Drug establishment licence application: forms  and instructions (FRM-0033)

Drug establishment licence application form

Table of Contents

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Information: Supplementary information that could be helpful

When to use this form

If you fabricate, package/label, import, distribute, wholesale or test human and/or veterinary drugs, you must apply for and maintain a Drug Establishment Licence (DEL).

Use this application form to:

  • apply for your first DEL
  • submit changes to an existing DEL
    • contact information
    • activities, categories and dosage forms of drugs
    • sterile fabrication of a dosage form
    • establishment name and/or address of the building
    • Alternate Sample Retention (ASR) site
  • request reinstatement if your DEL been suspended by Health Canada
  • request that your DEL be cancelled
  • request reactivation of a previously cancelled DEL

Important message for small businesses: Companies looking to apply for the small business fee mitigation must visit the Funding and Fees web page at https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees.html and formally apply as a small business prior to submitting this application. If your application is received and your company is not registered as a small business, the full fee will be charged and you will not be considered for the small business fee mitigation.

Instructions

The following tables outline what you are requesting as part of the application.

Table 1. Drug Establishment Licence (DEL) information (existing DEL Holders only)

[Drug Establishment Licence (DEL) number] is completed by those whom already possess a Drug Establishment Licence (DEL) number. If your DEL has been suspended or cancelled, please include the DEL number to facilitate tracking.

Table 2. Application type

Select all the appropriate application types.

[New application] is completed by a company who does not hold a valid DEL and is applying for a DEL.

[Amendment] is completed by any DEL holder desiring to make an amendment(s) to an existing DEL.

Table 3 must be completed if the application includes amendments.

[Canadian warehouse] is completed by any company desiring to store drugs (Active Pharmaceutical Ingredient (API) and/or Finished Dosage Form (FDF)) at any Canadian location (Part C of the form).

[Alternate sample retention site application] is completed by any company desiring an Alternate Sample Retention Site (Part D of the form).

[Request cancellation] is completed by any DEL holder desiring to cease all licensable activities and cancel their DEL. Please fill in the Drug Establishment Licence number and the date you will cease licensable activities.

[Request re-instatement] is completed by any DEL holder who has had their DEL suspended by the Minister and desires to request the reinstatement of their DEL.

[Request re-activation] is completed by an applicant that wishes to re-apply for a previously cancelled DEL.

Table 3. Summary of amendment type(s)

Select all amendment types and actions (add, remove or modify) that apply for this application. Selected actions imply that there are changes to be made to the selected section.

Table 4. Fee information and attachments

[Small business mitigation] refers to a 25% reduction in the fee payable for any business, including its affiliates, that has fewer than 100 employees, or generated between $30,000 and $5 million (CAD) in annual gross revenues. Please refer to guidance on Fees for the Review of Human and Veterinary Drug Establishment Licence Applications at https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-drug-establishment-licence.html for more information.

In the event that a company has not yet completed a full fiscal year, it is permissible to use estimates/projections with respect to annual gross revenue and number of employees. In this situation Health Canada will follow-up once the applicant’s fiscal year end date has passed to verify the company’s small business status.

[Publicly funded health care institutions or government organizations] All applications filed by publicly funded health care institutions, or any branch or agency of the Government of Canada or of a province or territory, are exempt from fees. Please refer to the Fees for the Review of Human and Veterinary Drug Establishment Licence Applications for more information.

[DEL calculation chart] is used as an aid in the calculation of DEL fees.  Always provide a copy of the Calculation Chart with the application.

In order to obtain a copy of the Drug Establishment Licence Fee Calculation Chart, please contact the Cost Recovery Invoicing Unit at hc.criu-ufrc.sc@canada.ca.

Table 5. Other attachments

[Cover Letter for this application] is a letter submitted on company letter head containing supplemental information not captured by this form.

[GMP evidence to support the addition/renewal of foreign buildings] is submitted to support the addition/renewal of every foreign building. Required Good Manufacturing Practices (GMP) evidence is outlined in Part B, Section 5.0 of the application form.

[Table A] a complete Table A must be submitted in addition to FRM-0033, when submitting an application pertaining to:

  • amend the Active Pharmaceutical Ingredient (API) Foreign Building Annex to your DEL or
  • add an API Foreign Building Annex to your DEL or
  • add an API Foreign Building Annex as part of a new DEL application

The most recent version of Table A can be requested from the DELUnithc.del.questions-leppp.sc@canada.ca. It can be accessed from the automated bounce back you receive when sending an email to the above address.

Part A: Company information

This Part is to be completed by all companies.

[Company name] is the legal name of the company submitting the application.

[Drug establishment licence number] is completed by the Company who already possess a Drug Establishment Licence number.

[Is this company a DIN owner] please select if the company holds any Drug Identification Numbers (DIN).

[Drug class] please select if the drug is intended for Human and/or Veterinary use.

Company address is the physical location of the Head Office.

Mailing address is where paper correspondence and the licence are to be sent.

[Mailing contact] is the contact person that Health Canada will address mail to.

Billing address is where the invoice is to be sent.

[Billing contact] is the contact person that Health Canada will address invoices to.

Emergency contact information is the contact information that can be used to reach a company representative outside of regular office hours.

[Name of authorized signing official] is the individual who is responsible for the application.

Part B: Canadian building information

If a company conducts activities at more than one building, then Part B of the application must be completed for each building.

Section 1: Address information

This section refers to the physical location of the building(s) in Canada where licensable activities occur.

[Building name] is a name that a company uses to identify a building.

[Building no.] is a number that a company uses to identify a building.

[Dwelling house] indicate if the building in which licensable activities are occurring is a house.

[DEL # letter suffix] is the number and letter associated to the Drug Establishment Licence. This letter is only available for buildings already included on a DEL. For new buildings, leave this box blank.

Address information is the physical location of the building. This cannot be a post office box.

[Contact person] as outlined in in Management of Applications and Performance for Drug Establishment Licences GUI-0127 this is the person to whom Health Canada will send all communications regarding application deficiencies and pause-the-clock.

Section 2: Drug Good Manufacturing Practices (GMP) inspection information

Companies must indicate whether or not the building has been inspected by a Health Product Compliance Directorate (HPCD) drug GMP inspector. If the response is yes, indicate the date of the last inspection. Other types of inspections conducted by Health Canada personnel (for example, on-site evaluations by Biologics and Genetics Therapies Directorate for New Drug Submissions) are not considered equivalent to a drug GMP inspection. For more details, refer to POL-0011 GMP Inspection Policy for Canadian Drug Establishments.

Section 3.0: Domestic Finished Dosage Form (FDF) information

Only companies conducting licensable activities with regards to Finished Dosage Form products must complete this section.

This section refers to information regarding the activities, the categories, and the class of finished dosage form at the Canadian building (Part B: Section 1). For API related activities and the class of Final API Forms please refer to Part B: Section 3.1.

  • [Activity] When completing Section 3.0, indicate the number corresponding to the activity being performed at this Canadian building:
    • 1 = Fabricate
    • 2 = Package/Label 
    • 3 = Test
    • 4 = Import
    • 5 = Distribute
    • 6 = Wholesale

If the activity of import is selected, ensure that information on foreign buildings is provided using Sections 5.0 (FDF) and 5.1 (API).

  • [Category] When completing section 3.0, indicate the number corresponding to the category subject to licensable activities at this Canadian building:
    • 1 = Pharmaceutical
    • 2 = Vaccine
    • 3 = Biological
    • 4 = Radiopharmaceutical
    • 5 = Footnote 1 Prescription Drug List (PDL), Schedule G, Narcotics and/or   Footnote 2 Drug containing Cannabis (for wholesalers only)

Please enter only one category per line.

[Class of finished dosage form] The appropriate class of finished dosage form must be completed for each drug associated with the entry. The dosage form class must be the same as the dosage form authorized by Health Canada as part of the drug market authorization. To identify the dosage form associated with a drug, refer to the Online Drug Product Database (DPD).

Ensure that an “S” is indicated for each class of finished dosage form utilizing sterile production techniques. An example is provided on the application form.

Sterile (S) must be listed on the application form beside the Class of Finished Dosage Form for all buildings where the fabrication, packaging/labelling, testing, importation, distribution and wholesaling is associated with sterile drug products.

Section 3.1: Domestic Active Pharmaceutical Ingredient (API) information

Only companies conducting licensable activities with regards to Active Pharmaceutical Ingredients (API) products must complete this section.

This section refers to information regarding the activities, and the class of API at the Canadian building (Part B: Section 1).

  • [Activity] When completing Section 3.1, indicate the number corresponding to the activity:

Enter only one activity per line.

  • 1 = Fabricate
  • [Manufacturing process] Select a manufacturing process only if the activity of Fabricate is selected. Indicate next to the number 1 the letter associated to the manufacturing used. For example, if you perform chemical synthesis, enter 1a. For multiple processes, simply add the corresponding letters (for example, 1ac).
  • Manufacturing processes
    1. Chemical Synthesis
    2. Extraction
    3. Cell Culture/Fermentation
    4. Isolation/Recovery from natural sources
    5. Other (specify)
  • 2 = Package/Label
  • 3 = Test
  • [Testing process] Select a testing process only if the activity of test is selected. Indicate next to the number 3 the letter associated to the testing used. For example, if you perform chemical testing, enter 3a. For multiple processes, simply add the corresponding letters (For example, 3bc).
  • Testing processes
    1. Chemical
    2. Microbial
    3. Sterility
    4. Other (specify)
  • 4= Import

[Category] When completing section 3.1, indicate the number corresponding to the category subject to licensable activities at this Canadian building:

Enter only one Category per line

  • 1 = Active Pharmaceutical Ingredients (API)
  • 2 = List A API for Veterinary Use (Active pharmaceutical ingredients set out in List A that are for veterinary use)

[Drug class] Select the drug class – Product for Human or Veterinary use.

[Class of final API forms] The appropriate class of final API form must be completed for each entry.

The sterilization of Active Pharmaceutical Ingredients is considered a step in the manufacturing of the finished dosage form pharmaceuticals and should be entered under Section 3.0.

Section 4.0: Domestic Finished Dosage Form (FDF) product information

Only companies conducting licensable activities with regards to Finished Dosage Form products must complete this section.

For the section related to Active Pharmaceutical Ingredients that the company fabricates, packages/labels at the Canadian building, refer to Part B: Section 4.1.

Section 4.0 applies to:

  • all narcotic and Controlled drugs for all activities, except import, conducted by the company
  • other drugs fabricated, packaged/labelled by the company.

Section 4.0 does not apply to imported drugs as this information is to be provided in Part B of Section 5.0.

[Product name] is the name under which the product is sold.

[Drug class] Select the drug class – Product for Human or Veterinary use.

[Schedule/PDL] Indicate the schedule or Prescription Drug List (PDL) Footnote 1 to which the drug belongs (for example schedule D for biologicals). This information can be found at Online Drug Product Database (DPD) at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp.

[Drug Identification Number (DIN)] is an eight digit number assigned to a drug product. It must be included unless not required by regulation (for example, active ingredients).

[Activity] For narcotics and controlled drugs, select all activity that applies. For other drugs, select only Fabricate or Package/Label as applicable.

Section 4.1: Domestic Active Pharmaceutical Ingredient (API) information

Section 4.1 contains information only about the API that the company fabricates and packages/labels at the address outlined in Part B: Section 1. 

Section 4.1 does not apply to the companies:

  • Engaged solely in testing or wholesaling; and
  • Importing API products, as this information will be captured in Table A of Section 5.1 under API product information.

[API name] is the name of the active ingredient that is used in the fabrication of a pharmaceutical.

[Associated Drug Identification Number (DIN)] is the eight digit drug identification number of the Finished Dosage Form drug product which the API will be used to fabricate.

[Activity] For each API, select all activities that apply to it [fabricate (F) and package/Label (P/L)].

Section 5.0: Finished Dosage Form (FDF) foreign building information

Complete Section 5.0 only if the foreign building is conducting any licensable activities related to Finished Dosage Form products.

Foreign company name and building address information

  • [Foreign company name] is the legal name of the foreign company which is engaged in licensable activities; not necessarily the DIN owner.
  • [Foreign building name] is a name that a company uses to identify a foreign building.
  • Foreign building address is the physical location of the foreign company at which the licensable activity is being conducted.
  • [Building in an MRA country] is selected if the foreign building is located in a Mutual Recognition Agreement (MRA) country.
  • [Are activities covered by MRA?] is selected if all the licensable activities conducted at this foreign building are covered under the Mutual Recognition Agreement.
    • Note: If the answer to both questions [Building in an MRA country], and [Are activities covered by MRA], is yes then the [Required GMP documents] section do not require to be completed.
  • Reason for submission select the reason(s) for submission that apply from the available predetermined list.
    • [Renew (NERBY)] select if the foreign building is currently on your DEL and would like to update the GMP New Evidence Required By (NERBY) date.
    • [Add] select if you would like to add a new foreign building that is currently not on your DEL.
    • [Amend] select if you would like to make an amendment(s) to an existing foreign building listed on your DEL or remove Terms and Conditions.
    • [Remove] select if you would like to remove an existing foreign building that is currently on your DEL.

Licenced importers may apply to amend their Foreign Building Annex by completing only Section 5.0 of the DEL Application Form, for each fabricator, packager/labeller, and/or tester. A cover letter from the importer describing the amendment requested should accompany the Section 5.0(s).

Canadian building information is completed when Section 5.0 is submitted separately as part of an amendment or when the contact is unique for the foreign building.

  • [Canadian company name] is the legal name of the Canadian company importing from this foreign building.
  • [Drug establishment licence number] is the DEL number of the importer. Only companies who possess a Drug Establishment Licence number are required to record this information.
  • [Contact person] is designated to receive feedback about the foreign building and is the person to whom foreign building correspondences will be sent.
  • [Name of authorized signing official] is the individual who is responsible for the application.

Activity, Category and Class of Dosage Form Class Information refers to information regarding the activities, the categories, and the class of finished dosage forms of the drug products at the indicated foreign building.

  • [Activity] is limited to fabricate, package/label and/or test. When completing Section 5.0, indicate the number corresponding to the activity being conducted at this foreign building:
    • 1 = Fabricate
    • 2 = Package/Label
    • 3 = Test
  • Testing process Please select a testing process only if the activity of test is selected. Please indicate next to the number 3 the letter associated to the testing used. For example, if you perform stability testing, enter 3g. For multiple processes, simply add the corresponding letters (For example, 3bce).
  • Testing processes:
    1. Biological
    2. Chemistry
    3. In-process
    4. Microbiological – Sterility
    5. Microbiological
    6. Physicochemical
    7. Stability
    8. Other (specify)
  • [Category] When completing Section 5.0, indicate the number corresponding to the category subject to licensable activities at this foreign building:

Please enter only ONE category per line.

  • 1 = Pharmaceutical
  • 2 = Vaccine
  • 3 = Biological
  • 4 = Radiopharmaceutical
  • 5 = Prescription Drug List (PDL),Footnote 1 Schedule G, Narcotics, and/or Footnote 2 Drug containing Cannabis (for wholesalers only)
  • [Class of Finished Dosage Form] The appropriate class of finished dosage form must be completed for each entry Please use the dosage form associated with the drug’s market authorisation issued by Health Canada available in the Drug Product Database online query.

Sterile (S) must be listed on the application form beside the class of Finished Dosage Form for all buildings where the fabrication, packaging/labelling, and testing is associated with sterile drug products.

Finished Dosage Form (FDF) product information section refers to information regarding the finished dosage form drug products handled at the indicated foreign building.

  • [Product name] is the name under which the product is sold.
  • [Drug class] Select the drug class – Product for Human or Veterinary use.
  • [Schedule/PDL] Indicate the Schedule or Prescription Drug List (PDL) Footnote 1 to which the drug belongs (for example Schedule D for biologicals). This information can be found at Online Drug Product Database (DPD).
  • [Drug Identification Number (DIN)] is the eight digit drug identification number assigned to a product. It must be included unless not required by regulation (for example, active ingredients).
  • [Activity] For each product, select all activities that apply to it [fabricate (F), package/label (P/L), and/or test (T)].

Required GMP evidence documents refers to all Good Manufacturing Practices evidence document required for applications that require a GMP evidence package.

Refer to GUI-0080 How to demonstrate foreign building compliance with drug good manufacturing practices for a list of required GMP evidence documents.

It is the importer’s responsibility to ensure that Health Canada receives a complete application along with all GMP evidence when applicable.

Section 5.1: Active pharmaceutical ingredients foreign building information

This section applies to importers of APIs and FDFs and needs to be completed when submitting an application to request an Active Pharmaceutical Ingredients Foreign Building Annex or to request an amendment to your Active Pharmaceutical Ingredients Foreign Building Annex .

Canadian building information is completed to confirm the attestation stated in Section 5.1. If left blank, the information submitted in Part B Section 1 will be used.

  • [Canadian company name] is the legal name of the Canadian company importing products into Canada.
  • [Drug establishment licence number] is only completed by the company who already possess a Drug Establishment Licence number.
  • [Contact person and title] the person who is designated to receive feedback about the foreign building and the person to whom API foreign building correspondences will be sent.

Attestation and undertaking

  • [Name of senior official] is the individual who is responsible for the application.
  • [Name of quality assurance official] is the individual who is responsible for Quality Assurance.
Table A: Foreign buildings conducting API-related licensable activities
  • Section 5.1. must be accompanied by the most recent version of the Table A form which can be requested from DEL Unit at hc.del.questions-leppp.sc@canada.ca. It can be accessed from the automated bounce back you receive when sending an email to the above address. Please refer to Table A for instructions on how to complete the form.

Section 5.2: Active pharmaceutical ingredients non-compliant foreign building information

Complete Section 5.2 only if the foreign building is currently rated as non-compliant by Health Canada and you are submitting GMP evidence for assessment by Health Canada.

A cover letter from the importer describing the actions should accompany the Section 5.2(s).

Foreign building name and address information

  • [Foreign company name] is the legal name of the foreign company that is engaged in licensable activities;
  • Foreign building address is the physical location of the foreign company at which the licensable activity is being conducted.

Activity, category and class of dosage form class information refers to information regarding the activities, the categories, and the class of Active Pharmaceutical Ingredients indicated at the foreign building.

  • [Activity] is limited to fabricate, package/label and/or test. When completing Section 5.2, indicate the number corresponding to the activity being conducted at this foreign building:
    • 1 = Fabricate
    • 2 = Package/Label
    • 3 = Test
  • [Category] Since Section 5.2 is only applicable to Active Pharmaceutical Ingredients the only option is to select No. 1 or No. 2:
    • 1 = Active Pharmaceutical Ingredients
    • 2 = List A API for Veterinary use (Active pharmaceutical ingredients set out in List A that are for veterinary use)
  • [Class of final API form] The appropriate class of Active Pharmaceutical Ingredients must be completed for each entry. The three classes of Active Pharmaceutical Ingredients have been coded 1-3. When completing Section 5.2, indicate the number corresponding to the class of Active Pharmaceutical Ingredients.

The sterilization of Active Pharmaceutical Ingredients is considered a step in the manufacturing of the finished dosage form pharmaceuticals and should be entered under Section 5.0.

Part C: Canadian warehouse information

Complete Part C only if applying for a Canadian storage facility for FDF and/or API that is not already recorded in Part B.

[Warehouse company name] is the name of the Canadian building where the FDF and/or API will be stored.

[Building name] is completed only if the name of the building differs from the name of the warehouse.

[Date of last drug GMP inspection] is the date of the most recent Health Canada drug GMP inspection conducted for the listed warehouse.

Building must be compliant with Division 2 Good Manufacturing Practices of the FDR.

If more warehouses need to be listed than the space provided, additional Part C: Canadian Warehouse Information pages must be used.

Complete Part D only if a foreign storage facility for FDF and/or API is being used as an alternate sample retention building.

[Building where samples are to be retained] refers to the foreign building name and address.

Building must be outside of Canada, and must be compliant with Division 2 of the FDR.

[Product name] The name of the product as it is associated to its Drug Identification Number (DIN).

[Drug Identification Number (DIN)] an eight digit DIN must be provided for each product listed.

More information on Alternate Sample Retention can be obtained from GUI-0014 Alternate Sample Retention Site Guidelines at https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/alternate-sample-retention-site-guidelines-0014.html.

Submitting the DEL application

In order for the DEL process to start, applications must be submitted using one of the methods outlined below.

Filing by email:

hc.el.applications-le.sc@canada.ca.

Filing by mail
Drug Establishment Licensing Unit
Jeanne Mance Building
200 Eglantine Driveway
Address Locator #1913B
Ottawa, Ontario
K1A 0K9

Filing by fax
1 (613) 957-4147

For more information
Please send your inquiries to DEL Question at hc.del.questions-leppp.sc@canada.ca.

Footnotes

Footnote 1

Came into force December 19, 2013 (Repeal of Schedule F)

Return to footnote 1 referrer

Footnote 2

Came into force October 17th, 2018

Return to footnote 2 referrer

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