Small business mitigation for drugs and medical devices: Before you apply for or renew small business status

On this page

• Determining your unique identifier
  • What is a unique identifier
  • Finding your unique identifier
  • Receiving a unique identifier if you do not have or cannot find it
• Receiving your activation code
• Registering for a secure web portal account

Determining your unique identifier

What is a unique identifier

Before you can apply for small business status, you’ll need to determine your company’s unique identifier.

Health Canada assigns unique identifiers to every company the first time they formally submit their drugs and medical devices information to us. This may be in the form of a company code, customer number, company identifier or manufacturer identifier.

We assign unique identifiers by product line. Companies receive unique identifiers for each of the product lines where they engage in business with Health Canada.

Health Canada assigns 1 unique identifier per product line for:

• Drug products (including disinfectants, excluding Emergency Drug Release (EDR), Experimental Studies Certificate (ESC), and Veterinary Health Product (VHP) submissions)
• Emergency Drug Release (EDR), Experimental Studies Certificate (ESC), and Veterinary Health Product (VHP) submissions

Companies that engage in business for medical devices may have multiple medical device unique identifiers.

For example:

• If your company has several locations and has submitted multiple MDSAP certificates (corresponding to the different locations), you will have multiple unique identifiers.
• If your company engages in business for both medical devices and human drugs (including disinfectants), it will have 1 unique identifier for human drugs and 1 (or more) unique identifier(s) for medical devices.
• If your company engages in business for both human and veterinary drugs (excluding Emergency Drug Release (EDR), Experimental Studies Certificate (ESC), and Veterinary Health Product (VHP) submissions) it will have 1 unique identifier.
• If your company engages in business for veterinary drugs it will have 2 unique identifiers if it engages in both:
  • Emergency Drug Release (EDR), Experimental Studies Certificate (ESC), and Veterinary Health Product (VHP) submissions
  • All other veterinary drug submissions

Unique identifiers are granted by company name. If your company undergoes a name change, you may receive a new unique identifier.

You are required to submit a separate small business application for each unique identifier where you want to receive a small business fee reduction. To receive a small business fee reduction you must hold valid small business status on the unique identifier that corresponds with your submission, application or notification at the time of filing.

Finding your unique identifier

You can find your unique identifier in the following places:

• Drugs (including disinfectants, except EDR, ESC and VHP submissions):
  • "Company Code” at the top of your Annual Drug Notification Form
  • “Customer Number” at the top of each invoice you receive
  • “Customer Number” at the top of each monthly Statement of Account
  • “Company Identifier” in your Regulatory Enrollment Process (REP) Company (CO) file
    • Note: REP is currently mandatory for all Pre-market evaluation human drug submissions and is in the pilot phase for veterinary drugs.
• Medical Device:
  • “Company / Manufacturer ID” at the bottom of your Medical Device Listing cover page
  • “Company / Manufacturer ID” on the Medical Devices Active Licence Listing (MDALL)
  • “Customer Number” at the top right hand corner of your Establishment Licence invoice
  • “Company Identifier” in your Regulatory Enrollment Process (REP) Company (CO) file
    • Note: REP is currently in the pilot phase for Pre-market evaluation medical device submissions
• Veterinary Drug EDR, ESC and VHP submissions:
  • “Customer Number” at the top of each invoice you receive
  • “Customer Number” at the top of each monthly Statement of Account

Unique identifiers are:

• 6 digit numbers for medical devices
• 5 digit numbers for EDR, ESC and VHP submissions
• 4 or 5 digit numbers for drugs (excluding EDR, ESC and VHP)

When locating your unique identifier for human drugs or medical devices, you may see letters in front of your identifier, for example, DPD, DRSE, DEL, MDE. These are not part of your unique identifier and may differ depending on your submission / application / notification. Do not use the letters when creating or accessing your account. Your unique identifier will remain the same regardless of where you find it.

Receiving a unique identifier if you do not have or cannot find it

If your company has never received a unique identifier for the product line, or is unable to confirm its unique identifier, or requires an additional unique identifier to correspond with a new location (medical device only), please contact us for:

• Veterinary Drugs: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca
• Medical Devices: devicelicensing-homologationinstruments@hc-sc.gc.ca
  • Note: If your company only plans to file Establishment Licence applications, please use the following email address: mdel.application.leim@hc-sc.gc.ca
• Human Drugs (including disinfectants):
  • If your company only plans to file Establishment Licence applications: client.information@hc-sc.gc.ca
  • If your company plans to file a Pre-market evaluation drug submission, you must complete the REP company enrolment process. For information you can request the REP guidance document by emailing no-reply.ereview.non-reponse@hc-sc.gc.ca. Please ensure that the subject line of your email is: “Request for REP Guidance Document - Drugs”.
    • For all questions regarding the REP process, please email: client.information@hc-sc.gc.ca.

If your company is requesting a unique identifier by email (other than for the REP process) please give the:

• Full legal name of the company
• Company’s address
• Contact person information
  • given name and surname
  • position within the company
  • department within the company
  • telephone number
  • fax number (if applicable)
  • email address

Receiving your activation code

Once you have located / received your unique identifier(s) you’ll be able to apply for an activation code. This code will allow you to gain access to the Drug and Medical Device Small Business Application and will help to link your small business application to your company.

If this is your first time requesting an activation code for the Drug and Medical Device Small Business Application, you must first complete a Trading Partner Profile Form.

The person who completes the Trading Partner Profile Form must have signing authority for your company.

To get a copy of the form and to receive your activation code, you can email us at: tpmo-bgpc@hc-sc.gc.ca.

As small business status is granted per unique identifier, when completing your form please provide all of the unique identifiers that you would like to receive small business status on.

When renewing your small business status using your existing secure web portal account you will not be required to re-enter an activation code, as long the information submitted on your Trading Partner Profile Form has not changed.

If any of the information has changed, you are required to submit an additional Trading Partner Profile Form to modify any of the provided information.

Registering for a secure web portal account

Before accessing the Drug and Medical Device Small Business Application, you’ll also need to create a secure web portal account.

This account will use unique electronic credentials to allow you to communicate securely with the Government of Canada.

Companies only need to create a secure web portal account if they do not already have one. Companies that already have a secure web portal account will be able to reuse their login information.

How to register for an account

There are 2 ways you can register:

• Register with a GCKey

This method allows anyone to access government online services by creating a username and password.

OR

• Register with a Sign-In Partner

Use your sign-in information for another online service, for example, online Canadian banking account, to register for a secure web portal account. To use this method you must have an account with one of our Sign-In Partners, such as a major bank.

Register with a GCKey

• Click to access the Secure Web Portal.
• Click Continue to GCKey.
• Read the Terms and Conditions of Use and click “I Accept.”
• Create a username. Click Continue.
• Create a password. Click Continue.
• Create your security questions and responses.
• Click Continue to get to the Sign-Up Complete page.

Register with a Sign-in Partner

• Click to access the Secure Web Portal.
• Click Continue to Sign-in Partner.
• Choose your institution.
  • If you do not see an institution that you already belong to, you need to go back and register with GCKey.
• Enter your sign-in information and click Continue.
• Read the Terms and Conditions of Use and click “I Accept.”
• Enter your information and follow the steps to create your account.

More information

If you have questions about our drugs and medical devices small business fee reduction measures you can reach us at the Small Business Office at sbo-bpe@hc-sc.gc.ca.