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

Contact Information

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To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Supersedes: 2003 Edition

Date issued: April 1, 2011

Date of implementation: April 1, 2011

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Introduction

A Drug Establishment Licence (DEL) is required for any person in Canada engaged in any of the six licensable activities with respect to drugs in dosage form and bulk intermediates of Schedule C (radiopharmaceutical) and Schedule D (biological) drugs. The six licensable activities are: fabricate, package/label, test, import, distribute and wholesale. For more information, please review the Guidance on Drug Establishment Licences (GUI-0002).

Important changes to DEL Application Process
Due to changes in the Food and Drugs Regulations, effective April 1 2011, an establishment licence will no longer expire on December 31 of each year. Application for Annual Review is due on April 1, of each year. Authorized foreign sites will continue to be assigned a GMP compliance expiry date which will appear on the foreign site annex of the licence. If applicable, terms and conditions on a DEL will continue to have expiration date.

Important changes regarding Fees

Payment for a drug establishment licence is due upon receipt of the application with the exception of establishments who have not completed their first calendar year of conducting licensable activities. Their payment is deferred for one calendar year. In order to apply for a fee remission, a completed Fee Form, a Certified Statement, and a DEL Calculation Chart must be submitted with the application. For more information on fees and fee remission, please refer to the following:

1. HPFB Inspectorate website
2. Section 10 of the Drug Establishment Licensing and Fee Guide
3. DEL Fee Form for calculating fee

Important Note: Money will not be refunded to applicants that are found not to require a DEL, not ready for first inspection, have received a non-compliant rating, or cancel their licence.

New Applications
New applications should be submitted once the establishment is ready to be inspected and to begin licensable activities. At this point in time, the applicant should also have received their Drug Identification Number (DIN) or is in the process of obtaining their DIN.

Note: A new building added to a preexisting licence will be treated as a new application.

Amendment Application
Amendments are to be submitted within 15 days of making the change or as part of the annual review process if the change is within 15 days of submitting the application for annual review. Amendments with respect to the establishment licence application are required to be submitted in order add or change any of the following:

• change of contact information,
• activities, categories and dosage forms of drugs,
• sterile fabrication of a dosage form,
• change of establishment name and/ or address of the building,
• change of Alternate Sample Retention Site.

Amendment to Change a Company Name
Companies may submit a letter on company letterhead detailing the name change. This is permitted when there are no operational or personnel changes. The letter must indicate that there are no operational or personnel changes and should be signed by the authorized signing official.

• Company Buy-Out/Merger
  Companies may submit a letter on company letterhead detailing the name change of the merged establishment. A new application form must be submitted for the newly merged company.
• Amendment to Add or Change a Foreign Site
  Changes to activities, categories, dosage forms or whether any drugs will be in a sterile dosage form at an existing foreign site, or a new foreign site on an importer's licence (see instructions for completing Section 5 for more information).

Instructions

This document contains instructions, important definitions, and key notes to assist applicants in the completion of their DEL Application. For convenience, the Alternate Sample Retention Site Application Form, the Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products Being Exported form, and the DEL Fee Form are included at end of the DEL Application Form.

Application Type

If applying for a new Drug Establishment Licence, select "New". If requesting an amendment to a previously issued Drug Establishment Licence, select "Amendment to Licence #" and specify the complete licence number (e.g. 100999-C).

Part A: Company Information

[Company Name] is the legal name of the company.
[Mailing Address] is where correspondence and the licence is to be sent.
[Billing Address] is where the fee statement is to be sent.

[Name of Authorized Signing Official] is the individual who is responsible for preparing the application

Note: A signature must be provided in order for the submitted DEL Application to be processed.

Part B: Canadian Building Information

If applicable, please indicate the DEL number on the provided line. If a company conducts activities at more than one building, then Part B of the application must be completed for each building.

Section 1: Location
This section refers to the physical location of the building(s) in Canada where licensable activities occur.

Building Identification

• [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] is a house where licensable activities are occurring.

[Address Information] is the address where the building is located, if it differs from the mailing or billing address. This cannot be a post office box.

• [Contact Person] is the individual at the Canadian building, who will be contacted regarding the inspection.

[Good Manufacturing Practices (GMP) Records Maintenance Address] is where the records required for compliance under Division 2 (GMP) of the Food and Drugs Regulations are maintained.

• [Contact Person] is the individual responsible to receive communication regarding the GMP Records Maintenance building

Section 2: GMP Inspection Information
Applicants are asked to indicate whether or not the building has been GMP inspected by a Regions and Programs Branch (RAPB) inspector. If the response is yes, please indicate the date of the last inspection. Other types of inspections conducted by Health Canada personnel (e.g. on-site evaluations by Biologics and Genetics Therapies Directorate for New Drug Submissions) are not considered equivalent to a GMP inspection. For more details, please refer to GMP Inspection Policy for Canadian Drug Establishments (POL-0011).

Section 3: Activity, Category and dosage form Class information
This section refers to information regarding the activities, the categories, and the dosage form classes of the drug products at the Canadian building (Part B: Section 1).

• [Activity] When completing Section 3, indicate the number corresponding to the activity:
  • 1 = Fabricate
  • 2 = Package/Label
  • 3 = Test
  • 4 = Import
  • 5 = Distribute
  • 6 = Wholesale
  
  
  
• [Category] When completing Section 3, indicate the number corresponding to the category:
  • 1 = Pharmaceutical
  • 2 = Vaccine
  • 3 = Blood & Blood Components
  • 4 = Biological
  • 5 = Radiopharmaceutical
  • 6 = Schedule F & G, Narcotic (for wholesalers only)
  
  
  
• Note: Please enter only one activity and one category per line.

[Dosage Form Classes] The appropriate dosage form box(es) must be completed for each entry. The possible dosage form classes have been coded 1-14. When completing Section 3, indicate the number corresponding to the dosage form class. For a listing of all the approved dosage form classes, please refer to the Drug Product Database (DPD) Online.

Code 14 applies to "other" dosage form classes. At the bottom of Section 3, there is an area to code these "other" dosage forms. For example, if you produce an implant and a dressing, enter A = Implant, B = Dressing and insert "A" and "B" in the appropriate fields/boxes in Column 14 of the table.

Please ensure that an "S" is indicated for each dosage form class utilizing sterile production techniques. An example is provided on the application form.

Note: Sterilization is considered the activity of fabrication. All buildings where the activities of fabrication, packaging/labelling, importation and distribution of sterile drug products must be listed on the application form. In addition, please ensure that third party companies who perform the activity of sterilizing packaging materials used in the preparation of aseptically filled sterile products do so in accordance with Division 1A, and Division 2 (section C.02.029).

Section 4: Product Information
This section contains information about the drugs that the applicant fabricates, packages/labels and/or distributes. This section is not applicable for the following establishments:

• those engaging solely in testing or wholesaling do not have to complete Section 4.
• those importers of finished products do not list such products in Section 4 since that information is captured in the product information in Section 5.

[Product Name] is the name under which the product is sold.
[Class] Select the drug class - Human or Veterinary.
[Schedule] Indicate the schedule to which the drug belongs (e.g. schedule D for biologicals). This information can be found at Drug Product Database (DPD) Online.
[DIN] is the drug identification number assigned to a product. It must be included unless not required by regulation (e.g., blood).
[Activity] For each product, select all activities that apply to it [fabricate (F), package (P), and/or distribute (D)].

Note: If additional space is needed to list product information, an attachment may be submitted with the application.

Section 5: Foreign Site Information

Adding foreign sites: new importers
If applying for the activity of import, please complete a Section 5 for each foreign fabricator, packager/labeller, and/or tester from which the product(s) will be imported into Canada.

Adding foreign sites: licensed importers
Licensed importers may add foreign sites by completing only Section 5 of the DEL Application Form, for each fabricator, packager/labeller, and/or tester they wish to add. A cover letter from the importer should accompany the Section 5(s).

[Foreign Site Name and Address Information]

• [Foreign Company Name] is the legal name of the foreign company which is engaging in a licensable activity; not necessarily the DIN owner.
• [Foreign Site Address] is the address of the foreign company at which the licensable activity is being conducted.

[Importer Information] is completed when Section 5 is submitted separately as part of an amendment or when the contact is unique for the foreign site.

• [Contact (foreign site correspondence)]: is designated to receive feedback about the foreign site and is the person to whom foreign site correspondence will be sent.

[Activity, Category and Dosage Form Class Information] refers to information regarding the activities, the categories, and the dosage form classes of the drug products at the indicated foreign site.

• [Activity] is limited to fabricate, package/label and/or test. When completing Section 5, indicate the number corresponding to the activity:
  
  
  • 1 = Fabricate
  • 2 = Package/Label
  • 3 = Test
    
    
• Note: Please enter only ONE activity and ONE category per line.

[Product Information]
This section refers to information regarding the drug products handled at the indicated foreign site.

• [Product Name] is the name under which the product is sold.
  [Class] Select the drug class - Human or Veterinary.
  [Schedule] Indicate the schedule to which the drug belongs (e.g. schedule D for biologicals).
  This information can be found at Drug Product Database (DPD) Online.
  [DIN] is the Drug Identification Number assigned to a product; to be included unless not required by regulation (e.g., blood).
  [Activity] For each product, select all activities that apply to it [fabricate (F), package (P), and/or test (T)].
• Note: If additional space is needed to list product information, an attachment may be submitted with the application.

Required Supplemental Documents for Foreign Site Submissions
Please refer to GUI-0080 - Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites for a list of required GMP documents. These documents are also required upon request for extension of GMP compliance expiry for existing foreign sites. Please note that if these documents are not provided in their entirety, the Drug GMP Inspections Unit will screen out the foreign site addition request.

Submit the completed Application Form(s) to:

Establishment Licence Invoicing Unit
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Graham Spry Building - 2^nd Floor
Address Locator 2002C
Ottawa, Ontario K1A 0K9

Useful Contact Information

For inquiries related to DELs:
Establishment Licence Unit (ELU)
Tel: 613-954-6790
Fax: 613-957-4147
Email: DEL_questions_LEPPP@hc-sc.gc.ca

For inquiries related to GMP inspections, foreign site submissions, Section 37, and alternate sample retention sites:
Drug GMP Inspections Unit
Tel: 613-957-1492
Fax: 613-957-6709
Email: GMP_questions_BPF@hc-sc.gc.ca
Email: foreign_site_etranger@hc-sc.gc.ca

For inquiries related to DEL fees:
Establishment Licence Invoicing Unit (ELIU)
Tel: 613-946-5141
Fax: 613-957-6711
Email: ELIU_UFLE@hc-sc.gc.ca

Checklist for DEL applicants

• DEL Application Form (completed and signed where applicable)
• Valid foreign site GMP Compliance Evidence (see GUI-0080 for more information)
• Alternate Sample Retention Site Application Form (if applicable)
• Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products Being Exported (if applicable)
• DEL Fee Form
• Fee Calculation (DEL Calculation Chart)
• Payment (if applicable)

Drug Establishment Licence Application Form

Application Type:

• New
• Amendment to licence #:

Part A: Company Information

Company Name:

Mailing Address:

• Street:
• Suite:
• Post Office Box:
• City:
• Province:
• Postal Code:
• Contact Person:
• Language: English or French
• Telephone:
• Fax:
• Email:

Billing Address: same as mailing address

• Street: Suite:
• Post Office Box:
• City:
• Province:
• Postal Code:
• Contact Person:
• Language: English or French
• Telephone:
• Fax:
• Email:

Name of Authorized Signing Official:
Title:
Signature:
Date (yyyy-mm-dd)

Part B: Canadian Building Information

Drug Establishment Licence # (if applicable):

Section 1: Location

• Building name:
• Building No:
• Dwelling house: Yes or No

Address Information: same as mailing address or same as billing address

• Street:
• Suite:
• City:
• Province:
• Postal Code:
• Contact Person:
• Language: English or French
• Telephone:
• Fax:
• Email:

GMP Records same as location address or same as billing address;
Maintenance Address:

• Street:
• Suite:
• City:
• Province:
• Postal Code:
• Contact Person:
• Language: English or French
• Telephone:
• Fax:
• Email:

Section 2: GMP Inspection Information
This building has undergone a GMP inspection by a Health Canada Inspector: Yes or No
Date of last GMP inspection (yyyy-mm-dd):

Section 3: Activity, Category and Dosage From Class Information

Activity

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

Category

• 1 = Pharmaceuticals
• 2 = Vaccine
• 3 = Blood & Blood Components
• 4 = Biological
• 5 = Radiopharmaceutical
• 6 = Schedule F & G, Narcotic (for Wholesalers only)

Dosage Form Class

• 1 = Powder for solution
• 2 = Tablet
• 3 = Capsule
• 4 = Solution
• 5 = Suspension
• 6 = Aerosol
• 7 = Powder
• 8 = Suppository
• 9 = Medical Gas
• 10 = Veterinary Premix
• 11 = Bulk Intermediates (biological only)
• 12 = Active Pharmaceutical Ingredient (API)
• 13 = Packaging Material
• 14 = Other^{Footnote 1}

Enter only one activity and one category per line
Note : An "S" should be placed in front of the "X" to indicate that the product is sterile

Section 4: Product Information (Complete only if applying for: fabricate, package/label and/or distribute)

• Product name:
• Class: Human or Vet
• Schedule:
• Drug Identification Number (DIN):
• Activity: F-P-D

Section 5: Foreign Site Information

Foreign Site Name and Address Information

• Foreign Company Name:
• Foreign Site Address:
• Street:
• Province/State:
• Country:
• Postal Code / Zip Code:

Importer Information (Complete only if Section 5 submitted separately)
Canadian Drug Establishment Name:

Drug Establishment Licence Number:
Contact (foreign site correspondence)

• Telephone:
• Fax:
• Email:

Name of Authorized Signing Official:
Signature:
Date (yyyy-mm-dd)

Activity Category and Dosage Form Class Information

Activity

• 1 = Fabricate
• 2 = Package/Label
• 3 = Test

Category

• 1 = Pharmaceuticals
• 2 = Vaccine
• 3 = Blood & Blood Components
• 4 = Biological
• 5 = Radiopharmaceutical
• 6 = Schedule F & G, Narcotic (for Wholesalers only)

Dosage Form Class

• 1 = Powder for solution
• 2 = Tablet
• 3 = Capsule
• 4 = Solution
• 5 = Suspension
• 6 = Aerosol
• 7 = Powder
• 8 = Suppository
• 9 = Medical Gas
• 10 = Veterinary Premix
• 11 = Bulk Intermediates (biological only)
• 12 = Active Pharmaceutical Ingredient (API)
• 13 = Packaging Material
• 14 = Other^{Footnote 2}

Enter only one activity and one category per line
Note : An "S" should be placed in front of the "X" to indicate that the product is sterile

Product Information

• Product name:
• Class: Human or Vet
• Schedule:
• Drug Identification Number (DIN):
• Activity: F-P-D

Alternate Sample Retention Site Application Form

^{Footnote *}Once completed, please fax this application form to the Health Products and Food Branch Inspectorate at 613-952-9805 or Email it to GMP_Questions_BPF@hc-sc.gc.ca.

1. Importer or Distributor

• Name:
• Address:
• Telephone number:
• Fax number:

2. Product

• Name:
• Din (if applicable):

3. Fabricator

• Name:
• Address:
• Telephone number:
• Fax number:

4. Site where samples are to be retained

• Name:
• Address:
• Telephone number:
• Fax number:

5. Criteria for assessment (complete as applicable)

1. The testing of this product requires specialized product-specific methodology that is not available in Canada: Yes or No If yes, please specify (e.g. unique bioassay involving the use of cell lines or animals):
2. This product is subject to Health Canada's lot release programme: Yes or No
3. Estimated Canadian utilization:
   1. Approximate number of lots sold annually in Canada:
   2. Approximate number of units sold annually in Canada:
      
4. Average batch size imported to Canada:
5. Approximate unit cost/value per sample:
6. Shelf life of perishable drug:
7. Radiopharmaceuticals: Yes or No
8. Non-prescription drug (see Category IV product monographs):
   • Acne therapies
   • Anti dandruff products
   • Antiperspirants
   • Antiseptic skin cleansers
   • Athletes foot treatments
   • Fluoride-containing anti-caries products
   • Medicated skin care products
   • Sunburn protectants
9. Hard surface disinfectants: Yes or No
10. The fabricator of the drug is located in Canada and is responsible for keeping the retained samples Yes (Complete section 4) or No

6. Attestation
We have formally arranged with the storage site to maintain sufficient numbers of samples of lots and retained as per storage conditions indicated on the label, with the same container-closure sold in Canada to allow access by all pertinent regulatory authorities including Health Canada. Yes or No

7. Commitment
We have a written commitment with the responsible person at the storage site that samples will be provided within48 hours of receiving a request from Health Canada.

• Signature, Responsible Officer:
• Title:
• Emergency Telephone Number:

Intention to Invoke Section 37 of the Canada Food and Drugs Act for Products being exported

Section 37 of the Food and Drugs Act states as follows:

"This Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word «Export» or «Exportation» and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner."

The Export Certificate that must accompany the packaged food, drug, cosmetic or device can be found on the Health Canada website on the Establishment Licensing page.

You are asked to inform us of the packages and contents of products that are exported in compliance with Section 37 of the Food and Drug Act at the time of Drug Establishment Licence renewal. This form must be used when you intend to invoke Section 37 for any drug products fabricated in Canada that you are to export. Please complete the following and return this document to the Health Products and Food Branch Inspectorate at fax 613-957-6709 or Email it to GMP_Questions_BPF@hc-sc.gc.ca.

Drug Establishment Licence Number:

Name of Establishment:

• The above establishment does not intend to invoke Section 37 for any products that they are exporting.
• As the above establishment intends to invoke Section 37 for exportation, I ensure that the Export Certificate has been duly signed by the Commissioner of Taking Oaths, that the Export Certificate is kept on the premises and covers the following products: (An attached list is acceptable.)

Please provide a copy of the duly signed Export Certificate for these packages.

• Product name
• DIN (if any)
• Dosage Form
• Strength
• Lot number
• Expiry date
• Sterile: Yes or No

If you intend to market the same products for consumption in Canada, please provide a statement of confirmation that the manufacturing of the packages for consumption in Canada meets all Good Manufacturing Practices.

Be advised that evidence of Good Manufacturing Practices compliance is required to rescind Section 37.

• Name of Regulatory Person:
• Signature of Regulatory Person:
• Date:

Drug Establishment Licence Fee Form

Company Name:

DEL#:

Mailing Address:

• Street:
• Suite:
• Post Office Box:
• City:
• Province:
• Postal Code:
• Contact Person:
• Language: English or French
• Telephone:
• Fax:
• Email:

Billing Address: same as mailing address

• Street:
• Suite:
• Post Office Box:
• City:
• Province:
• Postal Code:
• Contact Person:
• Language: English or French
• Telephone:
• Fax:
• Email:

Only for applicants who have not completed their first calendar year.

"I certify that I have not completed my first calendar year if conducting activities under an establishment licence."

Name of Authorized Signing Official:
Title:
Signature:
Date: (yyyy-mm-dd)

For all applicants

"I certify that the information given on this form and in any documents attached is correct, complete, and fully discloses the total Canadian revenue from the sales of products covered by the establishment licence"

Name of Authorized Signing Official:
Title:
Signature:
Date: (yyyy-mm-dd)