Narrator: This video provides a demonstration of how to create a new notice of change submission in DIRECT, the Drug Intake, Review, Evaluation, Contracts, and Transactions portal. All drug names, details, and accounts shown in this video are fictional. This demonstration serves as an example only and does not explore all possible variations.
Please refer to the user guide and submission guidelines for more details that may be relevant for your submission. As a drug manufacturer or vendor, you have logged in and selected the Create Submission button. The Submission Overview screen displays. Select the default radio button to indicate the new notice of change submission isbeing created for your organization.
Click the Submission Category drop-down and select, Notice of Change.
Click the Product Type drop-down and select the product type for the submission that requires a change. Click the Change Type drop-down and select the value for the type of change being requested. Note that the submission requirements differ depending on the change type and the product type. Select the Applicable Guidelines link, if desired, to access the relevant Guidelines as a PDF document. Click the Next button. The Manufacturer Details screen displays.
Note that you can save your work at any time by clicking Save. This will create a draft that you can return to and continue working on later.
You must provide information in the required fields in each of the screens shown in the left menu, before submitting.
Scroll down to the Primary Contact Information section and select the Primary Contact for this submission. The selected contact s information displays.
You can select the Manage Contact List button to view, edit, or add contacts. Click Next.
The Product Details screen displays and is bolded in the left menu. After completing the required details, there is now a green checkmark beside Manufacturer Details. DIRECT guides you as screens are completed, using green checkmarks as a visual indicato rthat required details have been provided. Enter the product details as they appear in Health Canada documentation.
If necessary, you can click the Add Product link to enter additional products. Click in the Product Name field and enter the details. Click in the Active Ingredients field and enter the information. If appropriate, click in the Identifier Type drop-down field and select the value Drug Identification Number.
Note, this field is optional for this submission. The Identifier field displays. Enter the DIN.
Click the Dosage Form drop-down and select the applicable value.
Click in the Strength field and enter the drug's strengths.
Click in the Route of Administration drop-down field and select the applicable value.
Select the required radio button in the Preservatives field to indicate whether the product is preservative free or with preservative for injectable and ophthalmic products, otherwise select 'Not Applicable'. Select the required radio buttons in the Product Classification section to indicate if the product is a biologic, and if the indication for the submission is oncology-related. Select the Next button to continue to create the Notice of Change submission. The Change Details screen displays and is bolded in the left menu. In the Rationale for the changes field, supporting documents can be added by dragging and dropping them, or by clicking the Browse Files option.
Multiple files can be uploaded, if necessary. Enter the appropriate date in the Effective date for the change field and then click the Next button to continue to create the Notice of Change submission. The Health Canada Documentation screen displays and is bolded in the left menu. Select the checkmark to confirm that Health Canada has approved the changes. Select the Add Notice of Compliance link.
Enter the appropriate date in the New NOC or NOL Approved Date field and enter the value in the New NOC or NOL Control Number field. Then, upload the Notice of Compliance file or the No Object Letter file. Note that throughout DIRECT, multiple files can be uploaded by dragging and dropping them, or by clicking the Browse Files option. Select the Add Product Monograph link.
Enter the appropriate date in the Date of the new Product Monograph field and enter the value in the New Product Monograph Control Number field.
Upload the Non-annotated copy of the new Product Monograph file and the Annotated/tracked copy of the new Product Monograph file. Click the Next button to continue to create the Notice of Change submission. The Supplemental Information screen displays and is bolded in the left menu. This optional screen is available to provide any additional information and/or materials that may aid the ministry in assessing your submission.
Upload any supporting documents, and/or enter supplemental information, if desired.
Note that while you can choose to click the Submit button from many screens, it is recommended to first review information on the Review screen, which summarizes your submission and highlightsany required information that hasn't yet been provided.
It is highly recommended to review all information before submitting,
because you cannot edit a submission through DIRECT after it is submitted. Click the Next button to continue to create the submission.
The Review screen displays. Click the Submission Summary
link to expand the screen to show all information that has been entered, including all attachments. Any required information hat has been missed will be highlighted. If all required information for the submission has been entered, green checkmarks appear for each page in the Left Menu.
If required information for the submission has not been entered, when you click the Submit button, a Rationale Required window displays, and a red exclamation mark appears for each page missing information in the Left Menu.
You can provide an explanation and continue to submit the submission, or you can edit the submission and enter the missing information.
Note that some fields are noted as Optional, while others are Required.
Certain required fields are mandatory to submit, for example the Primary Contact. Click the Submit button.
DIRECT validates responses and highlights any items requiring review/update. The Submitting Terms and Conditions display.
Review the terms and conditions, and if desired, click the Accept button.
A pop-up message indicates the submission has been successfully submitted.
The initial submission date is provided, along with the Primary File Number that has been generated.
You can download a PDF summary of the submission by selecting the click here link, and acopy is available anytime by selecting the View button in the Correspondence section for the submission, on the Submissions List.
Select the OK button to return to the submission list.
The submission Status is Submitted and the Submission Category is Notice of Change.
You have successfully submitted the Notice of Change submission to the ministry.
Select the View button to view a record of the submission including the Submission Category, Change Type and Product Type. In the Correspondence History section,select the Download button to download a PDF copy of the Notice of Change submission.
Find links to other learning resources on our training aids page at Ontario.ca/DIRECT.
Have questions or want to register? Email us at DIRECT@ontario.ca.