Overview

Drug manufacturers and vendors can use DIRECT to submit, manage and track drug submissions to the Ministry of Health.

Benefits of DIRECT

Create new submissions

You can create new submissions online for supported product types, including:

  • single source drug products
  • multiple source drug products
  • biosimilar products, nutrition products
  • continuous glucose monitoring (CGM) products
  • diabetic testing agents
  • valved holding chambers (VHCs)

Vendors may create submissions on behalf of manufacturers.

Manage and track submissions

You can:

  • provide additional information if a submission is incomplete
  • use guideline‑driven forms that ask only for the documents and questions required for the type of submissions you are making
  • submit notifications of change for existing products
  • view and track the ongoing submission status

Extended submission deadlines

If you use DIRECT for new multiple source product submissions, the deadline is 11:59 p.m. Eastern Time (ET) on the published deadline date.

If you use email for new multiple source product submissions, the deadline remains 3 p.m. Eastern Time (ET) on the published deadline date.

Learn more about submission deadline dates.

Improved submission quality and processing

You can:

  • reduce incomplete submissions through integrated guided data entry
  • get instant confirmation that your submission was received
  • quickly access submission guidelines, current announcements and manage contact information

Submit securely and quickly online

You can:

  • confirm attestations instead of providing signed letter templates to simplify submissions
  • submit encrypted sensitive information so you do not need a separate file transfer service or multiple emails for large files

How to access DIRECT

Accessing DIRECT as a manufacturer or as a vendor

User request

I want access to the DIRECT portal

Action

Send email to DIRECT@ontario.ca

  • Subject: DIRECT Access
  • Body: My organization requests access to the DIRECT portal

Next steps

The ministry will provide information regarding DIRECT onboarding and Identity Service Provider (IdP) details via email in approximately 1 to 2 business days

Authentication

Manufacturers and vendors authenticate using a secure Federated Login model with an Identity Service Provider (IdP) (such as Microsoft Azure Active Directory).

An IdP is a service that stores, verifies, and manages a user’s digital identity. It confirms a user’s identity before allowing access to DIRECT and securely shares that verification with the system.

We need information about your organization’s IdP to enable access to the DIRECT portal.

Recommended browsers

The latest version of Chrome, MS Edge, Opera, Firefox or Safari are the recommended browsers for accessing DIRECT. Other browsers are not supported and may lead to unexpected behaviour including the inability to log in or submit.

DIRECT in French

Due to its technical nature and limited targeted audience, this application has been exempted from translation under the French Language Services Act as per O. Reg. 671/92.

Contact us

For enrolment and business-related questions about the DIRECT portal, email DIRECT@ontario.ca .

For technical issues or questions, contact Inquiry Services: