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Transcript - e-Submission Builder

Description: Cover page - NHP Online Solution. Natural health products licensing made quick, easy and secure.

Narrator: Welcome to the NHPD Web video on the e-Submission Builder. This video tutorial will help provide a general overview of the e-Submission Builder tool and how to use it. This Web video is not meant to provide complete instructions, but to provide an introduction to the tool; it is recommended to read all associated user guides and guidance documents, and attend other webinars and workshops offered by the NHPD.

The e-Submission Builder is available for download from the NHPD web site.

Description: Graphic of the e-Submission Builder application.

Narrator: The e-Submission Builder is a desktop application that you install on your own computer. It is to be used in conjunction with a finalized e-PLA to help you complete your application package to obtain a licence for your natural health product. It is designed to apply the minimum requirements and ensure you have attached all the necessary supporting documentation for your application. Using this tool will help reduce or eliminate refusals for incoming applications.

The e-Submission Builder facilitates the creation of an all electronic Submission Package known as a HCS file. The e-Submission Builder allows users to describe required or optional attachments for example: Cover Letter, Label information, etc., and will automatically include information provided in the completed e-PLA form. Users can then attach the described documents electronically to include them in the e-Submission Package. The electronic portion of the Submission Package is then to be sent to the NHPD.

Initially, the only active area of the e-Submission Builder is a menu bar along with a matching set of command buttons.

Description: Graphic of an arrow pointing to the menu bar.

Narrator: The command buttons will be activated and deactivated to reflect the options available to the user depending on the status of the open Submission Package.

• Create a New Submission Package
• Open a New Submission
• Save a Submission Package
• Close Submission Package
• Add an Attachment
• Delete an Attachment
• And Validate the Submission contents

Description: Graphic of a cursor pointing to each box mentioned above.

Narrator: Once you have opened the e-Submission Builder, you can proceed to either create a new e-Submission Package or a previously saved HCS file for further editing.

To create a new HCS file, click on the New File button. This will open a window to select a finalized Electronic Product Licence Application file. A new HCS file must start by selecting a finalized e-PLA document. You cannot add an incomplete e-PLA. This will give an error message when attempting to add an incomplete e-PLA.

Description: Graphic of the New File button being selected. A window opens and an Electronic Product Licence Application file is selected. The user then clicks on the Open button. A pop-up window appears displaying the following text: "The form has not been finalized". The OK button is selected.

Narrator: The e-Submission Builder works with all application types and will apply the minimum criteria rules based on the application type indicated in the e-PLA.

Description: Graphic of the New File button being selected. A window opens and a finalized Electronic Product Licence Application file is selected. The user then clicks on the Open button. The e-Submission Builder application expands to display additional information.

Narrator: Once an HCS file is created or opened through the e-Submission Builder, the application will expand to display additional information. The e-Submission Builder will expand to 3 viewable frames: the submission details frame, the attachments frame and the attachment details frame. The proportions of these three frames can be adjusted by clicking and dragging the frame separator bar between two frames.

Description: Graphic of arrow pointing to each frame mentioned above. The frame separator bars are clicked and then dragged to adjust the proportions of the frames.

Narrator: The top frame is the submission details frame. This frame displays high-level information contained in the e-PLA file. This frame extracts basic information from the e-PLA including: Primary Brand Name, Tracking Number, Applicant/Company Name, Company Code, Application Type and Dosage Form.

Description: Graphic of arrow pointing to each box mentioned above.

Narrator:

The second frame of the fully expanded e-Submission Builder is the attachments frame.

Description: Graphic of an arrow pointing to the attachments frame.

Narrator: 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. The first step in adding information to a HCS file is to add an attachment to the submission file. This is done by clicking the Add button from the command bar.

Description: Graphic of an arrow pointing to the Add button in the command bar. The Add button is selected. Information is displayed in the attachment details frame.

Narrator: The third frame of the fully expanded e-Submission Builder is the attachment details frame. This frame is used to input information or meta-data about an attachment. To enter information, select the type of attachment that you will be adding by selecting an Attachment Type. Select Attachment Type in the drop-down list, and enter the details in the corresponding fields of the attachment details frame. There is a number of attachment types divided into categories for ease of use. Depending on the type of attachment that the user plans to attach, different meta-data fields will be displayed and required to be entered for corresponding attachments.

Description: Graphic showing a drop-down list under the Attachment Type box. Various selections are made. Each selection changes the meta-data fields displayed.

Narrator: Once the meta-data has been entered, click on the Browse button below to add the document. A window will appear prompting you to select the appropriate document.

Description: Graphic of the Browse button being selected in the attachment details frame. A window opens and a document is selected. The Open button is selected. The document name appears in the Original Document box.

Narrator: Users can continue to add more attachments by selecting Add from the command bar.

Description: Graphic of an arrow pointing to the Add button in the command bar. The Add button is selected. Information about attachments is displayed in the attachments frame.

Narrator: To view document details in the attachment details frame, select the corresponding row in the list of documents frame and the information will be automatically populated in the matching fields.

Description: Graphic of various attachments being selected in the attachments frame. Each selection changes the meta-data fields displayed in the attachment details frame.

Narrator: 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 click on the Save button on the command bar. If you are saving a 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 Number.hcs" and will not give you the option of changing the name.

Description: Graphic of an arrow pointing to the Save button in the command bar. The Save button is selected. A window opens.

Narrator: To open an existing HCS file, click on the Open button. This will open a browse window where you can locate and select the desired HCS file and open it in the e-Submission Builder.

Description: Graphic of an arrow pointing to the Open button in the command bar. The Open button is selected. A browse window opens. The desired HCS file is located and the Open button is selected. This opens the document in the e-Submission Builder.

Narrator: Valid e-Submission Builder files that can be opened in the e-Submission Builder must have a .hcs extension and must have been created using the e-Submission Builder. Based on the details you have entered in the e-PLA, the e-Submission Builder 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.

Description: Graphic of a cursor pointing to a red flag in the attachments frame.

Narrator: Once all the supporting information has been added to the HCS file, you can perform a check on the information by clicking on the Validate button. You will be notified of any blank mandatory fields or missing required documents through a pop-up window. 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. If you receive a notification about a missing mandatory document you must add a document with the required criteria to finalize and submit the HCS file.

Description: Graphic of an arrow pointing to the Validate button in the command bar. The Validate button is selected. A pop-up window appears notifying the user of any blank mandatory fields or missing required documents. The pop-up window is then closed.

Narrator: 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.

Description: Graphic of an attachment being selected in the attachments frame. The Browse button in the attachment details frame is selected. A window opens and a document is selected. The Open button is then selected. The window closes and the document name appears in the Original Document box.

Narrator: Once the HCS file contains all the required documents with all the required information entered, then the large flag at the top in the command bar will turn green. This means that the file contains the required documents and has been validated.

Description: Graphic of an arrow pointing to the large green flag in the command bar.

Narrator: Please ensure the HCS package has been validated within the e-Submission Builder before submitting to the NHPD. Should the HCS package not be validated, then it will be rejected by the NHPD.

A finalized HCS file should be submitted to the NHPD via the PosteCS secure email system for the quickest and easiest processing. Optionally you may submit via CD or DVD, however PosteCS is recommended.

Thank you.

For more information please visit: www.healthcanada.gc.ca/nhponline
or email: nhp_initiative_psn@hc-sc.gc.ca
or email: pla.info.dlmm@hc-sc.gc.ca