Natural Health Products Online Solution Electronic Submission Builder User Manual

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

March 13, 2012 - Version 1.0

Table of Contents

List of Figures

List of Tables

1 Introduction

1.1 Overview

The NHP Online eSubmission Builder (eSB) is a software application that is available to be downloaded from the NHP Online website, and installed on a user's computer. It enables the user to create an electronic submission package that includes a completed electronic product licence application (ePLA) form and associated attachments which support the application and register a PLA for natural health products with Health Canada.

The eSB facilitates the creation of an electronic Submission Package (HCS file). The eSB allows users to describe required or optional attachments (e.g.: Cover Letter, Label information, etc.), and will automatically include information provided in the completed ePLA.  Users can then attach the described documents electronically to include them in the Submission Package.  The electronic portion of the Submission Package is then sent to the NHP Online System using either Canada Post secure email or Read Only storage media (see <reference> for accepted media types).  A Submission Package Tracking Number that is identical to the ePLA tracking number is provided once the submission is validated successfully.  This tracking number is used to reference the submission with the NHPD before a submission number is given to the application. 

This user guide will provide eSB users with the functional and technical guidelines needed to use the software application. Requests for assistance, including requests for technical assistance, should be directed to the NHP Online System via email at NHP_initiative_PSN@hc-sc.gc.ca

1.2 Quickstart to the eSubmission Builder (eSB)

The general process for using the eSB to submit submission packages to Natural Health Products Directorate (NHPD) is as follows. This process is provided in more detail in Section 4.0:

  1. Create a submission file: Load a finalized ePLA. Specify pertinent supporting documents based on the information within the ePLA. Describe each document as per the required fields within the attachment details section. The information that describes a document is considered the document's meta-data.
  2. Validate the submission file: Meta-data is validated to ensure that mandatory fields have been completed. Business logic validates that all required supporting documents are included.  The eSB highlights missing or incomplete information in the submission file.
  3. Finalize the submission file: The index and all the electronic document files it has described are automatically packaged into a NHP Online Regulatory Zip file "HCS file" (the submission package).  Users can then send the HCS file through the Canada Post secure email (PosteCS) or store to a user-defined medium (e.g., CD, DVD) and mail it to NHPD. 

NHP Submission Types: There are two types of submissions represented in an HCS submission package:

  1. Electronic submission - Details about a new document, and the document is attached as an e-file.
  2. Paper submission - Details about the new document, and the document will be submitted as a printed document.

2 System Requirements

2.1 MANDATORY Requirement:

The operating computer must have the Sun Java Virtual machine (JVM) 1.6 or later available for running.

The Java Virtual Machine can be downloaded from the  Java Website
Click on the download link on the java.com homepage.
Follow the installation instructions provided by Sun, or instructions provided by your IT administrator

Suggested Minimum Computing Requirements - The configuration listed below is the environment in which the NHP Online eSubmission Builder was developed and tested. Other systems may be compatible:

  • IBM compatible PC
  • 1.6 Gigahertz (GHz) or faster Processor (Pentium IV Processor or comparable)
  • 1 Gigabyte (GB) of main memory or more (1 GB of RAM)
  • Storage capacity of 10MB disk space per application submission (equivalent of 200 - 2000 single sided pages depending on electronic format and graphics content of supporting documentation)
  • Windows 2000 Professional with Service Pack 4, XP with Service Pack 2, Vista with Service Pack 1 or Windows 7
  • High-speed internet connection

2.2 Downloading the eSubmission Builder Application

The eSB can be downloaded from the NHP Online website. The application is saved in a zip file named "submissionbuilder.zip". Once downloaded, simply unzip the executable file into a local directory (on your desktop or a network location).  The unzipped executable file will be called SubmissionBuilder-1.0.0-Setup.exe

To download the eSB, go to the Natural Health Products Online Solution web page, and click on the link, "Download the latest version of the e-Submission Builder (eSB) program."

This action will prompt you to choose a location to save the eSB on your computer/network. Browse and choose a location and click on 'save' to download the zip file. The zip file is about 22MB in size and will take less than one minute to download on a high speed Internet connection. Once downloaded, extract the executable file from the submissionbuilder.zip to a preferred location on your computer to start using the eSB.  The executable file is called SubmissionBuilder-1.0.0-Setup.exe.

2.3 Installing the eSubmission Builder Application

To start the installation process simply double click on the SubmissionBuilder-1.0.0-Setup.exe file and follow the installation wizard instructions, as described below.

Figure 1 - Language Selection

Figure 1: Language Selection

This figure is a snapshot of choosing the eSubmission Builder Installation Language. It gives the user the option to select the language for the installation process. The top segment of the figure is labelled ‘Language Selection’ followed by the text ‘Please select the installation language’. The default language selected is “English”. The user can change the language by editing the dropdown menu located in the middle segment of the figure. On the top-right hand corner, there is a small ‘Close’ button. The lower segment of the figure has two buttons. Located at the lower-left, the user can select the ‘OK’ button to continue the eSubmission Builder installation. Located at the lower-right, the user can select the ‘Cancel’ button to exit the installation process.

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Step 1:
Select the language of choice for the installation process.Select the language and select the [OK] button to continue.

Figure 2 -Verification of eSB Installation

Figure 2: Verification of the eSubmission Builder Installation

This figure is a snapshot of verifying the eSubmission Builder Installation. The top segment of the Figure is labelled 'Install Submission Builder'. On the top-right hand corner, there is a small 'Close' button. The middle segment is labelled 'This will install Submission Builder on your computer. Continue?' This figure gives the user the option to verify that the eSubmission builder will be installed on the computer. The lower segment of the image has two buttons; the user can select the 'Yes' button to continue the installation or the 'No' button to exit the installation process.

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Step 2:
Select the [Yes] button to continue the installation of eSubmission Builder now.

Figure 3 - eSB Wizard

Figure 3: eSubmission Builder Wizard

This figure is a reference to the Installation Wizard for eSubmission Builder Application. The top segment of the Figure is labelled 'Submission Builder Setup' followed by the text 'Welcome To Installation Wizard for eSubmission Builder Application'. On the top-right hand corner, there is a small 'Close' button. The middle segment of the figure verifies the version of the eSubmission Builder application; it prompts the user to close all other applications before continuing the installation process. The lower segment of the image has two buttons; the user can select the 'Next' button to continue the installation, or the 'Cancel' button to exit the installation process.

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Step 3:
Select the [Next >] button to continue the setup of eSubmission Builder.

Figure 4 - Choosing Destination Folder

This figure gives the user the option to select the destination folder where the eSubmission application will be installed. The top segment of the image displays the text 'Where should the Submission Builder be installed?' followed by the text 'Setup will install Submission Builder in the following folder. To install to this folder click Next, to install to a different folder click Browse and select the folder'. On the top-right hand corner, there is a small 'Close' button. The lower segment of the image has the default destination folder as 'C:\Program Files\Submission Builder'. The user can change the destination folder by selecting the 'Browse' button. There are three buttons located at the bottom of the image; the user can select the 'Back' button to review changes, the 'Next' button to continue the installation, or the 'Cancel' button to exit the installation process.

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Step 4:
Select the [Next >] button to continue the setup of eSubmission Builder in a folder called C:\Program Files\SubmissionBuilder. If you wish to choose an alternative location for the eSubmission Builder, select [Browse] to choose the location.

Figure 5 - Copying Files

This figure verifies that setup has enough space to start copying the program files. The upper segment of the image, the text 'Start Copying Files' is displayed, followed by "Install Directory and Setup Type'. On the top-right hand corner, there is a small 'Close' button. There are three buttons located in the lower segment of the image; the user can select the 'Back' button to review changes, the 'Next' button to continue the installation, or the 'Cancel' button to exit the installation process.

Back

Step 5:
Select the [Next >] button to continue the setup of eSubmission Builder in the folder location that was chosen from Step 4.The installing of files will progress after the [Next >] button is selected.

Figure 6 - Installation Wizard Complete

This figure verifies that the installation wizard has successfully installed the eSubmission Builder Application. The top segment of the image, the text 'Install Wizard complete' is displayed, followed by the instruction to the user 'This wizard has successfully installed Submission Builder click Finish to exit the wizard'. On the top-right hand corner, there is a small 'Close' button. Located in the middle segment of the screen there are three check boxes. The first check box is checked and labelled 'Launch Submission builder'. The second check box is NOT checked but labelled 'Create a Start Menu Shortcut'. The third check box is checked and labelled 'Create the Desktop Shortcut'. The user has the option to check the corresponding check boxes to execute the given function. The lower segment of the image, the user can select the 'Finish' Button to complete the installation process.

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Step 6:
Select the [Finish] button to complete the setup of eSubmission Builder.

You can choose options of creating shortcut icons in the start menu and/or the Desktop.

When running the Windows 7 operating system, you need to make sure of the following to ensure you avoid any potential problems with installing eSub Builder:

1. The installing user should have Administrator privileges
2. The installing user installs the program into an alternate location.

Recommendation:

Use Windows Explorer to create a folder called "C:\My Programs"
Then specify "C:\My Programs\Submission Builder" as the location for the installation into SubmissionBuilder Setup.

3. In addition, following installation, you may see the Program Compatibility Assistant dialog appear.
From this dialog, you may select "This program installed correctly".

2.4 Un-Installing the eSubmission Builder Application

To start the Un-installation process, simply execute the following steps:

Figure 7 - Locating the C Drive

This figure is a snapshot of Locating the C: Drive in the explorer window. The file hierarchy of explorer file folders are displayed. The top segment of the image has the Menu bar with text captioned 'File, Edit, View, Favourite, Tools and Help'. The image then displays the Standard Button and Address tool bars. The right segment of the image has the C: Drive file folders. The left segment of the image has the following folders: 'Desktop, My Document, My Computer, (C :) Local Disk and the folders of the C Drive'.

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Step 1:
Close eSubmission Builder application, if it is open.

Step 2:
Open the Explorer program

Step 3:
Select the C: drive

Figure 8 - Selecting the Program Files Directory

This figure shows an example of selecting the program files directory that is located on the C: Drive. The left segment of the image is the 'Program Files' folder, this is highlighted. The right segment of the image has the Program Files sub folders.

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Step 4:
Select Program Files subfolder

Figure 9 - Selecting the Submission Builder Folder

This figure shows an example of selecting the eSubmission Builder Folder. The left segment of the image is the 'Submission Builder' folder, this is highlighted. The right segment of the image is blank.

Back

Step 5:
Locate and delete the entire subfolder SubmissionBuilder (including all its subfolders and files)

Figure 10 - Removal of eSubmission Builder

Figure 10: Removal of eSubmission Builder

This figure shows confirmation of the Removal of eSubmission Builder Application. In the top-left hand corner the text 'Confirm Folder Delete' is displayed. On the top-right hand corner, there is a small 'Close' button. The top segment of the image the following text is displayed 'Are you sure you want to remove the folder 'Submission Builder' and all its contents to the recycle bin'. The lower segment of the image has two buttons; the user can click on the 'Yes' button to remove the eSubmission builder or the 'No' button to exit.

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Step 6:
Select "Yes" button.

After few seconds the "Submission Builder" will be entirely uninstalled from your computer.

Figure 11 - Deleting the Shortcut

Figure 11: Deleting the Shortcut

This figure shows an example of selecting the delete option to remove the eSubmission Builder shortcut. The following text are displayed 'Cut', 'Copy', 'Create Shortcut', 'Delete', and 'Rename'.

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Figure 12 - Confirmation of Shortcut Removal

Figure 12: Confirmation of Shortcut Removal

This figure verifies the removal of the eSubmission Builder Shortcut. On the top-left hand corner, the text 'Confirm Shortcut Delete' is displayed. On the top-right hand corner, there is a small 'Close' button. The Middle segment of the image displays the following text 'Deleting the shortcut to submission builder only removes the icon. It does not uninstall the program. If you want to uninstall the program use the Add or Remove Programs in the control panel'. The lower segment of the image has two buttons; the user can the user can select the 'Delete Shortcut' button to remove the shortcut or the 'Cancel' button to exit the operation.

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Step 7:
If you had created an icon (Shortcut) for eSubmission Builder on your desktop, you may delete it by right clicking on it and selecting "Delete" option. Then it asks you for confirmation of deletion, where you may click on "Delete Shortcut" button.

3 eSubmission Builder Introduction

Once the installation is complete you can open the eSB by double clicking on the Submission Builder icon on your desktop.

Initially, the only active area of the eSB is a menu bar along with a matching set of command buttons. These command buttons will be activated and deactivated to reflect the options available to the user depending on the status of the open Submission Package. The graphic below shows the different functions of each of these command buttons. Each of these functions is also available through the menu bar and is explained in detail in Section 5.0.

Figure 13 - eSubmission Builder Command Menu Bar

Figure 13: eSubmission Builder Command Menu Bar

This figure displays the eSubmission builder Command Menu Bar. In the Middle segment of the image, the command keys listed are: 'File, Edit, View, Tools and Help'. In addition, the image also displays the following Graphical Menu Icons: 'Create New Submission Package, Open Submission Package, Save Submission Package, Close Submission Package, Add Attachment To Submission, Delete Attachment, Validate Submission Contents, and Validate Success Indicators'. These graphical Menu Icons are labelled pointing to the corresponding icons on the Image.

Back

Once an eSB file (i.e.: HCS file) is created or opened through the eSB, the application will expand to display additional information. The eSB will expand to 3 viewable frames: The Submission Details Frame, the Attachments Frame and the Attachment Details Frame.

Figure 14 - eSubmission Builder Frames

Figure 14: eSubmission Builder Frames

This Figure is a snapshot of the eSubmission Builder Frames. On the top-left hand corner the text 'NHP Online submission Builder - SB5.4.3-NTradGlucosamagic – 27Z2Q22.hsc' is displayed. On the top-right hand corner the 'Minimize', 'Maximize' and 'Close' buttons are located. The top segment of the image has the Menu Commands with text captioned 'File, Edit, View, Favourite, Tools and Help', followed by the Graphical Menu Icons. The top segment also has the 'Submission Details' frame, the middle segment has the "Attachments' frame and the lower segment has the 'Attachment Details' frame.

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The proportions of the three frames can be adjusted by clicking-and-dragging the frame separator bar between the two frames.

3.1 Submission Details Frame

The top frame of the fully expanded eSB is named the Submission Details Frame. This frame displays high-level information contained in the ePLA file.  This frame extracts basic information from the ePLA including: Primary brand name, Tracking number, Applicant/Company name, Company code, Application type and Dosage form.

This frame also allows user to select the type of media the submission and attachments will be submitted to NHPD including:

  • Electronic - the ePLA and ALL attachments will be submitted within the HCS file in electronic format
  • Paper - the PLA and ALL attachments will be submitted in paper format through mail.

3.2 Attachments Frame

The second frame of the fully expanded eSB is the Attachments Frame.  This frame displays a list of all attached documents within the package.  The Attachments frame gives information on the attachment type, and the attachment name specified by the user.  As the user completes the mandatory information within the Attachments Details Frame (described below), the 'flag' icon will turn 'green' to visibly show that all mandatory user input for that attachment has been completed.

3.3 Attachment Details Frame

The third frame of the fully expanded eSB is the Attachment Details Frame. This frame is used to input information (meta-data) about an attachment.

To enter information, select an attachment from the List of Attachments in the Attachments Frame and enter the details in the corresponding fields of the Attachment Detail Frame. To view document details in the Attachment Detail Frame, select the corresponding row in the List of Documents Frame and the information will be automatically populated in the matching fields.

More information about each of the fields in the Document Detail Frame is available in Section 6.0 "Field Definitions and Usage".

The Submission Details and Attachment Details frames can be controlled by clicking the View menu and selecting the appropriate frame. This will either Hide/Show each frame as selected. This function can assist with maximizing available screen space within the eSB application.

4 Building an Electronic Submission Package  (a Finalized HCS File)

Once you have opened the eSB, you can proceed to either create a new eSubmission package (HCS file) or open a previously saved HCS file for further editing. The following sections provide information on both the functionality of the eSB and data entry rules for creating an HCS file.

 4.1 Creating a new eSubmission Builder File (HCS file)

To create a new HCS file, click on the File/New menu item (or 'NEW'command button). This will open a dialogue box to select a "Finalized" electronic Product License Application (ePLA) file (.pdf format). A new HCS file must start by selecting a finalized ePLA document.  You cannot add an incomplete (e.g.: non-finalized) ePLA.  This will give an error message when attempting to add an incomplete ePLA.

4.2 Opening an Existing eSubmission Builder File (HCS file)

To open an existing HCS file, click on the File/Open menu item (or 'OPEN' command button). This will open a browse window where you can locate and select the desired HCS file and open it in the eSB. Valid eSB files that can be opened in the eSB have an HCS extension and must have been created using the eSB.

4.3 Adding Information to an eSubmission Builder File

The first step in adding information to an HCS file is to add an attachment to the submission file.  This is done by selecting Edit/Add from the menu [or selecting 'ADD' from the command bar].  

Users will then need to select the 'type' of attachment that will be added. This is accomplished by selecting an 'Attachment Type' in the dropdown list within the Attachment Details frame.  Depending on the type of attachment that the user plans to attach, different meta data will be displayed and required to be entered for the corresponding attachments.

Once the Meta data has been entered, users can continue to add attachments by selecting Edit/Add from the menu [or selecting 'ADD' from the command bar].

Detailed instructions on adding information to each of the meta-data fields of an HCS attachment are available in Section 6.0 "Meta-data Field Definitions and Usage".

4.4 Saving an eSubmission Builder file

You can save the HCS file you are working on at any time and it is advisable to do so often while you are working on the file. To save the current HCS file select the File/Save option from the menu [or click on the 'SAVE' button on the command bar]. If you are saving an HCS file for the first time, you will be prompted for a location to save the file. The name of the file will be automatically generated as "Primary Brand Name - Tracking NumberHCS". If you have previously saved the HCS file, clicking on the 'save' button will automatically save the new changes to that particular file. By default the file will be saved with an HCS extension.

4.5 Validating an eSubmission builder file

Once all the supporting information has been added to the HCS file, you can perform a check on the information by selecting the Tools/Validate Submission option from the menu [or click on the 'VALIDATE' button on the command bar]. You will be notified of any blank mandatory fields and blank non-mandatory fields. If you receive a notification about a missing mandatory field you must add data to that field to be able to finalize and submit the HCS file. Notification about non-mandatory fields is precautionary and an HCS file may be finalized when some non-mandatory fields are missing. However, it is strongly recommended that you include all available information about an attachment in the submission, even if the field is categorized as non-mandatory.

Figure 15 - Validation Failed Message Window

Figure 15: Validation Failed Message Window

This figure is in reference to the Validation Failed Message Window. On the top-left hand corner the text 'Validation Failed' is displayed. On the top-right hand corner, there is a small 'Close' button. The top segment of the image the text 'Submission' is displayed followed by 'Safety and / or Efficacy Reference'. The upper segment of the images displays the text 'Title'. The Middle segment of the image is blank. The lower segment of the image, there is a button with text 'OK'; the user can click this to continue.

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Based on the details the user has entered in the ePLA, eSB will validate that all the required attachments and supporting documentation have been included in the submission.

Also, each attachment within the Attachments Frame will have a 'red' or 'green' flag indicating that particular attachment has passed the meta data validations.  If any attachment has a 'red' flag, it indicates that particular attachment may require modifications within the Attachments Details frame. 

4.6 Submitting the eSubmission Builder Submission Package

Once all validations have been flagged 'green', the HCS file will be considered final.  A finalized HCS file can be submitted to the NHPD via the PosteCS secure email (requires enrolment) or on CD-ROM, DVD-ROM.

The CD-ROM/DVD-ROM media label must include the following:

  • Applicant/Registrant Name (Print)
  • Applicant/Registrant signature (indelible ink)
  • Product Primary Brand Name
  • Attestation Code from the ePLA
    • Code generated within ePLA in attestation block
  • Date of the submission package (HCS file)
Please ensure the HCS Submission Package has been finalized within eSubmission Builder before submitting to Health Canada. Should the HCS package not be finalized, then it will be rejected by Health Canada internal systems.
Please ensure that your ePLA tracking number is not a duplicate of a previously sent ePLA when sending a new HCS submission package. This will slow down your overall application processing time and may lead to a request to resubmit your applicant with a new tracking number.

5 Menu Commands and Command Buttons

All of the eSB commands are available from the command menu at the top of the application window. Some of the commands also have a button on the Command Button bar below the command menu. The following sections provide detailed descriptions of each of the functions available through the eSB and are followed by a table summarizing all the functions, shortcuts and associated command buttons.

5.1 File Menu

Figure 16 - File Menu Commands

Figure 16: File Menu Commands

This figure is in reference to the File Menu Commands. From top to bottom, the following File Menu commands are displayed: The 'New' button with the "Alt + N" command, the 'Open…" button with the "Alt + O" command, the 'Close' button, the 'Save' button with the "Alt + S" command, the 'Save In…' button, the 'Print…' button with the "Ctrl + P" command, the 'Import Electronic Form…' button with the "F8" command and the 'Exit' button with the "Alt + X" command. The print button is highlighted.

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Create a New eSB (HCS) File

File / New
Launches the "Select the electronic PDF Form" dialogue box and opens for users to select a completed ePLA. If an HCS file is currently open, you will be prompted to save the current file before a new HCS file is opened.

Open an Existing eSB (HCS) File

File / Open...
Launches a file browse dialogue box to open an existing HCS file. HCS files that can be opened through the eSB should have been previously created through the eSB. If an HCS file is currently open, you will be prompted to save before an existing file is opened.

Close an Open eSB (HCS) File

File / Close
Closes the current HCS file. You will be prompted to save the current file before the HCS file is closed.

Save an eSB (HCS) File

File / Save
Saves the currently open file with the current name and overwrites the file on disk without prompting. If the current file has not been previously saved, you will be prompted to select the save location and the name will default to "Primary Brand Name - Tracking NumberHCS" for the file to be saved. HCS files are saved as HCS files.

Save an eSB (HCS) File with a new name
File / Save In...
Saves the currently open file to a new location. The file name remains the same, but allows user to choose a different location.  If user chooses the same location as originally saved, then the user is prompted to confirm if he wishes to overwrite the original file. HCS files are saved as HCS files by default.

Print the eSB Meta data and Bar codes
File / Print...
Prints all the Meta data that has been inputted by the user.
Prints bar codes from the eSB that needs to accompany the ePLA bar codes if the user chooses to send in the submission on paper.

Import an updated ePLA form
File / Import Electronic form...
Allows users to update the ePLA within the HCS file.
If the user needed to modify the ePLA, this feature would allow the ability to import an updated and finalized ePLA to an existing HCS submission archive.

Exit the eSubmission Builder
File / Exit
Closes the eSubmission Builder. If there is an open file with unsaved changes, the application prompts to save before exit.

5.2 Edit Menu

Figure 17 - Edit Menu Commands

Figure 17: Edit Menu Commands

This figure is a snapshot of the Edit Menu Commands. The top segment of the image displays the 'Add' button with the "Alt + A" command and the lower segment of the image displays the 'Delete' button with "Alt + Delete" command.

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Add an Attachment to the List of Attachments Frame

Edit / Add
Adds an attachment to the List of Attachments Frame. Select the new row to begin adding information via the Attachments Details Frame about the particular attached document.

Remove an Attachment from the List of Attachments Frame

Edit / Delete
Deletes the selected row in the List of Attachments Frame. If the row being deleted has information in any field, the user will be prompted to confirm the delete command.  All previously entered information for that Attachment is lost.

5.3 View Menu

Figure 18 - View Menu Commands

Figure 18: View Menu Commands

This figure is a snapshot of the View Menu Commands. The top segment of the image displays a check mark followed by the text 'ToolBar'. The middle segment displays a check mark followed by the text 'Submission details'. The lower segment of the image displays a check mark followed by the text 'Attachment Details'.

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Hide or Show the Command Menu Bar
View / Hide-Show Command menu bar
Hides or shows the command menu bar.

Hide or Show the Submission Details Frame
View / Hide-Show Submission Details
Hides or shows the submission details frame.

Hide or Show the Attachment Details Frame
View / Hide-Show Attachment Details
Hides or shows the attachment details frame.

5.4 Tools Menu

Figure 19 - Tools Menu Commands

Figure 19: Tools Menu Commands

This figure is a snapshot of the Tools Menu Commands. The upper segment of the image displays 'Validation Errors…' button with the "F3" command and the lower segment of the image displays 'Preferences…' button with the "Alt + P" command.

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Validate a eSB (HCS) File

Tools / Validate Submission
Checks all mandatory fields, then all non-mandatory fields for values. If any mandatory fields are missing values, the Validation message gives details on where the submission failed validation.

The validation also ensures that all required attachment documents are attached based on details within the ePLA. The Validation message will give details on what attachments are missing.

Set Language Preference

Tools / Preferences... / Language/Langue
Sets the language of choice for the eSB application.  Changing the language preference has no effect on any of the user entered data in previously created HCS files.

5.5 Help Menu

Figure 20 - Help Menu Commands

Figure 20: Help Menu Commands

This figure is a snapshot of the Help Menu Commands. The upper segment of the image displays the 'Help…' button with the "F1" Command and the lower segment displays the 'About…' button with the "F5" command.

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Get Help with the eSubmission Builder

Help / Help...
Selecting the Help command will provide the website address to download this user guide, and any help desk contact information that is currently available through Health Canada.

About the eSubmission Builder

Help / About...
Shows the version information for the currently running version of the eSubmission Builder. This information may be required by NHPD staff to provide troubleshooting and support.

5.6 Quick Guide to eSubmission Builder Functions

Table 1 - Quick Guide to eSubmission Builder Functions
Function Menu Item Keyboard Shortcut Command Button
Create a New Submission Package (HCS file) File / New Alt + N
Open an Existing Submission Package (HCS file) File / Open Alt + O
Close an Open Submission Package (HCS file) File / Close    
Save a Submission Package (HCS file) File / Save Alt + S
Save a Submission Package (HCS file) with a new name File / Save In...    
Close the eSubmission Builder File / Exit Alt + X
Add an Attachment to the List of Attachments Frame Edit / Add Alt + A
Remove an Attachment from the List of Attachments Frame Edit / Delete Alt + Delete
Hide or Show the Command Menu Bar View / Hide-Show Command menu bar    
Hide or Show the Submission Details Frame View / Hide-Show Submission Details    
Hide or Show the Attachment Details Frame View / Hide-Show Attachment Details    
Validate a eSB (HCS) File Tools / Validate Submission F3
Set Language Preference Tools / Preferences... / Language/Langue Alt + P  
Get Help with the eSubmission Builder Help / Help... F1  
About the eSubmission Builder Help / About... F5  

6 Field Definitions and Usage

The eSubmission Builder contains information fields in each frame. The following is a list of all fields in an eSubmission Builder HCS file accompanied by a brief description of each field. The mandatory fields in the eSB are marked by an asterik

6.1 Fields Within The Submission Details Frame

Figure 21 - Submission Details Frame

Figure 21: Submission Details Frame

This figure is a snapshot of Submission Details Frame. The top segment of the figure is labelled 'Product Licence Application Submission'. The figure displays the following fields:
No. Six - Primary Brand Name,
No. Four - Applicant/Company Name,
No. One - Application Type,
No. Two - Tracking Number,
No. Three - Company code,
No. Five - Dosage Form.
No. Seven - Media. The Media Field has a drop down menu where the user can select the media type. The lower segment of the image is labelled from One to Eight with numbers corresponding to the fields above.

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  1. Application Type
    The Application Type field is a view only field for which the value is extracted from field 53 of the ePLA.  The field describes the type of application (e.g.: Compendial, Non-Traditional)
  2. Tracking Number
    The Tracking Number field is a view only field that is extracted from the ePLA. The tracking number is the unique identifier that is generated when an ePLA has been "Finalized".
  3. Company code
    The Company Code field is a view only field that is extracted from field 5 of the ePLA. The company code is the unique identifier that is given to trading partner companies or companies that have previously received a license or had a product review.
  4. Applicant/Company Name
    The Applicant/Company Name field is a view only field that is extracted from field 4 of the ePLA.
  5. Dosage Form
    The Dosage Form field is a view only field that is extracted from Part 4, Section D of the ePLA. The dosage form is based on the selected route of administration and populated by a dropdown list on the ePLA.
  6. Primary Brand Name
    The Primary Brand Name field is a view only field that is extracted from the ePLA.  The primary brand name is free-form text within the ePLA
  7. Media
    The Media field is a dropdown list that lets the user select [Electronic or Paper only].  This selection allows the user to indicate that the entire submission will be submitted to NHPD electronically or entirely in paper format.
  8. Type
    The Type field describes the type of form within the submission package.  This is currently set to 'New ePLA'.

6.2 Fields Within the Attachments Frame

Figure 22 - Attachments Frame

Figure 22: Attachment Frame

This figure is in reference to the Attachment Frame. The top segment of the image has a table labelled 'Type'. The table consists of two columns with four rows. The columns are labelled 'Type' and 'Title'.

The following are listed in the rows:

First row 'Label Information' the corresponding Title is 'Proposed Regulatory Label Text',
Second row 'Quality Information' the Title is 'Finished Product Specification',
Third row 'Pre- Cleared Information (PCI) Reference' the corresponding Title is 'Both Safety and Efficacy,
The final row 'Safety and/ Efficacy Reference' with Title 'Wonder drug'.

The lower segment has two boxes labelled 'Type' and 'Title' pointing to the two columns.

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  1. Type
    The Attachment Type field is a view only field that is populated when the User selects an attachment type from the Attachments Details Frame. The field describes the type of attachment that is being added to the submission file (e.g.: Correspondence & Cover Letters; Quality Information, Safety and /or Efficacy Information; Label Information; Other supporting information).
  2. Title
    The Title field is a view only field that is populated when the User selects a certain type of attachment.  It is a read only field that describes the attachment based on meta data within the Attachment Details Frame.

6.3 Fields within Attachments Details Frame

Figure 23 - Attachment Details - Correspondence & Cover Letters

Figure 23: Attachments Details - Correspondence and Cover Letter.

This figure is a snapshot of the Attachments Details - Correspondence and Cover Letter. The top segment of the figure from left to right displays 'Attachment Type' with a drop down box captioned 'Correspondence & Cover Letters'. This is followed by a label 'Correspondence Type' with a drop down menu box captioned 'Cover Letter'. The lower segment of this figure consists of the number One pointing to Attachment Type and the number two pointing to 'Corresponding Type'

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  1. Attachment Type - Correspondence & Cover Letters
    The Attachment Type field is a dropdown list that is populated when the User selects an attachment type.  The field describes the type of attachment that is being added to the submission file (e.g.: Correspondence & Cover Letters; Label Information, Quality Information, Pre-Cleared Information Reference; Safety and/or Efficacy Reference; Traditional Evidence Reference, Other supporting Information, Homeopathic Evidence Reference, etc.).

    When the Correspondence & Cover letters attachment type is selected, there is only one additional detail that must be selected called Correspondence Type

  2. Correspondence TypeThe correspondence type field is a dropdown list that is populated when the User selects a correspondence type.  The field describes the types of correspondence that is being added to the submission file (e.g.: Cover Letter, General Correspondence)

Figure 24 - Attachment Details - Label Information

Figure 24: Attachments Details - Label Information

This figure is in reference to Attachments Details - Label Information. The upper segment of this figure from left to right is labelled 'Attachment Type' with a drop down box captioned 'Label Information'. This is followed by the text 'Label Type' with a text field captioned 'Proposed Regulatory Label Text'. The lower segment of this figure consists of the number one pointing to 'Attachment Type' and number two pointing to 'Proposed Regulatory Label Text'

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  1. Attachment Type - Label Information
    When the Label Information attachment type is selected, there is only one additional detail that may be edited called Label Type.
  2. Label Type
    The label type field is an editable text field that is pre-populated with the following text: "Proposed Regulatory Label Text".  The user may edit this field to better describe additional information about the label that may be attached (e.g.: Box label, small label, etc.).

Figure 25 - Attachment Details - Quality Information

Figure 25: Attachments Details - Quality Information

This figure is a snapshot of the Attachments Details - Quality Information. The top segment of this figure from left to right, is labelled 'Attachment Type' followed by a drop down box with text captioned 'Quality Information'. This is followed by a label 'Information Type' and a drop down menu captioned 'Finished Product Specification'. In addition, the middle segment of the image on the left is the label 'Master File Reference No" followed by a blank text field. The lower segment of this figure consists of the number One pointing to 'Attachment Type', the number Two pointing to blank field and the number Three pointing to the drop down menu captioned 'Finished Product Specification'.

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  1. Attachment Type - Quality Information
    When the Quality Information attachment type is selected, there are two additional details that must be selected; Information Type and Master File Reference No.
  2. Master File Reference No.
    The Master file reference number is the reference ID for the Natural Health Product Master File (NHP-MF). This document provides information about the relevant manufacturing details including proprietary processes and/or the technical specifications of the medicinal and non-medicinal ingredients or raw materials that are used in the manufacturing of a natural health product (NHP).
  3. Information Type
    The Information Type field is a dropdown list that is populated when the User selects a Quality Information.  The field describes the types of quality information that is being added to the submission file (e.g.: Attestation, Certificate of Analysis, Drug Master File Access Letter, EDQM Certificate, Finished Product Specification, Manufacturing Information,  NHPD Master File Access Letter, Raw Material Specification, Other).

Figure 26 - Attachment Details - Pre-Cleared information (PCI) Reference

Figure 26: Attachments Details - Pre Cleared Information (PCI) Reference

This figure is in reference to Attachments Details - Pre Cleared Information (PCI) Reference. The top segment of this figure, from left to right, is labelled 'Attachment Type' followed by a drop down menu with text captioned 'Pre Cleared Information (PCI) Reference'. The upper-right hand side of the figure is labelled 'Supports' followed by a drop down menu with text captioned 'Safety Only'. The middle segment of the figure displays the following text 'PCI includes compendial monographs, abbreviated labelling standards, TPD Category IV Labelling Standards'. The middle segment of the image also has a label 'Description' followed by a blank text field. The lower segment of this figure consists of the number One pointing to 'Attachment Type', the number Three pointing to blank text field and the number Two pointing to the drop down menu captioned 'Safety Only'

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  1. Attachment Type - Pre-Cleared Information (PCI) Reference
    When the Pre-Cleared information (PCI) Reference attachment type is selected, there are two additional details that must be selected; Supports and Description.  The Pre-Cleared information (PCI) Reference attachment type does NOT require an attachment to be added to the submission file.  This attachment type does enforce the User to select Medicinal Ingredients within the ePLA that conforms to a pre-cleared monograph reference.
  2. Supports
    The Supports field is a dropdown list that is populated when the User selects a Pre-Cleared information (PCI) Reference type. This field describes what the PCI reference will support (e.g.: Safety Only, Efficacy Only, and Both Safety & Efficacy)
  3. Description
    The Description field is an editable text field. The user may edit this field to better describe the PCI monograph or claim reference for the specific Medicinal Ingredients selected.

Figure 27 - Attachment Details - Traditional Evidence Reference

Figure 27: Attachments Details - Traditional Evidence Reference

This figure is a snapshot of the Attachments Details - Traditional Evidence Reference.

The image consists of the following fields:

No. One - The label 'Attachment Type' with a dropdown menu captioned 'Traditional Evidence Reference',
No. Two - The label 'Title' with a text field captioned 'Reference to some Pharmacopeias',
No. Three - The label 'No. of Pages' with a blank text field,
No. Four - The label 'Authors' with a blank text field,
No. Five - The label 'Version / Date' with a blank text field,
No. Six - The label 'Supports' with a drop down menu captioned 'Both Safety and Efficacy',
No. Seven - The label 'Reference Type' with a drop down menu captioned 'Pharmacopoeia',
No. Eight - The label 'Recommended Use or purpose' with a text field captioned 'Relieves suffering from symptom of the common cold'.

The lower segment of this figure consists of the numbers One to Eight pointing to the corresponding fields labelled above.

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Figure 27: Attachments Details - Traditional Evidence Reference
  1. Attachment Type - Traditional Evidence Reference
    When the Traditional Evidence Reference attachment type is selected, there are seven details that must be filled out by the user; Title, No. of Pages, Author, Version / Date, Supports, Reference Type, Recommended Use or Purpose
  2. Title
    The title field will hold the complete title of the attachment being submitted. This title can be, for example, the title of a report or study being submitted, or when no formal title exists it can be a brief description of the document.
  3. No. of Pages
    The total number of pages that comprise the document to be attached. The field is not restricted to numeric characters. In the case of a range of pages of a document, indicate the range using dashes (e.g.: 5 - 25).
  4. Authors
    The names of the authors of the document in the attachment.  For multiple authors, the author names can be separated by commas.
  5. Version / Date
    The version or Date of the document to be attached.  The version is usually included in the formal documentation specification of reports, but may also be the version number used within the applicant's company. If no version exists, the User may input the creation date of the document if known.  This information is not used by NHPD to track the version of any one attachment.
  6. Supports
    The Supports field is a dropdown list that is populated when the User selects a Pre-Cleared information (PCI) Reference type. This field describes what the PCI reference will support (e.g.: Safety Only, Efficacy Only, and Both Safety & Efficacy)
  7. Reference Type
    The Reference Type field is a dropdown list that is describes the type of Traditional Evidence reference that is being attached (e.g.: Clinical Trial, Journal Article, Expert Opinion, Pharmacopoeia, Rationale, Text Book Reference, Website Reference, Other).
  8. Recommended Use or Purpose
    The Recommended Use or Purpose is an editable text field that the User may fill out to describe the claim or Use or Purpose statement within the ePLA that the attachment refers.

Figure 28 - Attachment Details - Safety and/or Efficacy Evidence Reference

Figure 28: Attachments Details - Safety and/or Efficacy Evidence Reference

The figure is a snapshot of the Attachments Details - Safety and/or Efficacy Evidence.

The image consists of the following fields:

No. One – The label 'Attachment Type' with a dropdown menu captioned 'Safety and/ or Efficacy Reference',
No. Two - The label 'Title' with a text field captioned 'Wonder Drug',
No. Three - The label 'No. of Pages' with a text field captioned '4',
No. Four - The label 'Authors' with a text field captioned 'Author1',
No. Five - The label 'Version / Date' with a text field captioned '1.0',
No. Six - The label 'Supports' with a drop down menu captioned 'Safety Only',
No. Seven - The label 'Reference Type' with a drop down menu captioned 'Clinical Trials'.

The lower segment of this figure consists of the numbers One to Eight pointing to the corresponding fields as labelled above.

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  1. Attachment Type - Safety and/or Efficacy Reference
    When the Safety and/or Efficacy Reference attachment type is selected, there are six details that must be filled out by the user; Title, No. of Pages, Author, Version / Date, Supports and Reference Type.
  2. Title
    The title field will hold the complete title of the attachment being submitted. This title can be, for example, the title of a report or study being submitted, or when no formal title exists it can be a brief description of the document.
  3. No. of Pages
    The total number of pages that comprise the document to be attached. The field is not restricted to numeric characters. In the case of a range of pages of a document, indicate the range using dashes (e.g.: 5 - 25).
  4. Authors
    The names of the authors of the document in the attachment.  For multiple authors, the author names can be separated by commas.
  5. Version / Date
    The version or Date of the document to be attached.  The version is usually included in the formal documentation specification of reports, but may also be the version number used within the applicant's company. If no version exists, the User may input the creation date of the document if known. This information is not used by NHPD to track the version of any one attachment.
  6. Supports
    The Supports field is a dropdown list that is populated when the User selects a Safety and/or Efficacy Reference type. This field describes what the Safety and/or Efficacy reference will support (e.g.: Safety Only, Efficacy Only, and Both Safety & Efficacy)
  7. Reference Type
    The Reference Type field is a dropdown list that is describes the type of Traditional Evidence reference that is being attached (e.g.: Clinical Trial, Journal Article, Expert Opinion, Pharmacopoeia, Rationale, Text Book Reference, Website Reference, Other).

Figure 29 - Attachment Details - Other Supporting Information

Figure 29: Attachments Details - Other Supporting Information

This figure is a snapshot of the Attachments Details - Other Supporting Information. The upper segment of this figure from left to right is labelled 'Attachment Type' with a drop down box captioned 'Other Supporting Information'. This is followed by a label 'Information Type' with a drop down box captioned 'Evidence Summary Report'. The lower segment of this figure consists of the number One pointing to 'Attachment Type' and numbers Two pointing to 'Evidence Summary Report'

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  1. Attachment Type - Other Supporting Information
    When the Other Supporting Information attachment type is selected, there is only one additional detail that must be selected called Information Type.
  2. Information Type
    The Information Type field is a dropdown list that is populated when the User selects other supporting information. This field describes the types of other supporting information that is being added to the submission file (e.g.: Evidence Summary Report, Assessment Template, Combination Rationale, Quality Summary Report, Safety Summary Report, Other).

Figure 30 - Attachment Details - Homeopathic Evidence Information

This figure is in reference to Attachments Details - Homeopathic Evidence Information.

The following fields are displayed:

  • No. One - The label 'Attachment Type' with a dropdown menu captioned 'Homeopathic Evidence Information',
  • No. Two - The label 'Evidence Information' with a text field captioned 'Claim Reference',
  • No. Three - The label 'No. of Pages' followed by a blank text field,
  • No. Four - The label 'Authors' followed by a blank text field,
  • No. Five - The label 'Version / Date' followed by a blank text field

The lower segment of the image consists of the numbers One to Five pointing to the corresponding fields as labelled above.

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  1. Attachment Type - Homeopathic Evidence Information
    When the Safety and/or Efficacy Reference attachment type is selected, there are six details that must be filled out by the user; Evidence information, No. of Pages, Author, Version / Date and Supports.
  2. Evidence Information
    The Evidence Information field is a dropdown list that describes the type of Homeopathic Evidence that is being attached (e.g.: Claim Reference and Pharmacopoeial Reference)
  3. No. of Pages
    The total number of pages that comprise the document to be attached. The field is not restricted to numeric characters. In the case of a range of pages of a document, indicate the range using dashes (e.g.: 5 - 25).
  4. Authors
    The names of the authors of the document in the attachment.  For multiple authors, the author names can be separated by commas.
  5. Version / Date
    The Version or Date of the document to be attached.  The version is usually included in the formal documentation specification of reports, but may also be the version number used within the applicant's company. If no version exists, the User may input the creation date of the document if known.  This information is not used by NHPD to track the version of any one attachment.

Figure 31 - Attachment Details - Related Ingredients

This figure is a snapshot of the Attachments Details - Related Ingredients frame. The upper right hand segment of the image is labelled 'Medical Ingredients(s) *' followed by an 'expansion button (+)'. The middle segment of the image consists of the label 'Medical Ingredients(s) followed by four check boxes. The first check box is checked and labelled 'Chicken's Gizzard-skin'. The second check box is NOT checked but labelled 'Garlic'. The third check box is checked and labelled 'Marconi wheat'. The fourth check box is checked and labelled 'Sodium chloride'. The middle segment of the image on the right hand side consists of a label 'Page Reference(s)' followed by a Blank Text Field. The lower segment of the image has the numbers One pointing to Medical Ingredients, the number Two pointing to the four check boxes, and the number Three pointing to 'Page Reference(s).

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  1. Medicinal Ingredients Selection
    For certain attachment types, the user must specify which medicinal ingredient within the ePLA is being referred.  The user can click on the [+] command button to show the selection list.
  2. Medicinal Ingredient
    If the attached document references a medicinal ingredient within Part 4 of the ePLA, then the user can select the appropriate ingredient. The selection will become highlighted when selected.
  3. Page Numbers
    The user must enter the page number(s) within the attached document that pertain to the reference evidence for the selected ingredient.

Figure 32 - Attachment Details - Document Upload

This figure is a snapshot of the Attachments Details - Document Upload.

The image consists of the following:

  • No. One - The text 'Media' followed by two radio buttons to the right. The first radio button is selected and it is labelled 'Electronic (file enclosed), the second radio button is not selected it is labelled 'Paper (document to be send separately).
  • No. Two - The text 'Original Document' followed by a text box captioned 'research_paper.doc' and a 'Browse' button.
  • No. Three - The text labelled 'Language' with a drop down menu captioned 'Chinese'.
  • No. Four - The text labelled 'Translate Document' followed by a blank text field and a 'Browse' Button.
  • No. Five - The text 'Language' followed by a dropdown menu captioned 'English'.

The lower segment of this figure consists of the numbers One to Five pointing to the corresponding fields as labelled above.

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  1. Media
    The user may select in the Submission Details frame if the submission will be electronic only or paper only. If the user selects paper only, the user must submit ALL the attached documents separately on paper.
  2. Original Document
    The full path and file name of the electronic file to be compiled into the HCS package when the HCS is finalized. This field is automatically populated when the electronic report is chosen through the browse button of the Original Document field. This information is stored in the local version of the HCS file only, and is NOT transmitted to NHPD.
  3. Language
    The language that the electronic file is written in. If the language is other than English or French, then the eSB will enforce the user to populate a translated document electronic file.
  4. Translated Document
    The English or French translated version of the original document
  5. Language
    The language that the translated document was written in. It must be either English or French.
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