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

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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:

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

For example:

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:

Unique identifiers are:

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 addition unique identifier to correspond with a new location (medical device only), please contact us for:

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

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 receiving 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: hc.tpmo-bgpc.sc@canada.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:

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

OR

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

Register with a Sign-in Partner

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 hc.sbo-bpe.sc@canada.ca.

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