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Natural Health Products Online Solution: Electronic Submission

Builder User Manual

Health Canada

NHP Online eSubmission Builder User-Guide v1.0

Version 1.0 Page ii

Version Dated: Tuesday, March 13, 2012

Table of Contents

1 Introduction........................................................................................................................... 4

1.1 Overview ............................................................................................................................ 4

1.2 Quickstart to the eSubmission Builder (eSB) ..................................................................... 4

2 System Requirements ........................................................................................................... 6

2.1 MANDATORY Requirement ............................................................................................ 6

2.2 Downloading the eSubmission Builder Application .......................................................... 6

2.3 Installing the eSubmission Builder Application ................................................................. 7

2.4 Un-Installing the eSubmission Builder Application ......................................................... 10

3 eSubmission Builder Introduction .................................................................................... 13

3.1 Submission Details Frame ................................................................................................ 15

3.2 Attachments Frame ........................................................................................................... 15

3.3 Attachment Details Frame ................................................................................................ 15

4 Building an Electronic Submission Package (a Finalized HCS File) ............................ 16

4.1 Creating a new eSubmission Builder File (HCS File) ...................................................... 16

4.2 Opening an Existing eSubmission Builder File (HCS File) ............................................. 16

4.3 Adding Information to an eSubmission Builder File........................................................ 16

4.4 Saving an eSubmission Builder File................................................................................. 16

4.5 Validating an eSubmission Builder File ........................................................................... 17

4.6 Submitting the eSubmission Builder Submission Package .............................................. 17

5 Menu Commands and Command Buttons ....................................................................... 18

5.1 File Menu ......................................................................................................................... 18

5.2 Edit Menu ......................................................................................................................... 20

5.3 View Menu ....................................................................................................................... 20

5.4 Tools Menu ...................................................................................................................... 21

5.5 Help Menu ........................................................................................................................ 21

5.6 Quick Guide to eSubmission Builder Functions .............................................................. 22

6 Field Definitions and Usage ............................................................................................... 23

6.1 Fields within the Submission Details Frame .................................................................... 23

6.2 Fields within the Attachments Frame ............................................................................... 24

6.3 Fields within Attachments Details Frame ........................................................................ 24

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List of Figures

Figure 1 - Language Selection ........................................................................................................................ 7 Figure 2 -Verification of eSB Installation ...................................................................................................... 7 Figure 3 - eSB Wizard .................................................................................................................................... 8 Figure 4 - Choosing Destination Folder ......................................................................................................... 8 Figure 5 - Copying Files ................................................................................................................................. 9 Figure 6 - Installation Wizard Complete ........................................................................................................ 9 Figure 7 - Locating the C Drive .....................................................................................................................10 Figure 8 - Selecting the Program Files Directory ..........................................................................................11 Figure 9 - Selecting the Submission Builder Folder ......................................................................................11 Figure 10 - Removal of eSubmission Builder ...............................................................................................11 Figure 11 - Deleting the Shortcut ..................................................................................................................12 Figure 12 - Confirmation of Shortcut Removal .............................................................................................12 Figure 13 - eSubmission Builder Command Menu Bar.................................................................................13 Figure 14 - eSubmission Builder Frames ......................................................................................................14 Figure 15 - Validation Failed Message Window ...........................................................................................17 Figure 16 - File Menu Commands .................................................................................................................18 Figure 17 - Edit Menu Commands ................................................................................................................20 Figure 18 - View Menu Commands ..............................................................................................................20 Figure 19 - Tools Menu Commands ..............................................................................................................21 Figure 20 - Help Menu Commands ...............................................................................................................21 Figure 21 - Submission Details Frame ..........................................................................................................23 Figure 22 - Attachments Frame .....................................................................................................................24 Figure 23 - Attachment Details – Correspondence & Cover Letters .............................................................24 Figure 24 - Attachment Details - Label Information .....................................................................................25 Figure 25 - Attachment Details – Quality Information ..................................................................................26 Figure 26 - Attachment Details – Pre-Cleared information (PCI) Reference ................................................26 Figure 27 - Attachment Details – Traditional Evidence Reference ...............................................................27 Figure 28 - Attachment Details – Safety and/or Efficacy Evidence Reference .............................................28 Figure 29 - Attachment Details – Other Supporting Information ..................................................................29 Figure 30 - Attachment Details – Homeopathic Evidence Information ........................................................29 Figure 31 - Attachment Details – Related Ingredients...................................................................................30 Figure 32 - Attachment Details – Document Upload ....................................................................................31

List of Tables

Table 1 - Quick Guide to eSubmission Builder Functions ............................................................................22

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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 [email protected]

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.

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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.

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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.”

http://www.java.com/

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/index-eng.php

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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

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

Step 2:

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

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Figure 3 - eSB Wizard

Step 3:

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

Figure 4 - Choosing Destination Folder

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.

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Figure 5 - Copying Files

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

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.

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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

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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

Step 4: Select Program Files subfolder

Figure 9 - Selecting the Submission Builder Folder

Step 5:

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

Figure 10 - Removal of eSubmission Builder

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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 12 - Confirmation of Shortcut Removal

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.

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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

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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

The proportions of the three frames can be adjusted by clicking-and-

dragging the frame separator bar between the two frames.

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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.

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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

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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

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.

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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)

Note: 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.

Note: 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

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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

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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

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

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.

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5.4 Tools Menu

Figure 19 - Tools Menu Commands

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

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.

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5.6 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

Table 1 - Quick Guide to eSubmission Builder Functions

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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

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

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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

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

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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 Type

The 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

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.).

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Figure 25 - Attachment Details – Quality Information

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

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.

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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

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.

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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

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




4. Authors



5. Version / Date

The version or Date of the document to be attached. The version is usually included in the



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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

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

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.

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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




4. Authors



5. Version / Date

The Version or Date of the document to be attached. The version is usually included in the




one attachment.

Figure 31 - Attachment Details – Related Ingredients

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.

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Figure 32 - Attachment Details – Document Upload

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.