Applications and service standards for drug establishment licences (GUI-0127): How to prepare and submit a DEL application

On this page

• Preparing a DEL application
• Submitting a DEL application

Preparing a DEL application

Before you start

Deficiencies in drug establishment licence (DEL) applications cause delays in processing as they result in deficiency notices and a pause to the application clock. It’s your responsibility to understand the regulatory requirements before preparing an application so Health Canada can perform a timely and efficient review of your application.

Before preparing an application, review the references and thoroughly read the:

• instructions provided in the Drug establishment licence application form (FRM-0033)
• Guidance on drug establishment licences (GUI-0002)

For detailed information on deficiency triggers, refer to the page on Deficiencies.

You are encouraged to email Health Canada for any questions on the DEL application requirements: del.questions-leppp@hc-sc.gc.ca.

Small business registration

You must obtain or renew your small business status before you:

• submit an application for a new DEL
• request reinstatement
• request reactivation
• add a new domestic building
• submit an application for annual licence review (ALR)

For more information on small business status and DEL fees, consult:

• Fees for the review of human and veterinary drug establishment licence applications

Application submission best practices

Health Canada only issues 1 decision for each application regardless of how many amendment requests are included in the application. For example, if an application contains amendments for several buildings, we will only issue a decision after the GMP compliance review of all buildings is completed and we have rendered a decision for all buildings.

However, in the following cases, you are encouraged to submit 1 application, including all of the sites and activities that require approval, before activities can commence. They should be grouped into 1 application, as all sites and activities must be approved before activities can begin.

New DELs:

• New DEL applications should include every Canadian and foreign building for which a licence is required in 1 application. The submission of multiple forms is permitted to capture all requested information within the same application.

Activity of import:

• Applications for adding or modifying import activities should include amendments to the domestic building as well as the foreign buildings associated with the importation.
  • For finished dosage form (FDF) importations, this may include amendments to the domestic building, the Foreign Building Annex and, if applicable, the Active Pharmaceutical Ingredient (API) Foreign Building Annex for foreign buildings that conduct activities with APIs.
  • For API importations, this may include amendments to the domestic building and the API Foreign Building Annex for foreign buildings that conduct activities with APIs.

Note: If a new FDF class will be imported, you should include a request to add the new class in Section 3.0 of FRM-0033. If it was already submitted, include a reference to the application number in your application.

Adding or amending foreign buildings to the Foreign Building Annex:

• Applications for adding or amending a foreign building to the Foreign Building Annex should include a Table A for all associated API foreign buildings that conduct activities with APIs at the time of submission, as applicable.

Adding or amending API foreign buildings on the API Foreign Building Annex:

• Applications for adding or amending information to the API Foreign Building Annex should include all required changes indicated in Table A.
  • The Table A form application can be used for amendments to both the API foreign buildings from which APIs are imported and the sources of API used by a foreign fabricator of a FDF product that will be imported into Canada.  
  • Additional clarification should be included in the cover letter for complex changes. 
• For sources of API used by a foreign fabricator of an FDF product, if you wish to add a new API foreign building to the DEL, the foreign building identified as the FDF fabricator of the product must already be listed on the Foreign Building Annex or must be requested as part of the amendment application.

Cover letter

Health Canada strongly recommends submitting a cover letter with your application. It can be included as an email or a separate document with your submission. A cover letter helps to:

• provide context on what is being requested in your application
• ensure efficient processing of your application
• reduce deficiency notices

Include the following information in your cover letter:

• name of company on the DEL and its DEL number (if assigned or previously assigned)
• application number (if assigned)
  • important to include this number when providing supplementary information to an application under review
• important context, including:
  • if an expedited review is requested (refer to the section on Expedited reviews to confirm if your application is eligible)  
  • what is requested in the application, such as:
    • adding a foreign building to the Foreign Building Annex
    • adding a new drug category to the domestic building
  • list of supporting documents provided as part of the application, such as:
    • GMP evidence submitted as per How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
  • information on the nature of the changes if related to an amalgamation or acquisition
• a copy of relevant correspondence if specific guidance was provided by Health Canada before filing your application
• rationale for any discrepancy of foreign building name and address listed on the FRM-0033 versus the supporting GMP evidence, such as:
  • site master file (SMF) or certificate of compliance (CoC) and equivalent inspection report
• any additional information you would like to provide to support the application

Submitting a DEL application

The DEL process starts when a complete application is submitted using 1 of the methods outlined in the following sections.  

The “date of receipt” for an application is either the:

• date the application is received by email
• manual date stamp on an application received by mail

Health Canada:

• will only accept the most current version of FRM-0033
• recommends you use the most recent version of the Table A form, which can be requested by emailing del.questions-leppp@hc-sc.gc.ca
• will not accept documents submitted through third-party websites

DEL applications that are submitted electronically can be processed more efficiently. We also recommend that you use the fillable PDF FRM-0033 when completing your application.

If you wish to withdraw an application, send your request to del.questions-leppp@hc-sc.gc.ca and include the application tracking number (if assigned). The request must come from an authorized contact on file for the DEL or include an authorized contact on the request.

Submitting by email

To submit an application electronically, email the completed application and all supporting documents to el.applications-le@hc-sc.gc.ca.

We strongly encourage that you exclusively email your application to this email address. There is no requirement to copy other Health Canada email addresses unless you are requested to do so.

A system-generated auto-response will be sent to confirm that the application was successfully delivered. You should save both the submission email and the auto-response for reference.

Note: If you do not receive an auto-response from Health Canada following your submission, it means the application was not delivered. Verify the email address and resubmit the application along with all supporting documents.

Best practices when submitting an application with large attachments:

There may be an attachment size limit when submitting by email. If your application contains many large attachments , we recommend sending multiple emails and using the same subject line for each email submission. If not feasible, email us for support: del.questions-leppp@hc-sc.gc.ca.

Indicate the number of parts in the email subject line to ensure we can efficiently identify and process your submission:

Example:

• subject line for first email: Part 1 of 2 - DEL #XXXXXX-X - Renewal of Foreign Building
• subject line for second email: Part 2 of 2 - DEL #XXXXXX-X - Renewal of Foreign Building

If you would like to submit password protected documents, include a password in a separate email.

The receipt date for the application will be entered as the date when we received the last portion of the application or the password, as applicable.

In addition to the auto-response following the initial email submission, you should receive an “acknowledgement of application acceptance notice” or “application completion notice” from Health Canada within 20 calendar days.

If you do not receive such correspondence within 20 calendar days, you may follow up with us to inquire about the status of your application. Email us at del.questions-leppp@hc-sc.gc.ca.

Submitting by mail

To submit an application by mail, identify all forms and supporting documents in a cover letter.

Mail to:

Drug Establishment Licensing Unit
Jeanne Mance Building
200 Eglantine Driveway
Address Locator #1913B
Ottawa ON  K1A 0K9

Note: Health Canada does not accept applications submitted on portable storage devices such as universal serial bus (USB) memory sticks, external hard drives and secure digital (SD) cards. However, we do accept applications submitted on a compact disc (CD) or digital video disc (DVD).

You should receive an “acknowledgement of application acceptance notice” or “application completion notice” email from Health Canada when submitting by mail. If you do not receive such correspondence within 20 calendar days of delivery, you should follow up with us to ensure your application was received. Email us at del.questions-leppp@hc-sc.gc.ca.