to PQT/VCP before any change is made, to allow sufficient time for WHO to assess the change before its implementation. WHO will not approve any changes without assessment.
Additional information can be found here:
Change submissions should follow the established dossier preparation guidance for applications to WHO. Only those modules relevant to the proposed change should be submitted. Information on the dossier modules as well as all relevant forms can be found here:
Fulfilment of prequalification commitments
Commitments to prequalification must be fulfilled by the manufacturer within the agreed deadlines in order to keep the prequalification status of the product. Failure to meet prequalification commitments within the agreed deadlines will lead to delisting of the product(s) from the WHO List of Prequalified VCPs. Responses to prequalification commitments must be submitted as PPQC change applications as described above.
Routine re-inspection is carried out to ensure continued compliance with prequalification requirements. Routine re-inspections typically take place every three and up to five years after prequalification of a product, unless an earlier re-inspection is deemed necessary by WHO.
Ongoing compliance with WHO specifications
Manufacturers are expected to maintain compliance with the relevant WHO specifications for the VCP and source materials, as appropriate. Compliance with the established WHO specifications may be verified during inspection/re-inspection and/or post-market or quality assurance testing by a third party. Failure to comply with the relevant WHO specifications will require the manufacturer to take corrective actions to ensure compliance or submit the necessary application/information to establish new/revised specifications. Such noncompliance may lead to suspension of the prequalification until the product is brought into compliance or delisting of the product(s) from the list of prequalified VCPs.
Fees for prequalification
Currently, there are NO FEES associated with the prequalification of vector control products (VCPs) nor the assessment for the development of specifications. This includes post-prequalification submissions and activities.
Fee for service models are under consideration, but no determination has been made at this time. Any decisions about implementing a fee based model will be made with stakeholder consultation.