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Dossier Preparation

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:

  • Cover letter
    • Ensure that the “request” is clearly stated by referencing the proposed Service Code
  • 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.
  • 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.
  • 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
  • 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