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Transcript - Electronic Product Licence Application Form (e-PLA)

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

Narrator: Welcome to the NHPD Web video on the Electronic Product Application form known as the e-PLA. This video tutorial will help provide a general overview of the e-PLA and some of its main features. It is recommended to read all associated user guides and guidance documents, and attend other webinars and workshops offered by the NHPD.

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

Description: Graphic of Part 1 - Product Licence Application Form - Applicant and Contact Information.

Narrator: The e-PLA form is for Natural Health Product Licence Applications. The e-PLA is designed to be completed on your computer where it can be saved and retrieved at any time. Through an active Internet connection, the form will automatically access the Natural Health Products Ingredients Database (NHPID) to provide drop-down selections of medicinal and non-medicinal ingredients and related information. This link to the NHPID in the e-PLA form greatly reduces the possibility of deficiencies and/or refusals of NHP applications.

The NHPD is regularly updating the e-PLA form to add new features and to improve efficiency. New releases are announced in advance; however it is always a good practice to check the NHPD web site regularly for the latest version of the e-PLA. The version of the e-PLA can be found at the bottom left corner of the e-PLA form.

Description: Graphic of the bottom left hand corner of the form showing version number.

Narrator: You must always save the e-PLA to your workstation and never work on the version through the internet browser.

Description: Graphic of Part 1 - Product Licence Application Form - Applicant and Contact Information.

Narrator: The e-PLA form is a smart PDF form that is continually applying validation rules to ensure that the information being captured is as accurate as possible. It is always a good idea to save your work frequently. You can always open the saved form at a later time and resume your work.

The e-PLA form is divided into five parts which are completed progressively. When Part 1 is completed, Part 2 is displayed and so on.

Part 1 - Applicant and Contact Information.

Description: Graphic scrolling through each section of Part 1.

Narrator: This section captures all the necessary company and contact information for the application. A part is completed successfully when the Continue button is selected and no errors are found.

Description: Graphic of the bottom of the form.

Narrator: The Continue button then transforms into a Modify Form button, and the completed part is locked to prevent further changes and the next part is displayed.

Description: Graphic of the Modify Form button in the bottom right hand corner of the form.

Narrator: To unlock a completed part to make changes, select the Modify Form button.

Description: Graphic of the Modify Form button being selected.

Narrator: It will transform back into a Continue button and make previous parts eligible for update.

Description: Graphic of the Continue button.

Description: Graphic of Part 2 - Product Licence Application Form - Application Type

Narrator: This section captures the type of application. Select from the drop-down with the following choices:

  • Compendial
  • Compendial from Generated Monographs
  • NHPD Labelling Standard
  • Homeopathic Medicine Labelling Standard (HMLS)
  • Homeopathic Medicine with Specific Claim
  • Homeopathic Medicine with Non-Specific Claim
  • Non-Traditional
  • TPD Category IV/Labelling Standard
  • Traditional

Description: Graphic of screen scrolling through the available application types.

Narrator: Part 3 - Site Information

This section captures all the necessary site information regarding this product.

Description: Graphic of Part 3 - Product Licence Application Form - Site Information. Continue button being selected in bottom right hand corner of the form.

Narrator: Part 4 - Product Information

Description: Graphic of Part 4 - Product Licence Application Form - Product Information.

Narrator: This is the major section of the e-PLA. It captures the product information required by the NHPD for its assessment. The e-PLA dynamically connects with the Natural Health Products Ingredients Database to obtain information related to standard terminologies for natural health products such as medicinal and non-medicinal ingredients, dosage forms, routes of administration, and units.

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

Narrator: The Natural Health Products Ingredients Database information on monographs is also accessed when applicable through the Compendial from Generated Monograph application type.

You can select the ingredient information in the e-PLA through the ingredient search tool. To search for an ingredient, enter a keyword and click Search.

Description: Graphic of arrow pointing to the Search Ingredient Database box on the form. Box is selected. Screen displays Search Ingredient Database, including keyword and search button. Keyword entered and Search button selected. A screen appears with hyperlink information for the ingredient name selected.

Narrator: Selecting the hyperlink, More Details, on the right shows the detailed information of the ingredient found in the NHPID through the Web browser.

Description: Graphic of arrow pointing to More Details hyperlink.

Narrator: Selecting the hyperlinked ingredient name on the left fills the related fields in the e-PLA.

Description: Graphic of More Details hyperlink being selected. The NHPID is displayed through the Web browser, showing detailed ingredient information. The Web browser is closed. An arrow points to the hyperlinked ingredient name in the left hand corner of the screen. Ingredient hyperlink is selected. Screen displays Part 4 with ingredient information filled in.

Narrator: Once an ingredient has been selected you will continue to fill out the necessary information regarding the ingredient such as quantity, source material and method of preparation.

The e-PLA dynamically changes based on the information you select for an ingredient.

Description: Graphic showing drop-down list under the Add a Method of Preparation box. Selection is made.

Narrator: Depending on the information in the e-PLA, additional forms may be appended. If indicated that animal tissues were used in the processing of the product, or if an ingredient contains animal tissues, the Animal Tissue Form will automatically be added to the e-PLA and will require completion to be able to finalize the form.

Description: Graphic of arrow pointing to the Animal Tissue box. Yes is selected. A pop-up window appears displaying the following text: "An Animal Tissue Form has been appended to this document, and will require completion in order to submit the Product Licence Application form." OK button is selected and the Animal Tissue Form is displayed.

Narrator: The same ingredient search tool is used for non-medicinal ingredients.

Description: Graphic of Part 4 of the Product Licence Application Form with arrow pointing to Search Ingredient Database box.

Narrator: The next major section of Part 4 is the Recommended Conditions of Use.

Description: Graphic of screen moving to top of Part 4 of the form.

Narrator: This is where information such as recommended use or purpose is input, along with sub-population groups and dosing information. All risk information is to be entered in this section as well.

Description: Graphic of arrow pointing to each box mentioned above. Screen scrolls to the bottom of the form.

Narrator: Once you have entered all your product information in your e-PLA you will click on the Continue button.

Description: Graphic of Continue button in bottom right hand corner being selected.

Narrator: The form will then do a validation check to ensure that you have entered information in all the required fields. If some fields have been missed a pop-up message will appear informing you that some required fields have been missed.

Description: Graphic of pop-up message box displaying the following text: "Some required fields have not been filled. Please read the agreement above and check "I agree" to proceed." The OK box is selected.

Narrator: The form will then highlight those fields for completion.

Description: Graphic of highlighted information to be filled in.

Narrator: Part 5 - Label Text.

The Label Text Editor tool provides the opportunity to review and possibly edit a generated label text or, alternatively, indicate that the label text will be provided separately along with the e-PLA form.

Description: Graphic of Part 5 - Product Licence Application Form - Label Text. Arrow pointing to the Label Text Submitted Separately box.

Narrator: If the generated label text approach is chosen, the text must be successfully validated before the e-PLA form can be finalized.

Description: Graphic of the Edit Label Text box being selected. The Proposed Regulatory Label Text Form is displayed.

Narrator: This part helps to ensure that all the labelling text requirements will be met as text is assembled directly from the information entered in the e-PLA.

Description: Graphic of screen scrolling to the bottom of the Proposed Regulatory Label Text Form. The Validate box is selected. An arrow points to Label Text Validation completed. The Close button is selected. Part 5 of the Product Licence Application Form is displayed.

Narrator: Once all parts of the e-PLA have been validated, the Attestation box will appear.

Description: Graphic of the Continue button being selected. The form is displayed showing the Attestation box. The I Agree box is selected and an Attestation Code Number is generated within the box.

Narrator: Once the attestation has been agreed to the Finalize button appears at the end of the form after all the sub-forms.

Description: Graphic of the Finalize button in bottom right hand corner being selected.

Narrator: Once all finalization issues are resolved, the form finalization displays at the top and bottom of the form and a unique tracking number is generated.

Description: Graphic of Part 1 of Application Form displayed indicating tracking number in the top right hand corner.

Narrator: Now the form is ready to be saved and then submitted to NHPD along with all your supporting documentation preferably by using the e-Submission builder and the Canada PosteCS secure e-mail system. NHPD will not accept un-finalized e-PLAs.

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

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