- 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
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/content/canadasite/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 DEL number. If your DEL has been suspended or cancelled, please include the DEL number to facilitate tracking.
Table 2. Application type
Select the appropriate application type.
[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/content/canadasite/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 DEL Fee Calculation Chart, please contact the Cost Recovery Invoicing Unit at criu-ufrc@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 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 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 DEL Unit: del.questions-leppp@hc-sc.gc.ca.
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.
[DEL 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
[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 # and letter] is the number and letter associated to the DEL. 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) at https://www.canada.ca/content/canadasite/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/management-applications-performance-drug-establishment-licences-0127.html, 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 Biologic and Radiopharmaceutical Drugs Directorate for New Drug Submissions) are not considered equivalent to a drug GMP inspection. For more details, refer to GMP Inspection Policy for Canadian Drug Establishments (POL-0011) at https://www.canada.ca/content/canadasite/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/inspection-policy-canadian-drug-establishments.html.
Section 3.0: Domestic Finished Dosage Form (FDF) information
Only companies conducting licensable activities with regards to FDF products must complete this section.
This section refers to information regarding the activities, the categories, and the classes of FDFs at the Canadian building (Part B: Section 1). For API related activities and the classes 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 = (for Wholesalers only) = 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 FDF] The appropriate class of FDF 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) at https://www.canada.ca/content/canadasite/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html. If the dosage form is an active pharmaceutical ingredient (API), bulk process intermediate (BPI) or packaging material, please indicate API, BPI or packaging material.
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 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
- Chemical Synthesis
- Extraction
- Cell Culture/Fermentation
- Isolation/Recovery from natural sources
- 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
- Chemical
- Microbial
- Sterility
- 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 located here https://www.canada.ca/content/canadasite/en/public-health/services/antibiotic-antimicrobial-resistance/animals/veterinary-antimicrobial-sales-reporting/list-a.html, 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 API 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 FDF product information
Only companies conducting licensable activities with regards to FDF products must complete this section. For the section related to API that the company fabricates, packages/labels at the Canadian building, refer to Part B: Section 4.1.
Section 4.0 applies to:
- all narcotic, controlled drugs and drugs containing cannabis 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)* to which the drug belongs (for example schedule D for biologicals). This information can be found at the online Drug Product Database (DPD) at https://www.canada.ca/content/canadasite/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html.
*Came into force on December 19, 2013 (Repeal of Schedule F)
[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, controlled drugs, and drugs containing cannabis, select all activities that apply. For other drugs, select only Fabricate or Package/Label as applicable.
Section 4.1: Domestic 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 DIN] is the eight digit drug identification number of the FDF 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: FDF foreign building information
Complete Section 5.0 only if the foreign building is conducting any licensable activities related to FDF 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 a Mutual Recognition Agreement (MRA) country] is selected if the foreign building is located in an MRA country.
- [Are activities covered by MRA?] is selected if all the licensable activities conducted at this foreign building are covered under the MRA.
- If the answer to both questions [Building in an MRA country], and [Are activities covered by MRA], is yes then the Required GMP documents table of Section 5.0 is not required 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 you 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.
- [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.
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 DEL 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 FDF 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
- Biological
- Chemistry
- In-process
- Microbiological
- Microbiological - Sterility
- Physicochemical
- Stability
- Other (specify)
Please enter only one category per line.
- 1 = Pharmaceutical
- 2 = Vaccine
- 3 = Biological
- 4 = Radiopharmaceutical
- [Class of FDF] The appropriate class of finished dosage form must be completed for each entry. Please use the dosage form associated with the drug's market authorization issued by Health Canada available in the Drug Product Database online query at https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html. If the dosage form is an active pharmaceutical ingredient (API), bulk process intermediate (BPI) or packaging material, please indicate API, BPI or packaging material.
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.
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).
- [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 How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) at https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guidance-evidence-demonstrate-drug-compliance-foreign-sites-0080.html 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: API foreign building information
This section applies to importers of API and FDF and needs to be completed when submitting an application to request an API Foreign Building Annex or to request an amendment to your API 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 authorized signing 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 the DEL Unit at del.questions-leppp@hc-sc.gc.ca. Please refer to Table A for instructions on how to complete the form.
Section 5.2: API 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 classes of API 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
- 1 = Active Pharmaceutical Ingredients
- 2 = List A API for Veterinary use (Active pharmaceutical ingredients set out in List A that are for veterinary use)
The sterilization of APIs 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 Food and Drug Regulations.
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
Complete Part D only if a foreign storage facility for FDF and/or API is being used as an alternate sample retention building. Additionally, please submit Appendix A of the Guidance Document Alternate Sample Retention Site Guidelines (GUI-0014) available at https://www.canada.ca/content/canadasite/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/alternate-sample-retention-site-guidelines-0014.html#appa.
[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 Good Manufacturing Practices of the Food and Drug Regulations.
[Product name] The name of the product as it is associated to its Drug Identification Number (DIN).
[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/content/canadasite/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:
Filing by mail
Drug Establishment Licensing Unit
Jeanne Mance Building
200 Eglantine Driveway
Address Locator #1913B
Ottawa, Ontario
K1A 0K9For more information
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Footnotes
Footnote 1Came into force December 19, 2013 (Repeal of Schedule F)
Came into force October 17 th , 2018
