Natural Health Products Online Solution: Electronic Submission Builder User Manual

Transcription

1 Natural Health Products Online Solution: Electronic Submission Builder User Manual

2 Table of Contents 1 Introduction Overview Quickstart to the esubmission Builder (esb) System Requirements MANDATORY Requirement Downloading the esubmission Builder Application Installing the esubmission Builder Application Un-Installing the esubmission Builder Application esubmission Builder Introduction Submission Details Frame Attachments Frame Attachment Details Frame Building an Electronic Submission Package (a Finalized HCS File) Creating a new esubmission Builder File (HCS File) Opening an Existing esubmission Builder File (HCS File) Adding Information to an esubmission Builder File Saving an esubmission Builder File Validating an esubmission Builder File Submitting the esubmission Builder Submission Package Menu Commands and Command Buttons File Menu Edit Menu View Menu Tools Menu Help Menu Quick Guide to esubmission Builder Functions Field Definitions and Usage Fields within the Submission Details Frame Fields within the Attachments Frame Fields within Attachments Details Frame Version 1.0 Page ii

3 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 Version 1.0 Page iii

4 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 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 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 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 (PosteCS) or store to a user-defined medium (e.g., CD, DVD) and mail it to NHPD. Version 1.0 Page 4

5 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. Version 1.0 Page 5

6 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 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 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. Version 1.0 Page 6

7 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 Setup.exe. 2.3 Installing the esubmission Builder Application To start the installation process simply double click on the SubmissionBuilder 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. Version 1.0 Page 7

8 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. Version 1.0 Page 8

9 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. Version 1.0 Page 9

10 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 Version 1.0 Page 10

11 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 Version 1.0 Page 11

12 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. Version 1.0 Page 12

13 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 Version 1.0 Page 13

14 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-anddragging the frame separator bar between the two frames. Version 1.0 Page 14

15 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. Version 1.0 Page 15

16 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 Version 1.0 Page 16

17 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 nonmandatory 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 nonmandatory. 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 (requires enrolment) or on CD-ROM, DVD-ROM. Version 1.0 Page 17

18 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. Should the HCS package not be finalized, then it will be rejected by 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 Version 1.0 Page 18

19 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 Version 1.0 Page 19

20 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. Version 1.0 Page 20

21 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. 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. Version 1.0 Page 21

22 5.6 Quick Guide to esubmission Builder Functions Function Menu Item Keyboard Shortcut Create a New Submission File / New Package (HCS file) Alt + N Command Button Open an Existing Submission Package (HCS file) Close an Open Submission Package (HCS file) Save a Submission Package (HCS file) Save a Submission Package (HCS file) with a new name Close the esubmission Builder File / Open File / Close File / Save File / Save In File / Exit Alt + O Alt + S Alt + X Add an Attachment to the List of Attachments Frame Remove an Attachment from the List of Attachments Frame Hide or Show the Command Menu Bar Hide or Show the Submission Details Frame Hide or Show the Attachment Details Frame Edit / Add Edit / Delete View / Hide-Show Command menu bar View / Hide-Show Submission Details View / Hide-Show Attachment Details Alt + A Alt + Delete 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 Version 1.0 Page 22

23 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 Version 1.0 Page 23

24 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 Version 1.0 Page 24

25 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.). Version 1.0 Page 25

26 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. Version 1.0 Page 26

27 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. Version 1.0 Page 27

28 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 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 Version 1.0 Page 28

29 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 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. Version 1.0 Page 29

30 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 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. Version 1.0 Page 30

31 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. Version 1.0 Page 31