Natural Health Products Online eSubmission Builder - Health Canada
The NHP Online eSubmission Builder (eSB) is a software application that can be downloaded 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 (e-PLA) 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) for full electronic processing by the NNHPD.
- 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 e-PLA.
- The eSB facilitates the attachment of the described documents electronically to include them in the Submission Package.
- The eSB generate a unique Submission Package Tracking number using the e-PLA tracking number for reference purposes.
Additional information on how to interact with the electronic submission builder program along with step by step assistance on using its features can be found in the Natural Health Products Online System Electronic Submission Builder User Manual.
Quickstart to the eSubmission Builder (eSB)
The general process for using the eSB to submit submission packages to Natural and Non-prescription Health Products Directorate (NNHPD) is as follows:
- Create a submission file:
Load a finalized e-PLA. Specify pertinent supporting documents based on the information within the e-PLA. 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.
- 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.
- 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.
For additional information, please see the Natural Health Products Online System Electronic Submission Builder User Manual.
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 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. The Electronic Submission Builder program doesn't work on Mac machines. 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
Downloading the eSubmission Builder Application
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
When you click on the zip file, 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.
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