Narrator: This video provides a demonstration of how tocreate a new drug submission for a single sourcedrug product in DIRECT, the Drug Intake, Review,Evaluation, Contracts, and Transactions portal.All drug names, details, and accounts shown inthis video are fictional. This demonstrationserves as an example only and does not exploreall possible variations.
Please refer to the user guide and submission guidelines for moredetails that may be relevant for your submission.
As a drug manufacturer or vendor, you have loggedin and selected the Create Submission button.The Submission Overview screen displays.First, indicate who the submission is being created for. In this example, you area drug manufacturer submitting for your own organization, and you'll need to selectthe Submission Category, Product Type, and Submission Type from the drop-down values.Select the Applicable Guidelines link, if desired, to access the relevantGuidelines as a PDF document.Click the Next button and the ManufacturerDetails screen displays. Note that you cansave your work at any time by clickingSave.
This will create a draft that youcan return to and continue working on later.You must provide information in the requiredfields in each of the screens shownin the left menu, before submitting.Scroll down to the Primary ContactInformation section and selectthe Primary Contact for this submission.
The selected contact s information displays.
You can select the Manage Contact Listbutton to view, edit, or add contacts.Click Next.
The Product Details screendisplays and is bolded in the left menu.After completing the required details, there isnow a green checkmark beside Manufacturer Details.
DIRECT guides you as screens are completed,using green checkmarks as a visual indicatorthat required details have been provided.
Enter the product details as they appear inHealth Canada documentation. If necessary,you can click the Add Product link to enteradditional products.
Click in the Product Name field and enter the details.
Click in the Active Ingredient(s) field and enter the information.
If appropriate, click in the Identifier Type drop-down field and selectthe value Drug Identification Number.The Identifier field displays. Enter the DIN.Click the Dosage Form drop-down and select theapplicable value. Note that if the correctvalue cannot be located in the drop-down, choose 'Other' and you will be ableto enter the value as free text.
Click in the Strength field andenter the drug's strength(s).
Click in the Route of Administrationdrop-down field and select the applicable value. If necessary, choose 'Other'to enter the value as free text.
Select the required radio button to indicate whether the product is preservativefree or with preservative for injectable and ophthalmicproducts, otherwise select 'Not Applicable'.
Select the required radio buttons in the ProductClassification section to indicate if the product is a biologic, and if the indication(s)for the submission is oncology-related.Enter the required details in thePackaging and Pricing section.After entering the packaging and pricinginformation, click the Next button to continue to create the submission.The Submission Details screen displays and is bolded in the left menu.
Select the appropriate value in the Requested Funding, Listing, Program section.Multiple values can be selected, if appropriate.Select the Health Canada Indication(s) fieldand enter the details, then click the Next button to continue to create the submission.The Health Canada Documentation screen displays and is bolded in the left menu.
Select the appropriate radio button for the question: Are any of theproducts on this submission Pre-NOC?If selecting No to the question, selectthe Add Notice of Compliance link.Enter the appropriate date in theNOC Approved Date field and enter the value in the Submission Control Number field.Then, upload the Notice of Compliance file.Note that throughout DIRECT, multiple filescan be uploaded by dragging and dropping them, or by clicking the Browse Files option.In the Product Monograph Information section,provide details for the current ProductMonograph approved by Health Canada.Select the Add Product Monograph link.Enter the appropriate date in the Dateof Product Monograph Revision field and enterthe value in the Submission Control Number field.Upload the Product Monograph file.Click the Next button to continueto create the submission.The Clinical Evidence / Studies screendisplays and is bolded in the left menu.
Select the appropriate radio buttons.If selecting Yes to the question:
Is the Common Technical Document available? theCommon Technical Document(s) section displays.
Upload the Common Technical Document(s)file(s) in the required fields.Click the Next button to continueto create the submission.
The Financial Impact Analysis screendisplays and is bolded in the left menu.Upload the Financial Impact Analysisfile(s) in the required fields.Click the Next button to continueto create the submission.The Pharmacoeconomic Analysis screendisplays and is bolded in the left menu.Upload the Pharmacoeconomic Analysisfiles in the required fields.Click the Next button to continueto create the submission.The Supplemental Information screen displaysand is bolded in the left menu.
This optional screen is available to provide any additionalinformation and/or materials that may aid theministry in assessing your submission.
Upload any supporting documents, and/orenter supplemental information, if desired.
Click the Next button or the Attestations tab to continue to create the submission.
The Attestations screen displays and is bolded in the left menu.
Review and click to select checkmarks for each attestation.
Note that while you can choose to click the Submit button from many screens, itis recommended to first review information on the Review screen, which summarizes yoursubmission and highlights any required information that hasn't yet been provided.
If you do click Submit and you have not provided all required information, a rationalewindow displays. In situations where required information cannot be provided due to exceptionalcircumstances, you can enter the reason.
In this case, you have forgottento add an attachment, so you'llneed to click the Edit Submission button.
It is highly recommended to review all information before submitting, because you cannot edit asubmission through DIRECT after it is submitted.The Review screen displays. Click the SubmissionSummary link to expand the screen to show all information that has been entered, includingall attachments. Any required information that has been missed will be highlighted.
Note that information that has been flagged as missing appears in red font withan exclamation mark in the Left Menu.
You can jump to the area by clicking on thelink. Then you can upload the missing file.If all required information for thesubmission has been entered, greencheckmarks appear for each page in the Left Menu.
Note that some fields are noted as Optional,while others are Required. Certainrequired fields are mandatory to submit,for example the Primary Contact.
Click the Submit button.
DIRECT validates responses and highlightsany items requiring review/update.The Submitting Terms and Conditions display.Review the terms and conditions, and ifdesired, click the Accept button.A pop-up message indicates that thesubmission has been successfully submitted.
The initial submission date is provided,along with the Primary File Number that has beengenerated. You can download a PDF summary of thesubmission by selecting the click here link,and a copy is available anytime by selectingthe View button in the Correspondence sectionfor the submission, on the Submissions List.
Select the OK button to return to thesubmission list.
The submission now appears in the submission list with a status of Submitted.
You have successfully submitted to the ministry.Find links to other learning resources onour training aids page at Ontario.ca/DIRECT.
Have questions or want to register?Email us at DIRECT@ontario.ca.