Drug Establishment Licence Application: Form and Instructions

This form is no longer valid and it has been replaced with Form -0033

(November 1, 2003)

Contact Name: Manager, Establishment Licence Unit
Tel: (613) 954-6790
Fax: (613) 957-4147
E-Mail: DEL_questions_LEPPP@hc-sc.gc.ca

Cover Page

OUR MANDATE:

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.

Health Products and Food Branch Inspectorate

Drug Establishment Licence Application: Form and Instructions

Supersedes:
October 22, 2001

Date issued:
November 1^st, 2003

Date of implementation:
November 1^st, 2003

Table of Contents

Introduction

Where to submit the application form(s)

Explanation of the Drug Establishment Licence Application Form

Part A: Company Information

Part B: Site Information

Section 1: Location

Section 2: GMP Inspection Information

Section 3: Activity, Category and Dosage Form Class Iinformation

Section 4: Product Information

Section 5: Foreign Site Information (required for importers only)

Category of Product and Dosage Form Class Information

Product information

Drug Establishment Licence Application Form

Part A: Company Information

Part B: Site Information

Section 1: Location

Section 2: GMP Inspection Information

Section 3: Activity, Category and Dosage Form Class Information

Section 4: Product Information

Section 5: Foreign Site Information

Category and Dosage Form Class Information

Product Information

Introduction

A Drug Establishment Licence is required for all businesses in Canada engaged in any of the six activities related to the manufacturing and testing of all drugs in dosage form and bulk intermediates of Schedule C (radiopharmaceutical) and D (biological) drugs. The six activities are: fabrication, packaging/labelling, importation, distribution, wholesale, and testing. Definitions of these activities can be found in the Food and Drug Regulations located on the Inspectorate website:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

A Drug Establishment Licence expires on December 31 of each year. Once a licence has been issued, a renewal package will be sent to companies to confirm that their company information is correct so that a new licence can be issued.

Companies are encouraged to consolidate all of their sites/buildings onto one licence. The sites must be under one management. The sites may be in different locations e.g., different cities and/or provinces.

A site is either a building located more than one kilometre from any other building of that establishment; or two or more buildings located within one kilometre of each other.

One licence number will be issued for each application (e.g., 100). Each site within an application will be further designated with a code (A, B, C....), e.g., 100-A.

Where to submit the application form(s)

Drug Establishment Licence applications will be received at and processed by the Establishment Licence Invoicing Unit (ELIU). Completed applications should be sent to:

Establishment Licence Invoicing Unit
Graham Spry Building, 2^nd Floor
PL 2002D
250 Lanark Avenue
Ottawa, Ontario
K1A 0K9
or
Fax to: (613) 957-6711

New Applications
New applications should be submitted once a company has received their DIN or is ready to begin licensable activities. All parts of the application must be completed.

Amendments
Amendments are to be submitted within 15 days of making the change or as part of the annual renewal process if the change is within 15 days of submitting the renewal. Amendments are required to add or change any of the following:

• activities, categories and dosage forms of drugs,
• sterile fabrication of a dosage form,
• a site (building) engaged in licensable activities,
• the address of the site (building) engaged in licensable activities,
• name of a company engaged in licensable activities (see below)
• activities, categories, dosage forms or sterile fabrication at an existing foreign site, and a new foreign site on an importer's licence (see Section 5 description).

Amendment to Change a Company Name
Companies may submit a letter on company letterhead detailing the name change. This is allowable 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. This is applicable to both domestic companies and foreign sites.

Company Buy-Out/Merger
Companies may submit letters from companies being merged and the name of the merged company. A new application form should be submitted.

Amendment to Add or Change a Foreign Site
See Section 5 description.

Explanation of the Drug Establishment Licence Application Form

Application Type

If you are applying for a new Drug Establishment Licence then place an "x" after "New".
If you are requesting an amendment to a previously issued Drug Establishment Licence, then state the licence number after"Amendment to Licence Number".

The licence application form is comprised of two parts:

Part A which pertains to company information.
Part B which pertains to site information where the licensable activities e.g., fabricating, are taking place.

On the application form where appropriate, indicate your response with an "x".

Part A: Company Information

This information pertains to the company applying for the Drug Establishment Licence.

If the company has different sites but wishes to have all the sites on the same licence there is no need to submit multiple copies of Part A, one will suffice. The multiple sites will appear in Part B: Site 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 invoice is to be sent.

[Name of Authorized Signing Official] is the individual who is responsible for preparing the application. This individual will be the contact for inquiries regarding the application.

Part B: Site Information

If a company has activities at more than one site then a Part B must be completed for each site. For administrative purposes the company must designate each site as A, B, C, D ... by circling or entering the appropriate code in the Canadian Site box in the upper right corner of each page of Part B.

[Narcotic Licence Number (s)] must be entered if you are currently licenced. Please indicate the Narcotic Licence Number on the form.

Section 1: Location

This section refers to the physical location of the site(s) in Canada.

[Building Name] is a name which a company uses to identify a site/building.
[Building No.] is a number which a company uses to identify a site/building.

These fields are completed only if the company identifies a site/building by a particular name or number.

[Dwelling House] is a house where a site is located. If the site is located in a dwelling house, place an "x" before yes, if not place "x" before no.

[Address Information] is the address where the site is located. This cannot be a post office box.

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

[The Contact Person] is the individual at the site who will be contacted in case of an emergency.

Section 2: GMP Inspection Information

Applicants are asked to indicate whether or not the site has been inspected by a Health Products and Food Branch Inspectorate Inspector. If the response is yes, the date of the last inspection is also required. Please note that other kinds of activity conducted by Health Canada personnel (e.g. on-site evaluations by Biologics and Genetics Therapies Directorate for New Drug Submissions) are not GMP inspections.

Section 3: Activity, Category and Dosage Form Class Information

This section refers to information regarding the Activities, the Category of products which the company handles at this site and the Dosage Form Class (e.g. Fabricate, Pharmaceutical, Tablet, Solution) of the products.

The possible Activities and Categories of products have been coded 1-6.
The Dosage Form Classes have been coded 1-12. (The dosage form must be assigned from only these classes.)

For further information about determining the dosage form class, please refer to the Drug Establishment Licensing Guidance Document. There are often specific dosage forms which are grouped into a Dosage Form Classes. For example, creams and ointments are considered suspensions.

Code 12 applies to "other" dosage form classes as designated by the Minister.

"Other" Dosage Form Classes Designated by the Minister

Bar
Biscuit
Cigarette
Cement
Dressing
Graft
Gum
Implant
Leaf
Lozenge/Candy/Cough Drop
Pad/Patch
Paper
Pencil
Plaster
Slow Release Ring
Seed
Soap/Cake
Sponge
Sustained-release disc
Stick
Strip
Suture
Tape
Teat Dilator
Tea
Tampon
Wafer
Wipe
Wire

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 then you would enter in the spaces at the bottom of the table A= Implant, B= Dressing. Then you would insert "A" and "B" in the appropriate fields/boxes in Column 12 of the table.

For each activity, at least one category must be assigned. If more than one category applies to an activity (e.g., a company fabricates vaccines and biologicals), more than one entry is required. Insert the number code for the appropriate activity (ies) and category (ies). The appropriate dosage form boxes can then be completed (See above).

If a dosage form class utilizes sterile production techniques, annotate with "S" before the "x" or "A" "B" ... in the appropriate column.

Section 4: Product Information

NOTE:

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

This section contains information about the drugs that the applicant fabricates, packages/labels or distributes.

[Canadian Site A, B, C, D] is the code which the applicant has used for this site. (See beginning of Part B.)

[Brand Name] is the name under which the product is sold/distributed.

[DIN] is the Drug Identification Number assigned to a product. It must be included unless not required by regulation (e.g., blood).

For information about obtaining a DIN, please refer to the document HC SC 3011: Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation
http://www.hc-sc.gc.ca/dhp-mps/index-eng.php
or contact Submission and Information Policy Division (Phone: (613) 954-3067,
Fax: (613) 941-0825)

[Activity] is described above in Section 3. For each product, mark with an "x" the activity (e.g., 1 = Fabricate, 2 = Package/Label, 5 = Distribute) that applies to it.

Section 5: Foreign Site Information (Required for Importers Only)

Products from foreign fabricators, packagers/labellers and/or testers must be imported into Canada by a licensed importer. This Section contains information about the foreign site(s) where the product is either fabricated packaged/labelled, or tested.

[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.

[Category and Dosage Form Class Information]

This refers to information regarding the Category of products which the company handles at this site and the Dosage Form Class (eg. Fabricate, Pharmaceutical, Tablet, Sterile Solution, Suspension) of the products.

Categories of products have been coded 1-5.
The Dosage Form Classes have been coded 1-12. (The dosage form must be assigned from only these classes.)

Code 12 applies to "other" dosage form classes as designated by the Minister.

"Other" Dosage Form Classes Designated by the Minister

Bar
Biscuit
Cigarette
Cement
Dressing
Graft
Gum
Implant
Leaf
Lozenge/Candy/Cough Drop
Pad/Patch
Paper
Pencil
Plaster
Slow Release Ring
Seed
Soap/Cake
Sponge
Sustained-release disc
Stick
Strip
Suture
Tape
Teat Dilator
Tea
Tampon
Wafer
Wipe
Wire

At the bottom of the table there is an area to code these"other" Dosage Forms. For example if you produce an implant and a dressing then you would enter in the spaces at the bottom of the table A= Implant, B= Dressing. Then you would insert "A" and "B" in the appropriate fields/boxes in the Column 12 of the table.

For each category, several dosage forms can be assigned. Insert the number code for the appropriate category. The appropriate dosage form boxes can be marked with an "x" with the exception of 12 (See above).

If a dosage form class utilizes sterile production techniques, annotate with "S" before the "x" or "A" "B" ... in the appropriate column.

Product Information

This section contains information about the products that are fabricated, packaged/labelled, or tested at this foreign site and which the applicant imports.

[Brand Name] is the name under which the product is sold/distributed.

[DIN] is the Drug Identification Number assigned to a product. It must be included unless not required by regulation (e.g., blood)

[Activity] e.g., 1 = Fabricate, 2 = Package 3 = Test
For each product, mark with an "x" the activity that applies to it.

Amendment to Add a Foreign Site

Importers must complete and submit a copy of Section 5 of the application form when adding a new foreign site. A brief cover letter from the importer should accompany the Section 5 along with appropriate GMP information as described in the document Conditions For Acceptance of Foreign Inspection Reports. This document is located on the Inspectorate website:

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index-eng.php

In addition please note that on-site evaluations done for New Drug Submissions are not considered acceptable GMP evidence.

Drug Establishment Licence Application Form

Application Type

• New
• Amendment to Licence Number

Part A: Company Information

Company Name:

Mailing Address

Street:

Suite:

Post Office Box:

City:

Province:

Postal Code:

Attention:

Language:

• English
• French

Telephone:

Fax:

E-Mail

Billing Address () same as mailing address

Street:

Suite:

Post Office Box:

City:

Province:

Postal Code:

Attention:

Language:

• English
• French

Telephone:

Fax:

E-Mail

Name of Authorized Signing Official

Title

Signature

Date

Part B: Site Information

Canadian Site A B C D

Narcotic Licence Number:

Section 1: Location

Building Name:

Building No:

Dwelling-house:

• yes
• no

Address Information:

• same as mailing address
• same as billing address

Street:

Suite:

Post Office Box:

City:

Province:

Postal Code:

Attention:

Language:

• English
• French

Telephone:

Fax:

E-Mail

GMP Records Maintenance Address:

• same as location address
• same as mailing address
• same as billing address

Street:

Suite:

Post Office Box:

City:

Province:

Postal Code:

Attention:

Language:

• English
• French

Telephone:

Fax:

E-Mail

Section 2: GMP Inspection Information

This site has been inspected by a Inspectorate Inspector:

• yes
• no

Date of last inspection:

• Year
• Month
• Day

Section 3: Activity, Category and Dosage Form Class Information

Activity (A)

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

Category (C)

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

Dosage Form Class

1 = Parenteral
2 = Tablet
3 = Capsule
4 = Solution
5 = Suspension
6 = Aerosol
7 = Powder
8 = Suppository
9 = Medical Gas
10 = Veterinary Premix
11 = Bulk Intermediates
12 = Other

Enter only ONE activity and ONE category per line

e.g., A =1 C=1 1= 2=x 3= 4=*Sx 5= 6= 7= 8= 9= 10= 11= 12=A, B

* An "S" should be placed in front of the "X" to indicate that the product is sterile

A = B = C = D =

Canadian Site A B C D ___

Section 4: Product Information

Brand Name

DIN

Activity: 1 = Fabricate 2 = Package/Label 5 = Distribute

• 1
• 2
• 5

Canadian Site A B C D

Section 5: Foreign Site Information (Required for Importers Only)

Foreign Company Name:

Foreign Site Address

Street:
City:
Province/Region:
Country:
Postal/Zip Code:

Category and Dosage Form Class Information

Category (C)

1 = Pharmaceutical
2 = Vaccine
3 = Blood & Blood Components
4 = Biological
5 = Radiopharmaceutical

Dosage Form Class

1 = Parenteral
2 = Tablet
3 = Capsule
4 = Solution
5 = Suspension
6 = Aerosol
7 = Powder
8 = Suppository
9 = Medical Gas
10 = Veterinary Premix
11 = Bulk Intermediates
12 = Other

(enter only ONE category per line)

e.g., A =1 C=1 1= 2=x 3= 4=*Sx 5= 6= 7= 8= 9= 10= 11= 12=A, B

* An "S" should be placed in front of the "X" to indicate that the product is sterile

A = B = C = D =

Product Information

Brand Name

DIN

Activity: 1 = Fabricate 2 = Package 3= Test

• 1
• 2
• 3