Conversion of WHOPES recommendations to Prequalification
Products with WHOPES recommendations (interim and full) are eligible for inclusion on the List of Prequalified Vector Control Products
The following information is a supplement to the Overview of Prequalification of Vector Control Products Assessment document (see link below) which establishes the procedures to be followed by PQT-VC
PQT-VC is relying on existing product records, WHOPES Working Group Reports, JMPS Specifications and manufacturer input to identify products which have WHOPES recommendations.
Manufacturers who produce vector control products which have WHOPES recommendations are required to submit a Conversion Package to PQT for each product they wish to be considered for conversion. Manufacturers should inform PQT-VC by email of products which have a WHOPES recommendation for which they do not intend to maintain support.
Manufacturers who produce active ingredients for the purpose of inclusion within an end use vector control product are not required to submit a conversion package. Existing WHO specifications which include a manufacturer specific evaluation report are currently sufficient for identification of active ingredient manufacturers who meet the established standards for quality and safety.
Conversion Packages must be submitted by 31 December 2017. Manufacturers are encouraged to submit a Conversion Package as soon as it is available.
- Information be included in the Conversion Package:
- Application Form for Conversion to be filled for each product (Please see the link below)
- Application Form Instructions (Guidance in development)
- Current Product Labelling (in .pdf format) - Information on Labelling (Guidance in development)
- Product formulation(s) – Product Formulation Declaration Instructions (Guidance in development)
- Detailed description of the manufacturing process, highlighting any changes which may have been implemented since the original submission
- Site Master Files (SMFs) for all manufacturing sites
- SMF Guidance (please see the link below)
- PQT-VC is aware that the collation of this information may require additional time beyond due date for submission of requests for conversion. If SMFs are not available but in development, please submit your Conversion Package and indicate the expected date of completion/submission of the required SMFs.
- UPDATED INSTRUCTIONS
- Currently a Site Master File (SMF) for manufacturing sites which produce source active ingredients for use in the formulation of vector control products is not required. The SMF(s) for the end use product manufacturing sites should identify all the critical suppliers and all applicable quality agreements and management plans which are in place to ensure the quality of the source material.
- If multiple facilities are covered by the same ISO 9001 audit report, one SMF can be submitted with the required information on each of the sites.
- The ISO 9001 certification of a manufacturer can be extended to contract manufacturing sites. Documentation of quality agreements should be included with the supporting SMF.
- All information should be submitted in English.
- Instructions for Submission of a Conversion Package:
- Conversion Packages should be submitted to PQT-VC in a manner which protects any confidential business information included.
- Methods of submission may include:
- Encrypted or password protected email
- Password protected CD or DVD sent via mail (Please include a hard copy cover letter with the submission which identifies the manufacturer, point of contact, and product(s))
- Email: firstname.lastname@example.org
- Mailing address:
The WHO Prequalification Team - Vector Control
Regulation of Medicines and other Health Technologies
HIS/EMP/RHT/PQT - Vector Control
World Health Organisation
20 Avenue Appia
1211, Geneva 27
- Upon receipt of a Conversion Package, PQT will:
- Assign a PQT-VC Product Reference Number
- Ensure complete Conversion Package has been submitted
- Send Letter of Agreement for applicant signature
- Include the product on the list of Prequalified Vector Control Products, dependent on the following:
- Receipt of signed letter of agreement
- Confirmation of WHOPES recommendation through supporting WHOPES Working Group Reports and JMPS Specifications
Maintenance of the validity of prequalification decisions for those products whose WHOPES recommendation was converted:
- Within 5 years, PQT-VC will complete for each product:
- Manufacturing site inspections
- Desk review of the manufacturing process and SMFs
- Prioritization of product and associated facilities
- Finished product sampling in association with post marketing surveillance activities
- Review of available information:
- Label; formulation details; study reports; incident reporting; failure reports; other adverse effect information; safety profile
- Results of review may determine further investigation and the request for additional information
- Listing Decision
- If any deficiencies are identified as part of the inspections, finished product sampling, or review, the manufacturer will be informed and a timeline will be established for the rectification of issues.
- Based on the results of the inspections, finished product sampling, review, and rectification of issues, a decision will be made to maintain the listing, suspend the listing, or delist the product.
- Criteria for prioritization of the product conversion review schedule, including the following:
- Original recommendation date
- Available national regulatory authority inspection reports
- Product Concerns: Failure/Incident reports
- Any known changes/variations that may have been made, including transfer of ownership