Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

Frequently Asked Questions - Drug Establishment Licensing and Fees

Table of Contents

 

Who is required to hold a Drug Establishment Licence (DEL)?

1. What is a drug?

For establishment licensing a drug means:

  • a drug in dosage form (example: tablet, capsule, solution etc.)
  • the intermediate product or substance that can be used in the preparation of a drug. For pharmaceuticals, this would be an active pharmaceutical ingredient (API) for human use only. For Schedule C (radiopharmaceutical) or Schedule D (biologics), this would be a bulk process intermediate.

Reference: C.01A.001 (2) of the Next link will take you to another Web site Food and Drug Regulations (FDR)

2. What is a DEL?

A DEL is a licence issued to a person in Canada allowing them to conduct licensable activities in a building which has been inspected and assessed as being in compliance with the requirements of Divisions 2 to 4 of the Food and Drug Regulations.

3. Who is required to hold a DEL?

A person who wishes to perform the following activities requires a DEL.

  • A person who wishes to fabricate, package / label, test, import, distribute, or wholesale in Canada a finished dosage drug or bulk process intermediate is required to hold a DEL; and
  • A person who wishes to fabricate, package / label, test or import in Canada an active pharmaceutical ingredient is required to hold a DEL.

For the above, the buildings where these activities occur must undergo inspections to show compliance with Good Manufacturing Practices (GMP) standards as outlined in Division 2 of the FDR.

4. Are the licensable activities different based on the category of drug?

Yes.

The licensable activities for Finished Dosage Forms, including bulk process intermediates are:

  1. Fabricate
  2. Package/Label
  3. Test
  4. Import
  5. Distribute
  6. Wholesale

The licensable activities for APIs are:

  1. Fabricate
  2. Package/Label
  3. Test
  4. Import

Note: In regards to both finished dosage forms and APIs, the buildings where these activities occur in Canada must undergo inspections to show compliance with GMP standards as outlined in Division 2 of the FDR. Although wholesaling and distribution of APIs are not licensable activities the buildings where these activities occur in Canada are subject to the Good Manufacturing Practices (GMP) requirements outlined under Division 2 of the FDR.

5. What activities do not require a DEL?

While the following activities do not need a DEL, GMP and other licensing requirements under the Food and Drugs Act and its associated Regulations may be applicable.

  1. Storage / transportation of drug products
  2. Distribution of over-the-counter (OTC) products by non-DIN owners
  3. Wholesaling of OTC, ethical, non-scheduled drugs or drug premixes
  4. In-pharmacy compounding of drug products
  5. Activities pertaining to APIs solely used in veterinary products
  6. Distribution of APIs
  7. Wholesaling of APIs
  8. Activities pertaining to Natural Health Products (NHPs)
  9. Activities pertaining to Medical Devices
  10. Activities pertaining to Food
  11. Activities pertaining to Hard Surface Disinfectants
  12. Activities pertaining to Clinical Trial Drugs

6. Is a DEL required for licensable activities relating to combination products such as Drug-Medical Devices or Drug-Natural Health Products?

Yes. A DEL is required for licensable activities pertaining to the drug portion of a drug-medical device combination product, and a Medical Device Establishment Licence (MDEL) is required for licensable activities pertaining to the medical device portion.

For more information on Medical Device Establishment Licensing, please see the Frequently Asked Questions - Medical Device Establishment Licensing and Fees

For the NHP Site Licensing requirements of the Natural Health Product portion of a combination product please contact the Natural Health Products Department (NHPD) at:
E-mail: nhpd_dpsn@hc-sc.gc.ca or sla.info.dle@hc-sc.gc.ca
Facsimile: 613-948-6810
Telephone: 613-960-8827
Teletypewriter: 1-800-267-1245 (Health Canada)

7. Does a Canadian DIN owner require a DEL?

Yes. At a minimum, a Canadian DIN owner must be licensed for the activity 'distribute'. If additional activities are performed they must also appear on the licence. This applies to finished dosage forms only.

8. My establishment is located outside of Canada and I wish to sell my products in Canada. Do I need a DEL?

No. The FDR applies only to buildings located in Canada. Foreign buildings who wish to sell drugs in Canada are required to demonstrate compliance to the GMP requirements outlined in Division 2 of the FDR, and must be listed on an importer's DEL.

For additional questions with regards to GMP requirements for a foreign building please contact the GMP unit at foreign_site_etranger@hc-sc.gc.ca directly.

9. How would I know if I am a distributor or a wholesaler?

If you are selling a drug (whether it is a drug in dosage form or an active ingredient) under a name/brand/etc. controlled by you, then you are a distributor.

If you are selling a drug (whether it is a drug in dosage form or an active ingredient) under a name/brand/etc. that is not controlled by you, then you are a wholesaler unless:

  • you sell only at retail or
  • you sell only dosage-form over-the-counter drugs.

Reference: Distribute: A.01.010, C.01A.003, wholesale: C.01A.001 (1) (Food and Drug Regulations)

10. Is sterilization of primary packaging materials a licensable activity?

Yes. The activity of sterilizing packaging materials used in the preparation of aseptically filled sterile products is considered a licensable activity (specifically, fabricate). An establishment licence is required for conducting the aforementioned licensable activity. DEL holders utilizing foreign establishments for sterilization must ensure that these foreign buildings are listed on their DEL and comply with Good Manufacturing Practices (GMP) requirements outlined under Division 2 of the FDR.

11. What is a warehouse?

A warehouse is any Canadian building used to store drugs.  All warehouses must be listed in Part C of the form FRM-0033. They will be listed on the Warehouse Annex of the DEL.

12. Do I need a DEL for storage/ warehousing activities?

Warehousing / storage are not licensable activities. However these sites must follow proper Good Manufacturing Practices (GMPs) and may be subject to an inspection. Please refer to GUI-0069 Guidelines for Temperature Control of Drug Products during Storage and Transportation available on the Health Canada website for full details.

13. Do I need to notify Health Canada of a change in the third-party contracted to provide storage/warehousing activities?

Although warehousing and storage are not licensable activities, they may be subject to an inspection. You must therefore notify the Establishment Licensing, Billing and Invoicing unit of each warehouse/ storage location used to store drugs. These locations must be identified under Part C of the FRM-0033. They will be listed on the Warehouse Annex of the DEL.

14. In what instance would secondary packaging not require a DEL?

Primary packaging is the activity of putting a drug in its primary container which is in direct contact with the drug. The outer container is called secondary packaging. The activity of secondary packaging does not require a DEL if it does not include any labelling information. For example, assembling multiple products with a see-through packaging material that has no additional labelling information does not require a DEL.

15. In what instance would secondary packaging require a DEL?

Affixing a new label to an already labelled container to fulfill the regulatory requirements of Part C of the Food and Drug Regulations requires a DEL.

16. I conduct activities related to antimicrobial products. Do I need a DEL?

A DEL is not required for activities related to antimicrobial agents intended for use on:

  1. environmental hard surfaces; for example disinfectants that are used to clean work surfaces such as desks/benches, and
  2. non-invasive medical devices that are intended to come into contact with intact skin only; for example disinfectants used to clean a stethoscope.

Refer to GUI-0049 Standard for the Fabrication, Control and Distribution of Antimicrobial Agents for Use on Environmental Surfaces and Certain Medical Devices for standards that apply to the fabrication, control and distribution of antimicrobial agents for use on environmental surfaces and certain medical devices.

A DEL is required for activities related to other antimicrobial agents, including the following:

  1. Antimicrobial agents used for contact lenses which are required to be sterile;
  2. High level antimicrobial agents used to sterilize invasive devices or devices used for circulation and reintroduction of a body fluid;
  3. Antimicrobial agents used for devices to be introduced in a body cavity or that come in contact with a body fluid; and
  4. Antimicrobial agents with a valid DIN (including OTC products) used for sanitization of skin surfaces.

17. Do I need a DEL to export?

Exporting a drug product is a sale in Canada and therefore requires a DEL for the relevant activities.

Submitting a DEL Application

18. Following the amendment of the Regulations, when I am required to apply for a DEL relative to API licensable activities?

Current DEL holder conducting API related activities and  establishments conducting API activities, who currently do not hold a DEL, prior to the Coming into Force of the amended Regulations are required to apply for a DEL starting November 8th, 2013 and prior to February 8th, 2014.

Note: As long as a complete application is submitted prior to February 8th, 2014, you may continue to conduct API activities until otherwise advised by Health Canada.

New establishments proposing to start API activities are required to apply for a DEL anytime on or after November 8th, 2013. However, the applicants cannot commence the activities until the establishment has been inspected and deemed compliant.

19. Following the amendment of the Regulations, what can I expect during the submission process?

A) I am an API Fabricator, Packager/Labeller and Tester in Canada and do not have a DEL.

  1. Complete the following in form FRM-0033:
    • Tables 1,2,3 and 5,
    • Part A,
    • Sections 1, 2, 3.1, and 4.1 of Part B 
  2. You are not required to complete Table A and Section 5.1 as you are not importing APIs.
  3. An inspection will be conducted - Only a compliant rating will result in a DEL.

B) I am an API Importer in Canada and do not have a DEL.

  1. Complete the following in form FRM-0033:
    • Tables 1,2,3 and 5
    • Part A
    • Sections 1, 2, 3.1 of Part B
    • Section 5.1 and Table A
  2. An inspection will be conducted - Only a compliant rating will result in a DEL.
  3. API Foreign buildings will be listed on the annex of your licence.

C) I am a finished dosage form Fabricator in Canada that imports APIs for use in the manufacturing of my own products and I have a DEL.

You must amend your DEL to add the activity of API importation by completing the following in form FRM-0033

  • Tables 1,2,3 and 5
  • Part A
  • Sections 1, 2, 3.1 of Part B
  • Section 5.1 and Table A

Note: An inspection will be conducted and only a compliant rating will result in a DEL. API Foreign buildings will be listed on the annex of your licence.

D) I am a finished dosage form importer and I have a DEL.

You must amend your DEL to register the API foreign buildings by only complete section 5.1 including Table A of FRM-0033.

Note: The normal inspection cycle is not impacted (no new inspection is required). Foreign buildings will not be listed on the annex of your licence with the exceptions of:

  1. Non sterile API testers
  2. Sterile API Fabricators, packagers/labellers and testers

20. I currently have sterile API fabricators packagers/labellers, testers and/or non sterile API testers on my DEL. Do I need to submit information to Health Canada after the coming into force?

If the above information has not changed, no further action for your licence is required at this time.

If any of the above information has changed, you must amend your DEL using only Section 5.1 and Table A. Applicable GMP evidence must be submitted as per GUI-0080. Once the appropriate assessment is completed, the DEL and foreign building annex will be amended accordingly. If adding a new building, the building must be on listed on the foreign building annex before importation can commence.

21. What is a Foreign Building Information Table?

The Foreign Building Information Table (Table A in Section 5.1 of FRM-033) is a standardized table where you will list all foreign buildings that conduct licensable activities in regards to APIs. The table is to be submitted in Excel format only with the DEL application.

22. How do I apply for a DEL?

To apply for a DEL please follow the steps below:

  1. Inform yourself of the regulatory requirements by reading the recommended guidance documents listed below.
  2. Verify that you are ready for an inspection of all domestic buildings proposed to conduct licensable activities. Refer to the guidance document GUI-0001 Good Manufacturing Practices Guidelines. For importation, wholesale, and distribution also refer to the Drug Establishment Good Manufacturing Practices - Drug Establishment Good Manufacturing Practices - Pre-Application Package (Importers, Distributors and Wholesalers).
  3. Complete form FRM-0033 Drug Establishment Licence Application: Forms and Instructions as well as the checklist for documents to be included upon submission.

Send completed forms, along with applicable documents and fees to: ELapplicationLE@hc-sc.gc.ca

Recommended References and Guidance Documents:

These documents, along with other helpful information, are also available on Health Canada Web site at: Establishment Licensing.

23. When do I need to submit my GMP information?

When submitting GMP information concerning the fabrication, packaging/labelling and testing of sterile/non-Sterile Finished Dosage Forms and sterile APIs including the non-sterile testing of APIs consider the following:

  • If the GMP evidence for a foreign building listed on your DEL is expiring, send the updated GMP information at least 250 calendar days in advance of its expiration date to amend the foreign building annex of your DEL. Include a completed section 5.0 and/or 5.1 of the FRM-0033 for each foreign building.
  • If submitting an application to amend your DEL to add a new foreign building, the GMP information must accompany the application.

Note: If the foreign building is located in a country that has a Mutual Recognition Agreement (MRA) with Canada and the activities are covered therein, you do not require to submit the GMP information; however, you are still required to apply for the amendment. Health Canada will request the GMP evidence from the applicable Regulatory Authorities once the application (section 5.0 and/or 5.1 of FRM-0033) has been received.

When submitting GMP information concerning the fabrication and packaging/labelling of non-sterile APIs, consider the following:

The submission of GMP evidence is currently not required for non-sterile API foreign fabricators, packagers / labellers . At this time, applicants are required to submit an attestation and a completed API Foreign Information Table (Section 5.1 and Table A of form FRM-0033). Health Canada will use this attestation as evidence of GMP compliance. In addition, all GMP evidence must be readily available within 48 hours upon request by Health Canada.

Submit GMP information to:

ELapplicationLE@hc-sc.gc.ca

24. How do I amend my DEL?

When applying for an amendment please submit the following documentation:

  1. FRM-0033, Completed and signed. If the amendment is to only add one or more foreign buildings, completing section 5.0/Section 5.1 of the FRM-0033 to provide the new information is sufficient.
  2. If applicable, all relevant Foreign building GMP information (Refer GUI-0080 Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites)
  3. Applicable Fees
  4. Other applicable documents, as outlined in FRM-0033.

Send to: ELapplicationLE@hc-sc.gc.ca

The Licensing Process

25. What can I expect during the licensing process?

Applications are acknowledged usually within 2 weeks of the receipt. If an application is not acknowledged after 2 weeks, contact ELapplicationLE@hc-sc.gc.ca to ensure it was received.

Health Canada will communicate with the contact person on the application if there is information missing or other deficiencies are identified. Timelines and expectations will be clearly indicated in the requests. Ensure that your contact information is always up to date. We mostly communicate by email, telephone and/or fax.

26. When can I expect my application to be processed?

The average service standard is 250 calendar days from the day the application is received by Health Canada's Establishment Licensing Billing and Invoicing Unit. Depending on the application type, completeness and/or complexity of the activities performed and the number of drug products, the processing time may vary. We expect APIs to be subject to a similar time frame.

27. When can I expect my establishment to be inspected?

For inspections related to Finished Dosage Forms, Health Canada aims to schedule inspections of new establishments within 90 days of receiving the complete application.

For inspections related to APIs, Health Canada will provide more information shortly.

28. Will there be a reminder or package sent out for Annual Reviews?

Although Health Canada aims to provide Annual Review Application packages to all valid DEL holders, it remains the responsibility of the DEL holder to submit their Annual Review Applications before April 1st of each year in order to continue to perform the activities. If you have not received the package by January 1st, please contact DEL_questions_LEPPP@hc-sc.gc.ca.

29. When is the earliest that we can submit our application for Annual Review?

You can submit your application at any time between April 1st and March 31st of the following year. However, for administrative efficiency, we encourage that you wait for the renewal package to be received before you proceed with the renewal application. Please contact us if you have not received your renewal package by January 1st.

30. How will I know when the process is complete and I will receive a licence?

When an application is processed and completed, an updated DEL will be sent by mail and/or email to the establishment. For the list of active DEL holders, visit DEL holders listing.

31. I am a new applicant and received my first DEL. Do I need to submit an application for Annual Review the same calendar year?

No. You will need to submit an application for your first Annual Review before April 1st the calendar year after the year your first licence was issued.

For example, if you received your new DEL with an issue date between January 1st and December 31st of 2013, you will be required to submit your first Annual Review application prior to April 01, 2014. If you received your new DEL with an issue date of January 1st, 2014 or later; you will be required to submit your first Annual Review application prior to April 1st, 2015.

32. What happens if I submit my Annual Review application on April 1st or later?

If an application for Annual Review is not submitted to reach Health Canada before April 1st of each year, the licence is automatically cancelled as per the Food and Drug Regulations. In this case, the DEL holder must cease all licensable activities. An application for re-instatement, along with the applicable fees, must be submitted and a new licence issued before resuming activities.

33. Will I receive a revised licence once an amendment application is processed?

Yes. You will receive a revised licence if the change affects the information that is shown on the licence.

34. Will I be re-inspected after a move?

An inspection may be required. We will contact you to schedule an inspection, if necessary.

35. Under what circumstances would a DEL application be refused?

  1. The following list illustrates some examples where a DEL application would be refused:
  2. The establishment is not ready for their scheduled GMP inspection
  3. The establishment underwent a GMP inspection, but is found non-compliant
  4. The application requirements are not met (including incomplete applications)
  5. The applicant voluntary withdraws their application
  6. The applicant makes false or misleading statement(s) to Health Canada

Please note that if you do not hold a valid DEL, you are not allowed to conduct licensable activities.

DEL Holder obligations

36. Will my DEL expire?

Effective April 1, 2011, an establishment licence will no longer expire on December 31 of each year. Your licence will continue to be valid as long as a complete application for Annual Review is submitted before April 1st of each year.

37. What is the deadline for submitting an Annual Review Application?

DEL holders must submit a complete Annual Review application before April 1st of each year. If an application is not received, the DEL is cancelled on April 1st.

38. If there are no changes to my licence by April 1st of a given year, do I still have to submit an application for Annual Review?

Yes. An Annual Review application must be filed each year to allow Health Canada to assess continued compliance with the Food and Drug Regulations.

39. My company changed names. Do I need to provide evidence of the name change?

You are required to notify Health Canada within 15 days after the change via a cover letter on company letter head. Health Canada requests that you provide the government-issued business registration number/document for the new name along with the appropriate sections completed in FRM-0033.

40. What change of information requires an amendment to a DEL?

Common examples of amendments to a DEL include:

  1. Change to dosage form sterility
  2. Addition/ removal of dosage forms
  3. Addition/ removal of product categories
  4. Change to company name or address
  5. Change to contact information
  6. An event which may have impacted the quality, safety or efficacy of a drug
  7. Sale of a company
  8. Merger of companies
  9. Addition or removal of licensable activities
  10. Addition or removal of a domestic building
  11. Addition or removal of a foreign building

41. Should I notify Health Canada if I add new DIN products to my product line?

Yes. An up-to-date listing of your DIN products should be provided when you submit your Annual Review package. If a new DIN requires the addition of a new category/dosage form to your DEL, an amendment to your DEL is required and an inspection may also be needed.

42. If the company name has changed, are we a new company?

Determination of a new company depends on a variety of factors and is made on a case-by-case basis. You may be subject to an inspection and you may be issued a new DEL# depending on your scenario. Please contact the Establishment Licensing, Billing and Invoicing Unit (ELBIU) at DEL_questions_LEPPP@hc-sc.gc.ca.

43. If we are moving, what do we do?

You must submit an application (FRM-0033) to amend your licence at least 250 days prior to the start of licensable activities at the new location. The new location may be subject to inspection. For additional details, refer to the question "How do I amend my DEL?"

44. I bought company A and the leftover stock. Can I sell the products under my licence with company A's label?

In situations like these, recommendations are made on a case by case basis. The Inspectorate considers various factors such as (but not limited to) risk levels of products, the quantity of stocks etc. before a decision is made. Please contact Health Canada at DEL_questions_LEPPP@hc-sc.gc.ca explaining the situation and an officer will assist you.

45. My establishment is no longer conducting licensable activities. What is the process for voluntarily cancelling a DEL?

In order to cancel a licence, please send a request to cancel the licence via FRM-0033 signed by the licensee to the Establishment Licensing, Billing and Invoicing Unit (ELBIU) at ElapplicationLE@hc-sc.gc.ca.

Note: A DIN owner cannot cancel their DEL if they have any active (marketed) DINs.

46. Under what other circumstances would a DEL be cancelled?

Other circumstances where a DEL may be cancelled include:

  1. Health Canada does not receive an Annual Review Application before April 1st.
  2. The establishment's DEL has been suspended by Health Canada for a year or more.

47. When is a DEL suspended by Health Canada?

The following are some examples of when Health Canada may suspend a DEL:

  1. A GMP inspection that results in a non-compliant rating.
  2. Health Canada has deemed that the suspension of a DEL will prevent harm to the health and safety of Canadians.
  3. The licensee has made false or misleading statement(s) to Health Canada.

General Questions

48. Where do I find information on DEL Holders?

Information on active Drug Establishment Licence (DEL) holders is available on the Health Canada Website. The DELs listing allows active licensees to be identified either by DEL number, company name, activities and/ or province, or by any terms and conditions associated with the licence.

49. I have read GUI-0002 and these FAQs, but still have questions. Who should I contact?

  1. For general enquiries related to a DEL application, please contact: DEL_questions_LEPPP@hc-sc.gc.ca
  2. For fee related enquiries, please contact: ELIU_UFLE@hc-sc.gc.ca
  3. For API-related enquiries, please contact: API_questions_IPA@hc-sc.gc.ca
  4. For Foreign Building GMP enquiries, please contact: Foreign_site_etranger@hc-sc.gc.ca

Additional information can be found on the Establishment Licences Website.

General Questions - Fees

50. Why is there a fee for a DEL?

The fees associated with a DEL cover a portion of the cost of Health Canada's regulatory programs for drugs. It covers the cost of review of an application for establishment licensing, conducting inspections for good manufacturing practices and security inspections, and conducting drug analysis.

51. What is the fee for a new DEL or the Annual Review of an existing DEL?

The fees charged are the same for the examination of an application for a DEL or for the Annual Review of a DEL. The fee is an annual charge, and is the sum of two components, each designed to reflect the cost of the activity required for:

  1. Assessment of application - is the sum of fee for assessing the activities, categories of drugs and dosage form classes, foreign sites, and additional dosage form classes per foreign site. The fee is designed to accommodate the different types of firms subject to the licensing framework. A GMP inspection is conducted to ensure that drugs are fabricated, packaged, labelled, imported, distributed, wholesaled and tested in a manner consistent with the Food and Drug Regulations.
  2. Drug analysis - is a fee that is proportional to the cost of product analysis for different drug categories averaged across all firms dealing in that category of drug. Different product classes (e.g. vaccines, prescription drugs) are charged differential fees in recognition of the relative risk of these products and the resulting frequency of laboratory surveillance. The drug/ laboratory analysis is a supplement to inspections, and provides evidence of the effectiveness of a firm's controls, particularly in relation to the quality control department.

For more information on fees for Human Drug / Human and Veterinary Drug DELs, please see sections 19 to 25 of the Fees in Respect of Drugs and Medical Devices Regulations. Every fee set out in the Regulations is to be increased annually by 2%, rounded up to the nearest dollar, beginning on April 1, 2012. This does not apply to fees when only veterinary drugs are involved.

For more information on fees for Veterinary Drug Only DELs, please see sections 4 to 10 of the Next link will take you to another Web site Establishment Licensing Fees (Veterinary Drug) Regulations.
Please visit our website or contact the Establishment Licensing, Billing and Invoicing Unit at ELIU_UFLE@hc-sc.gc.ca for instructions on how to determine the fee for your DEL.

52. Is anyone exempted from fees?

DEL applicants that fall within any of the following 3 categories are not required to pay DEL fees:

  1. any publicly funded health care facility
  2. any branch or agency of the Government of Canada or the government of a province
  3. any establishment who conducts licensable activities solely for APIs

Dealer's Licence applicants that fall within any of the following three categories are not required to pay Dealer's Licence fees: (1) any publicly funded health care facility or (2) any branch or agency of the Government of Canada or the government of a province or (3) any person or organization engaged only in scientific activities.

53. I am a new applicant. Do I need to pay when applying?

If you are a new applicant your fee is automatically deferred for one full calendar year.

A 'new applicant' is one who has not completed their first full calendar year of conducting activities under a DEL. An applicant whose licence was cancelled and who was issued a new DEL number is not considered a new establishment.

Human Drug / Human and Veterinary Drug:

Payment of the applicable fee is deferred until the end of the first full calendar year of conducting activities under a DEL.

Example:
If an applicant who has never previously held a DEL submits and is issued their DEL on any day in 2013, fee payment is deferred until the final business day of December 2014.

Veterinary Drug Only:

Under the old Fee Regulations, the payment of the applicable DEL fee is deferred until within 90 days after the day on which that first calendar year ends.

Example:
If an applicant who has never previously held a DEL submits and is issued a DEL on any day in 2013, fee payment is deferred until 90 days of the final business day of that year (March 31, 2015).

54. I am applying for an Annual Review. When / where do I pay my fees?

Payment and fee remission request (if applicable) is due with the Annual Review application. Please see question 18 on how to submit an application.

55. Is there a fee for an amendment?

Only amendments to add the following to a DEL are subject to fees:

  1. an upstream activity
  2. an additional category
  3. a new domestic building
  4. sterile dosage form for the first time at a building (for Fabricators only)

56. Do I have to pay for a reinstated licence?

Yes. If your licence was suspended, withdrawn or cancelled, you are required to pay for an application to reinstate the licence. The applicable fee is the same as the fee for a new DEL or Annual Review application.

57. If I am issued a new licence part way through the year, do I still have to pay the full fee?

Yes. You are required to pay the full fee as the fee is not prorated.

58. Will I be reimbursed if I withdraw my application for a DEL or if my licence is cancelled?

No. The fee remains payable and will not be reimbursed. The fee is for the review of an application; therefore, if an applicant chooses to withdraw an application or if the licence is cancelled, Health Canada will not credit or refund any of the fees paid by the applicant as these fees cover the cost of review of the application.

59. Can I be exempted from paying an invoice?

If fees are applicable, you cannot be exempted from payment of the fees. Health Canada will not credit or refund any of the fees paid by the establishment. Please see question 62.

Fee Remission

60. What is a fee remission?

The fee for the review of an application for a DEL can be reduced to a percentage (see question 65) of an establishment's annual gross revenue generated from activities conducted under the licence. A fee remission request be must be supported by a Certified Statement of Revenue and must accompany the DEL application for the request to be reviewed and considered by Health Canada.

61. Am I eligible for a fee remission?

Human Drug / Human and Veterinary Drug:

You are eligible for a fee remission if the fee payable is greater than 1% of your actual gross revenue (AGR) generated from activities under the licence.

If a DEL holder also holds a Dealer Licence issued by the Healthy Environments and Consumer Safety Branch (HECSB), the remission is calculated based on the sum of the fee for a DEL and Dealer Licence.

Example:
If the total fee payable by an applicant, according to the schedules set out in the regulation, is $16,075 and the applicant's annual gross revenue equals $500,000, then the reduced fee is $5,000.

Veterinary Drug Only:

You are eligible for fee remission if the fee payable is greater than 1.5% of your actual gross revenue generated from the activities under the licence.

If a DEL holder also holds a Dealer Licence, the remission is calculated based on the sum of the fee for a DEL and Dealer Licence.

Example:
If the total fee payable by an applicant, according to the schedules set out in the regulation, is $16,075 and the applicant's annual gross revenue equals $500,000, the reduced fee is 7,500.

62. Do I need to apply for a fee remission every year?

Yes. If you wish to avail of the a fee remission, you must submit your request every year as part of the Annual Review application and your request must be supported with a Certified Statement of Revenue showing your annual gross revenue from the previous year.

63. How do I apply for a fee remission?

To request a fee remission, your application must include the following:

  • A completed application form
  • A Certified Statement of Revenue signed by the delegated signing authority responsible for your financial affairs that sets out the annual gross revenue generated from the activities conducted under your DEL.
  • Payment for the reduced amount

To facilitate the review process, we encourage you to submit a calculation chart with your application.

64. I am a new company. How do I apply for a fee remission?

A 'new company' is one that has not completed its first full calendar year of conducting activities under a DEL. A company whose licence was cancelled and who was issued a new number is not considered a new company.

If you are a new company applying for a DEL, your fee is deferred until the end of your first full calendar year of activities under the licence (Human Drug / Human and Veterinary Drug) or within 90 days after the day on which that first calendar year ends (Veterinary Drug Only). Health Canada will contact applicants advising them of the requirements to pay their fee and submit a fee remission request, if applicable. Applicants will have 30 days to respond and submit the appropriate payment along with a fee remission request, if applicable.

To facilitate the review process, we encourage you to submit a calculation chart with your application.

65. What is a Certified Statement of Revenue?

A Certified Statement of Revenue is a statement signed by the individual responsible for your company's financial affairs that sets out the annual gross revenue generated from the activities conducted under your DEL.

Health Canada does not provide a form or template for this requirement. It is the applicant's responsibility to provide a document that outlines the annual gross revenue. As examples, the Certified Statement can be a signed letter on company letterhead, a signed copy of the applicant's general ledger or a signed copy of sales logs from the general ledger. The statement must clearly demonstrate the annual gross revenue from the sales under the DEL from the last completed calendar year. For example, if the Certified Statement of Revenue is submitted to Health Canada in February 2014, it must show the revenue from sales between January 1, 2013 and December 31, 2013.

66. What revenue should I use when calculating my annual gross revenue for activities conducted under my DEL?

The annual gross revenue is the amount earned by an establishment during a calendar year from activities for which an DEL was required. This includes revenue for the export of drugs, except those for which section 37 of the Food and Drugs Act has been invoked.

67. How will I know if my fee remission request is approved?

Only applicants who do not qualify for a fee remission will be notified as to why their fee remission is denied and the resulting fee that is due.

68. What is the Calculation Chart?

The Calculation Chart is a tool that Health Canada uses to help determine the total fee and the potential fee remission for a DEL. To facilitate the review process, we encourage you to submit a calculation chart with your application.

69. Can Health Canada ask for an audited statement?

Yes.  Health Canada can ask for an audited statement. If the information supplied in support of a fee remission request is deemed inadequate to determine your actual gross revenue, Health Canada may require the applicant to provide sales records audited by a qualified independent auditor. The audited records will be used to determine the fee payable and you will be required to bear the cost of the independent audit.

Payment of Fees

70. What methods are available for the payment of fees?

For instruction on the payment of fees, please see our guide on How to Pay Fees.

71. Do I have to pay interest on an overdue account?

Yes, you have to pay interest on an overdue account. If full payment is not received within 30 days of the invoice date, interest will accrue. You will receive monthly statements until the debt is cleared.

Interest will not be waived once it is accrued. The fee plus any accrued interest must be paid.

72. What happens if my account is in arrears? Will it be sent to a collection agency?

If Health Canada is unable to recover the outstanding balance on your account, the account may be turned over to a collection agency.

73. If my account is in arrears, what are my options to pay off my debt?

Health Canada is committed to working with applicants whose accounts are in arrears, and encourages them to contact Accounts Receivable at 1-800-815-0506, (613) 957-1052, or via email at AR-CR@HC-SC.GC.CA as soon as possible to work out a monthly payment arrangement.

74. What is a payment arrangement?

A payment arrangement is an agreement between the applicant and Health Canada to recover the amount due to the Receiver General for Canada for a DEL. Repayment schedules allow fixed monthly payments by the client, repaying the debt in the shortest period of time possible. The establishment of a repayment schedule will mean that the account is not sent to a collection agency, provided the client repays according to the terms and conditions established with the agreement.

75. What is the interest rate on the money I owe to Health Canada for a licence in arrears?

Currently, the interest rate is equal to the Bank of Canada rate +3%. It is up to the client to verify interest rates, if and when applicable.

76. What can I do if I don't agree with the calculation of my fees?

If you do not agree with the calculation of your fees, you may file a request to reconsider. Please submit your request to:

Email: ELIU_UFLE@hc-sc.gc.ca

or
Establishment Licensing, Billing and Invoicing Unit
Compliance Coordination and Licensing Division
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Graham Spry Building - 2nd Floor
Address Locator 2002C
Ottawa, ON K1A 0K9
or
Fax: 613-957-4147

77. What happens in the case of an overpayment?

Overpayment of fees will be automatically credited to account. A written request is required for refund of a credit balance. In addition, you may request that we apply your credit balance to payment / partial payment of advance fees. In this case, please attach to the submission / application a copy of the most recent statement indicating the account or client number / amount of available credit.

For further instruction on how to submit payment, see our guide on How to Pay Fees.

78. Important dates and deadlines for DELs and fees

Example: If first DEL was issued February 1st, 2012 (Human Drug / Human and Veterinary Drug DELs)
Year Annual Review Fee Due Fee Remission Request

This table applies to any new establishment who is issued their first licence any time during 2013.

For new establishments, the fee is deferred until the end of their first full calendar year of activities under the licence. In this example, the first full calendar year of activities is 2014. Health Canada will contact establishments who have completed their first calendar year of activities advising them of the requirements to pay their fee and submit a fee remission request, if applicable.

2013 Not required Fee Deferred until Dec. 31, 2014 Fee Deferred until Dec. 31, 2014
2014 Before April 1st, 2014 Fee Deferred until Dec. 31, 2014 Fee Deferred until Dec. 31, 2014
2015 Before April 1st, 2015 At time of application With application
On-going Before April 1st each year At time of application With application
Example: If first DEL was issued February 1st, 2013 (Veterinary Drug Only DELs)
Year Annual Review Fee Due Fee Remission Request

This table applies to any new establishment who is issued their first licence any time during 2013.

For new establishments, the fee is deferred until 90 days after the end of their first full calendar year of activities under the licence. In this example, the first full calendar year of activities is 2014. Health Canada will contact establishments who have completed their first calendar year of activities advising them of the requirements to pay their fee and submit a fee remission request, if applicable.

2013 Not required Fee Deferred until 90 days after Dec. 31, 2014 Fee Deferred until 90 days after Dec. 31, 2014
2014 Before April 1st, 2014 Fee Deferred until 90 days after Dec. 31, 2014 Fee Deferred until 90 days after Dec. 31, 2014
2015 Before April 1st, 2015 At time of application With application
On-going Before April 1st each year At time of application With application

79. Who should I contact if I have further questions?

  1. for general enquiries related to a DEL application, please contact: DEL_questions_LEPPP@hc-sc.gc.ca
  2. For fee related enquiries, please contact: ELIU_UFLE@hc-sc.gc.ca

Additional information can be found on the Establishment Licences website.