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Drug Establishment Licence application form (FRM-0033)

FRM-0033 instructions

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Application Information

Table 1. Drug establishment licence information (existing DEL holders only)

Drug Establishment Licence (DEL) # (if applicable):

Table 2. Application type (select the one type that applies)

Table 3. Summary of amendment type(s) (select all that apply)

Add or Remove or Modify

Part A: Company information:

Part B: Canadian building information:

Section 1
Building name:
Address information:
Contact information:

Section 3.0/3.1
Activity:
Category:
Drug Class:
Class:

Section 4.0/4.1
Product information:
Foreign building information:

Section 5.0/5.1
Company name:
Building name:
Address information:
Activity:
Category:
Class:
Product information:

Part C: Canadian warehouse:
Part D: Alternate sample retention site:

Table 4. Fee information and attachments (select all that apply)

Small business mitigation:

Option 1 (both boxes must be selected):

We certify that we meet the definition of a small business at the time of this filing and have applied for small business status for our company with Health Canada and have received confirmation prior to submitting this submission/application.

We understand that failure to hold a valid small business status with Health Canada at the time of submitting this submission/application will result in the full fee being charged.

Option 2:

I am not applying for the small business mitigation.

Important: If left blank, or if option 2 is selected, the full fee will be charged and you will not be considered for the small business mitigation.

Fee exemption

I certify that I meet the definition of a Publicly Funded Health Care Institution.

I certify that I am a branch or agency of the Government of Canada or of a province or territory.

See section 3 of the Fees in Respect of Drugs and Medical Devices Order for more details at https://laws-lois.justice.gc.ca/eng/regulations/SOR-2019-124/FullText.html.

DEL calculation chart

I have attached the completed DEL calculation chart.

Table 5. Other attachments (select all that apply)

Part A: Company information

Company name:
DEL # (if applicable):
Is this establishment a DIN owner? Yes or No
Drug class: Human or Human and veterinary or Veterinary only

Company address
Building name or number (if applicable):
Street:
Suite and/or P.O. box:
City:
Province:
Postal code:
Contact person and title:
Language: English or French
Telephone:
Fax:
Email:

Mailing address: or same as establishment address
Company name (if different from establishment name):
Street:
Suite and/or P.O. box:
City:
Province:
Postal code:
Mailing contact and title:
Language: English or French
Telephone:
Fax:
Email:

Billing address: or same as establishment address or same as mailing address
Company name (if different from establishment name):
Street:
Suite and/or P.O. box:
City:
Province:
Postal code:
Billing contact and title:
Language: English or French
Telephone:
Fax:
Email:

Emergency contact information (At all times or outside business hours)
Contact person and title:
Language: English or French
Telephone:
Fax:
Email:

Signature of signing authority
Name of authorized signing official:
Title:
Telephone:
Fax:
Email:
Signature:
Date (yyyy-mm-dd):

Part B: Canadian building information

Section 1: Address information: same as establishment address or same as mailing address or same as billing address

Building name or number (if applicable):
Dwelling-house: Yes or No
DEL # and letter (if applicable):
Street:
Suite or P.O. box:
City:
Province:
Postal code:
Contact Person:
Language: English or French
Title:
Email:
Telephone:
Fax:

Section 2: Drug GMP inspection information

Has this building undergone a drug GMP inspection by a Health Canada inspector: Yes or No

Date of last drug GMP inspection (yyyy-mm-dd):

Section 3.0: Domestic finished dosage form (FDF) class information

Enter only one category per line. Enter all that apply. (S) is used to indicate sterile dosage.

e.g. Activity: 1, 2 Category: 1 Class of FDF: Solution-S, powder-S, tablet, capsule, API-S

Activity:

Category:

  1. Came into force December 19, 2013 (Repeal of Schedule F)
  2. Came into force October 17th, 2018

Class of FDF:

Please use the dosage form associated with the drug's market authorisation issued by Health Canada available in the Drug Product Database online query at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp. If the dosage form is an active pharmaceutical ingredient (API), bulk process intermediate (BPI) or packaging material, please indicate API, BPI or packaging material below.

Section 3.1: Domestic API information

Enter only one activity per line.

e.g. Activity 4 Category: 1 Drug class: Human = Yes / Veterinary = No Class of final API forms = 1, 2

Activity:

Category:

Drug Class:

Class of final API forms:

  1. The sterilization of API should be entered in section 3 under the activity fabricate and the drug category Pharmaceutical, dosage form API (solid, liquid or gas).
  2. Active pharmaceutical ingredients set out in List A that are for veterinary use.
  3. Drug for human use
  4. Drug for veterinary use

Section 4.0: Domestic FDF class product information

Product name:
Drug class: H1 V2
Schedule / PDL3:
DIN4:
Activity 5: F P/L T6 D6 W6

  1. Drug for human use
  2. Drug for veterinary use
  3. Drug category listed in Table 2 of section C.01A.008 of the Food and Drug Regulations
  4. Drug Identification Number
  5. F=Fabricate, P/L=Package/Label, T=Test, D=Distribute, W=Wholesale
  6. For the activity of test, distribute and wholesale, it is only required to provide drug information for drugs that are narcotics as defined in the Narcotic Control Regulations or controlled drugs as defined in subsection G.01.001(1) or each drug containing cannabis as defined in subsection 2(1) of the Cannabis Act

Section 4.1: Domestic API information (complete only if applying to fabricate and package/label)

API name:
Associated (DIN):
Activity: F1 P/L1

  1. F=Fabricate, P/L=Package/Label

Section 5.0: FDF foreign building information

Foreign company name and building address information

Foreign company name:
Foreign building name:
Street:
City:
Province/State:
Country:
Postal code/ZIP code:
Building in a Mutual Recognition Agreement (MRA) country? Yes or No
Are activities covered by an MRA? Yes or No
Reason for submission: Renew Add Remove Amend

Canadian building information (complete only if submitting Section 5 separately)

Canadian company name:
Drug establishment licence number (10XXXX-X/3-00XXXX-X):
Contact person and title:
Telephone:
Fax:
Email:
Name of authorized signing official:
Title:
Signature:
Date (yyyy-mm-dd):

Activity, Category and Dosage Form Class Information

Enter only one category per line. (S) is used to indicate sterile dosage form.
e.g. Activity: 1, 3a,3b Category: 1 Class of FDF: Solution-S, powder-S, tablet, capsule, API-S

Activity:

Category:

Class of FDF:

Please use the FDF associated with the drug's market authorisation issued by Health Canada available in the Drug Product Database online query at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp. If the dosage form is an active pharmaceutical ingredient (API), bulk process intermediate (BPI) or packaging material, please indicate API, BPI or packaging material below.

FDF product information (Complete only if applying for: fabricate, package/label and/or test)

Product name:
Drug class: H1 V2
Schedule / PDL3:
DIN4:
Activity: F5 P/L5 T5

  1. Drug for human use
  2. Drug for veterinary use
  3. Drug category listed in Table 2 of section C.01A.008 of the Food and Drug Regulations
  4. Drug Identification Number
  5. F=Fabricate, P/L=Package/Label, T=Test

Required GMP evidence documents (select and complete all that apply)

The final and most recent (within the last 3 years) inspection report signed issued by:

The corrective actions taken, signed by a responsible official of the foreign building (if applicable)
A copy of the Site Master File, or a similar document such as a quality manual
A Letter of Authorization (LoA) to reference a GMP evidence package from a previously submitted application

Section 5.1: API foreign building information

Canadian building information (complete only if submitting Section 5.1 separately)

Canadian company name:
Drug establishment licence number (10XXXX-X/3-00XXXX-X):
Contact person and title:
Phone:
Fax:
Email:

Attestation and undertaking
I <name> attest to the following statements:

  1. I have signing authority for <DEL applicant/company name> and am the contact person with respect to this application and any subsequent related matters that may arise.
  2. All the information about the foreign buildings presented in this application is up to date, accurate and complete.
  3. The records regarding the quality of the active pharmaceutical ingredient in support of Table A are maintained on my premises at <address>.

I understand that Health Canada may at any time request and/or inspect the records relevant to determining the foreign building's compliance with the applicable Good Manufacturing Practices (GMP) requirements, notwithstanding the fact that I am not required to provide them to Health Canada at this time as part of this application. I undertake to provide any requested records in one of the two official languages of Canada (English or French) within 48 hours of receiving the request from Health Canada in writing. In the event that a situation arises where the health and safety of Canadians is potentially at risk, I undertake to make every reasonable effort to provide them to Health Canada on an expedited basis.

I further undertake to notify Health Canada if an event occurs at any foreign building that could affect the quality, safety or efficacy of an active pharmaceutical ingredient.

Name of authorized signing official:
Title of authorized signing official:
Signature of authorized signing official:
Date (yyyy-mm-dd):
Name of quality assurance official:
Title of quality assurance official:
Signature of quality assurance official:
Date (yyyy-mm-dd):

Foreign buildings conducting API-related licensable activities

A Table A must be submitted with your FRM-0033.

Note: (1) If Table A is not completed, the application will be treated as incomplete. Submit Table A along with FRM-0033 electronically.

(2) Applications that do not include the most recent version of Table A (available from DELU at del.questions-leppp@hc-sc.gc.ca) will be treated as incomplete.

SECTION 5.2 API - non-compliant foreign building information

Foreign building name and address information

Foreign company name:
Street:
City:
Province/State:
Country:
Postal code/ZIP code:

Activity, category and dosage form class information

Enter only one category per line.

e.g. Activity: 1,2 Category: 1 Class of Final API Form: 1,2

Activity:

Category:

Class of Final API Form:

Part C: Canadian Warehouse Information

Warehouse company name:
Building name (if applicable):
Date of last drug GMP inspection (yyyy-mm-dd):
This warehouse is used for storage of products from DEL # (10XXXX-X/3-00XXXX-X):
Street Address:
Suite and/or P.O. box:
City:
Province:
Postal code:
Contact person and title:
Language: English or French
Phone:
Fax:
Email:

Part D: Alternate sample retention site application

Building where samples are to be retained (Company name & address):
Product name:
DIN:

Privacy notice

The personal information you provide to Health Canada will be used by the Drug Establishment Licencing regimen, under the authority of the Food and Drugs Act, section 23(1)(c) and handled in accordance with the Privacy Act.

Why are we collecting your personal information? The personal information is used to support Health Canada's compliance and enforcement activities, including inspections and investigations, related to human or veterinary drugs.

Will we use or share your personal information for any other reason? In limited and specific situations, your personal information may be shared internally or with other regulators through international agreements, without your consent in accordance with subsection 8(2) of the Privacy Act.

What are your rights?You have the right to access and request a correction and/or notation to your personal information. You also have a right to complain to the Privacy Commissioner of Canada if you feel your personal information has been handled improperly. For more information about these rights, or about how we handle your personal information, please contact the Health Canada's Privacy Management Division at 613-948-1219 or privacy-vie.privee@hc-sc.gc.ca.

For more information: The collection of your personal information is described in Info Source at https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/access-information-privacy/info-source-federal-government-employee-information.html. Refer to the personal information bank (PIB) for these collections are described in HC PPU 407 Compliance and Enforcement Pharmaceutical Drugs and HC PPU 408 Compliance and Enforcement - Biologics & Radiopharmaceuticals.

Pub.: 190598

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