Drug Establishment Licence Application: Forms and Instructions (FRM-0033)

Table of Contents

Instructions

Table 1. Drug Establishment Licence (DEL) Information (Existing DEL Holders Only)

[Drug Establishment Licence Number (DEL)] 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.

[Application Tracking Number] is for Health Canada use only.

Table 2. Application Type

Note: Select all the appropriate application types. If the application is directed towards Active Pharmaceutical Ingredients and/or Finished Dosage Forms please select one/both options, respectively.

[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.

  • Note: Table 3 must be completed if the application includes amendments.

[Canadian Warehouse] is completed by any company desiring to store drugs (API and/or FDF) at any Canadian location (Part C).

[Alternate Sample Retention Site Application] is completed by any company desiring an Alternate Sample Retention Site (Part D).

[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 wish to cease licensable activity.

[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.

Table 3. Summary of Amendment Type(s)

Note: 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.

[Company Information] is the location of the company Head Office (Part A).

[Canadian Building Information] refers to the physical location of the building(s) in Canada where licensable activities occur (Part B).

  • Section 1
    • [Building Name] is a name which a company uses to identify a building.
    • [Address Information] is the physical location of the building.
    • [Contact Information] is the responsible individual at the Canadian building.
  • Section 3.0 and 3.1
    • [Activity] refers to licensable activities outlined in Part B, Section 3.0 and 3.1.
    • [Category] refers to the category of drugs outlined in Part B, Section 3.0 and 3.1.
    • [Drug Class] refers to APIs for use in humans or veterinary drugs, Section 3.1 only
    • [Class] refers to the class of Finished Dosage Form (FDF) and class of Final Active Pharmaceutical Ingredient (API) Form outlined in Part B, Section 3.0 and 3.1.
  • Section 4.0 and 4.1
    • [Product information] refers to drugs (FDF and/or API) that the company fabricates, packages/labels and/or distributes (Part B, Section 4.0 and 4.1)

[Foreign Building Information] refers to the physical location of the building(s) outside of Canada where licensable activities occur (Part B, Section 5.0 and 5.1).

  • Section 5.0 and 5.1
    • [Foreign Company Name] is the legal name of the foreign company which is engaged in licensable activities; not necessarily the DIN owner.
    •  [Building Name] is a name which a company uses to identify a building.
    • [Address Information] is the physical location of the building.
    • [Activity] refers to licensable activities outlined in Part B, Section 5.0 and Table A in Section 5.1.
    • [Category] refers to the category of drugs outlined in Part B, Section 5.0 only.
    • [Class] refers to the class of FDF and class of API outlined in Part B, Section 5.0 and Table A in Section 5.1.
    • [Product information] refers to drugs (API and/or FDF) that the company fabricates and packages/labels and testing outlined in Part B, Section 5.0 and Table A in Section 5.1.

[Canadian Warehouse] refers to any Canadian location used by a company to store drugs (API and/or FDF).

[Alternate Sample Retention Site] refers to any foreign location used by a company to store drugs (API and/or FDF).

Table 4. Fee Information and Attachments (Finished Dosage Form Only)

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

[Fee Deferral] refers to a process developed to assist in supporting small and medium-sized businesses in the deferral of the regulatory fee in support of an application until the completion of their first calendar year. Please refer to GUI-0002 Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees for Fee Deferral qualifications.

[Request Fee Remission] refers to a process developed to assist in supporting small and medium-sized businesses in the reduction of the regulatory fee in support of an application. Please refer to GUI-0002 Guidance on Drug Establishment Licences and Drug Establishment Licensing FeesGUI-0002 for Fee Deferral qualifications.

[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, together with any applicable fees.

In order to obtain a copy of the Drug Establishment Licence Fee Calculation Chart, please contact the Cost Recovery Invoicing Unit at ELIU_UFLE@hc-sc.gc.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 GMP evidence is outlined in Part B, Section 5.0.

[Table A] is submitted along with Section 5.1. Table A is used to list all Foreign Buildings conducting licensable activities related to API.

The most recent version of Table A can be requested from DELU at hc.del.questions-leppp.sc@canada.ca

Part A: Company Information

Note: 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 correspondence and the licence is to be sent.

[Billing Address] is where the invoice is to be sent.

  • Note: the Billing Address is to be completed by all companies dealing with Finished Dosage Form drugs.  Companies dealing with only APIs are not required to provide a billing address.

[Contact Person] is the responsible individual at the Canadian building.

[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 which a company uses to identify a building.

[Building No.] is a number which 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 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] is the responsible individual at the Canadian building.

Section 2: Drug Good Manufacturing Practices (GMP) Inspection Information

Companies must indicate whether or not the building has been drug GMP inspected by a Health Product Compliance Directorate (HPCD)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

Note: 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
  • Note: If the activity of import is selected, ensure that information on foreign buildings are 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 1Prescription Drug List (PDL) & Schedule G, Narcotic (for wholesalers only)

    Footnotes

    Footnote 1

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

    Return to footnote 1 referrer

    Note: 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.

Note: 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

Note: 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:

    Note: 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:

    Note: 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.

    Note: 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

    Note: 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 as part 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 * to which the drug belongs (for example schedule D for biologicals). This information can be found at Online Drug Product Database (DPD).

    Footnotes

    Footnote 1

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

    Return to footnote 1 referrer

    [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

    Note: Only companies conducting licensable activities with regards to API must complete this section.

    Section 4.1 contains information only about the API that the company fabricates and packages/labels (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.

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

    [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

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

    Adding foreign Building:

    • New importers

      If applying for the activity of import (Section 3.0), please complete a Section 5.0 for each foreign fabricator, packager/labeller, and/or tester from which the product(s) will be imported into Canada.

    • Licensed importers

      Licensed importers may amend foreign buildings 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 actions should accompany the Section 5.0(s).

    Foreign Building Name and 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 which 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] 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.
      • [Remove] select if you would like to remove an existing foreign building that is currently on your DEL.
      • [DIN Submission] select if in support of any drug submission. If the addition of the foreign building is also desired, please select the add option.

    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.

    • [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:

      Note: Enter only one Category per line

      • 1 = Pharmaceutical
      • 2 = Vaccine
      • 3 = Biological
      • 4 = Radiopharmaceutical
      • 5 = Prescription Drug List (PDL)Footnote * & Schedule G, Narcotic (for wholesalers only)

      Footnotes

      Footnote 1

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

      Return to footnote * referrer

      [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.

      Note: 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 * to which the drug belongs (for example Schedule D for biologicals). This information can be found at Online Drug Product Database (DPD).
    • [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)].

    Footnotes

    Footnote 1

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

    Return to footnote * referrer

    [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.

    Note: 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

    Note: This section applies to importers importing APIs from a foreign building. In addition, this section is also used by the importers of Finished Dosage Forms, to list their foreign API Fabricators, Packagers/Labellers, and Testers, who supply Finished Dosage Form Foreign buildings.

    Adding Foreign Buildings:

    • New importers

      If applying for the activity of import (Section 3.0 and/or 3.1), complete Table A of the DEL Application form for each foreign fabricator, packager/labeller and tester from which the API products will be imported into Canada, and complete the Attestation set out in Section 5.1.

    • Licensed importers

      Licensed importers may amend foreign buildings by completing Table A of the DEL Application form for each foreign fabricator, packager/labeller, and/or tester they wish to list on their DEL, and complete the Attestation set out in Section 5.1. A cover letter from the importer describing the actions should accompany the Section 5.1(s).

Canadian Building Information is completed to confirm the attestation stated in Section 5.1.

  • [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]: is designated to receive feedback about the foreign building and is the person to whom 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 5.2: Active Pharmaceutical Ingredients Non-Compliant Foreign Building Information

Note: 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.

Adding API foreign Building:

  • 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 which is engaged in licensable activities;
  • [Foreign Building Address] is the physical location of the foreign company at which the licensable activity is being conducted.
  • [Reason for Submission]select the reason(s) for submission that apply from the available predetermined list.
    •  [Add] select if you would like to add a new foreign building that is currently assigned a non-compliant rating by Health Canada.

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 Finished Dosage 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.

    Note: 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.

Part C: Canadian Warehouse Information

Note: Complete Part C only if applying for a Canadian storage facility for FDF and/or API which 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.

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

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

Part D: Alternate Sample Retention Site Information

Note: 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.

Note: 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] 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 .

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