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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:
- 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.