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Drugs and Health Products

Description of the Figure 4: Leading Sheet

Figure 4 - displays a sample folder structure requirement for Level III Changes Form. It shows that a folder name using a letter followed by a letter then 6 or 7 numbers should be used as the “Dossier Identifier”.

  • Followed by, subfolder:
    • m1
  • Sub-subfolders:
    • 1.3 Product Information
    • 1.3.1 Product Monograph
  • Documents:
    • Product Monograph
    • Annotated Product Monograph
    • Annotated Product Monograph
    • Non-Annotated Product Monograph

Leading Sheets are an unacceptable way to introduce the documents provided in a section.

Note: * A letter followed by 6 or 7 digit depending on the regulatory activity type.