Dossier Preparation
A modular approach
The VCP Dossier Requirements follow a modular approach which is:
- informed by eCTD and OECD standard dossier formats;
- easier to submit electronically;
- more efficient to screen for completeness;
- easier to provide the data to the appropriate experts; and
- contributing to collaboration and standardization.
NOTE: The modular approach is not a new requirement, it is simply the format in which the requirement information is communicated to WHO.
All information must be submitted in English.
It comprises six modules:
Module 1: Administrative information and labelling
- Cover letter
- Ensure that the “request” is clearly stated by referencing the proposed Service Code
- Application form
- Ensure the application form is complete and signed
- PQT/VCP Product Application Form
- PQT/VCP Post-PQ Change Application Form
- Table of Contents
- Ensure that the file names in the dossier match the titles provided in the Table of Contents
- If additional information is provided or documents revised, an updated ToC should be provided for the particular action
- PQT/VCP Dossier Table of Contents
- Declaration of Labelling (DOL)
- The DOL is the responsibility of the applicant. It is intended to provide information to support the assessment of the product quality, safety and efficacy, for those uses relevant to WHO. The DOL may not be a comprehensive product label. The product may be authorized for additional or different uses by National Regulatory Authorities (NRA). The product label authorized by an NRA may therefore differ from the DOL based on the country or regional labelling requirements.
- The DOL submitted in association with the product will be published as part of the prequalification listing.
Module 2: Discipline summaries
- Data and manufacturer conclusions are summarized in three documents:
- Summary of Quality Dossier
- Summary of Safety Dossier
- Summary of Efficacy Dossier
- This is the applicant’s opportunity to provide a summary of the supporting information provided for each discipline and communicate the applicant’s interpretation of the supporting information.
Module 3: Quality
- Physical/Chemical Data
- Ensure all supporting data is submitted
- Ensure studies are finalized and include signatures, including for attestation of GLP compliance
- The JMPS Manual is a guide for physical/chemical data requirements based on the formulation type of the product
- Proposed draft specification
- Declaration of Product Formulation
- The complete formula must be provided
- Sources of AIs must match those identified on the declaration of manufacturing sites or LOAs provided to verify intermediary distributors
- All sources of AI (and synergists) must be supported by a current evaluation report confirming compliance with the established specifications
- WHO PQT-VC Declaration of Product Formulation
- Description of Manufacturing Process
- This is not a standardized form
- Include a detailed description of the complete production process
- Declaration of Manufacturing Sites
- All relevant sites must be identified
- The information provided on this form will be used to publish the manufacturing sites for the product (upon prequalification)
- WHO PQT/VCP Declaration of Manufacturing Sites
Module 4: Safety
Module 4: Safety
- Active ingredient Specific Hazard Assessment(s) (or summary of publicly available information)
- Product Risk Assessment (Occupational and Residential Exposure)
- Generic risk assessment model for insecticides used for larviciding and mollusciciding
- Generic risk assessment model for indoor and outdoor space spraying of insecticides -- Second Edition
- Generic risk assessment model for indoor residual spraying of insecticides -- Second Edition
- Generic risk assessment models for insecticide-treated clothing, skin-applied repellents and household insecticides
- Generic risk assessment model for insecticide-treated nets – Second edition
- Acute toxicology (6-pack)
- Acute Inhalation
- Acute Oral
- Acute Dermal
- Primary Eye Irritation
- Primary Skin Irritation
- Dermal Sensitization
Module 5: Efficacy
- Supporting lab, semi-field and field studies
- Current data requirements are specified in the WHO Testing Guidelines
- Guidelines for laboratory and field testing of long-lasting insecticidal nets
- Guidelines for efficacy testing of spatial repellents
- Guidelines for testing the efficacy of insecticide products used in aircraft
- Guidelines for testing mosquito adulticides for indoor residual spraying and treatment of mosquito nets
- Guidelines for laboratory and field testing of mosquito larvicides
- Guidelines for efficacy testing of insecticides for indoor and outdoor ground-applied space spray applications
- Guidelines for efficacy testing of mosquito repellents for human skin
- For products claiming equivalence to an existing prequalified product, please review the following information to understand the data requirements per product type:
Module 6: Inspections
- Site Master File(s) must be submitted for all manufacturing facilities where all, or part, of the manufacturing of the product may take place.
- Manufacturing facilities must be certified and in good standing according to ISO 9001 or equivalent