Newfoundland and Labrador - Apply for Drug Establishment Licence

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Procedure

Apply Through Email

1. To obtain a drug establishment license, the applicant has to fill in an application form with all relevant details, use the following link to download the application form: Link
2. Once the application form is displayed click on the “New Application” option, scroll to the bottom and fill in all the relevant details.
3. If the applicant needs help filling in the application form, refer to the link under the “Information which might help” section of this page.
4. Attach all relevant documents to the application form. Find documents under the “Required Documents” section of this page.
5. The applicant has to send the application form along with the documents to the following email: [email protected].
6. The applicant will need to pay a fee. The fee will be calculated once the application is submitted. Find fee-related information under the “Fees” section of this page.
7. Once the application form has been submitted, and the fees paid the authorities will give further instructions to the candidate.
8. The applicant’s company will be assigned a compliance officer, who will perform an inspection, the company is also audited to make sure they are complying with the Canadian Good Manufacturing Practices.

Apply Through Mail

1. To obtain a drug establishment license, the applicant has to fill in an application form with all relevant details, use the following link to download the application form: Link
2. Once the application form is displayed click on the “New Application” option, scroll to the bottom and fill in all the relevant details.
3. If the applicant needs help filling in the application form, refer to the link under the “Information which might help” section of this page.
4. Attach all relevant documents to the application form. Find documents under the “Required Documents” section of this page.
5. The applicant will need to mail the application form along with the documents to the following mail address: Drug Establishment Licensing Unit Jeanne Mance Building 200 Eglantine Driveway Address Locator #1913B Ottawa, Ontario K1A 0K9.
6. The applicant will need to pay a fee. The fee will be calculated once the application is submitted. Find fee-related information under the “Fees” section of this page.
7. Once the application form has been submitted, and the fees paid the authorities will give further instructions to the candidate.
8. The applicant’s company will be assigned a compliance officer, who will perform an inspection, the company is also audited to make sure they are complying with the Canadian Good Manufacturing Practices.

Apply Through Fax

1. To obtain a drug establishment license, the applicant has to fill in an application form with all relevant details, use the following link to download the application form: Link
2. Once the application form is displayed click on the “New Application” option, scroll to the bottom and fill in all the relevant details.
3. If the applicant needs help filling in the application form, refer to the link under the “Information which might help” section of this page.
4. Attach all relevant documents to the application form. Find documents under the “Required Documents” section of this page.
5. The applicant will need to mail the application form along with the documents to the following fax number: 1 613-957-4147
6. The applicant will need to pay a fee. The fee will be calculated once the application is submitted. Find fee-related information under the “Fees” section of this page.
7. Once the application form has been submitted, and the fees paid the authorities will give further instructions to the candidate.
8. The applicant’s company will be assigned a compliance officer, who will perform an inspection, the company is also audited to make sure they are complying with the Canadian Good Manufacturing Practices.

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Required Documents

• Cover letter (If applicable)
• Table A (If applicable). The applicant can request the most recent version here: [email protected].
• Good Manufacturing Practices (GMP) evidence to support the addition/renewal of foreign buildings Complete PART B > Section 5 for each foreign building.

Office Locations & Contacts

General enquiries: [email protected]
Foreign building GMP enquiries: [email protected]
General GMP enquiries: [email protected]
Application Inquiries:
Drug Establishment Licensing Unit
Health Canada
200 Eglantine Driveway, Tunney's Pasture
Ottawa, Ontario K1A 0K9
Contact Link

Eligibility

• The applicant fabricates/packages human and/or veterinary drugs.
• The applicant label or import, distribute, wholesale or test human and/or veterinary drugs then the applicant must apply for a drug establishment license.

Fees

• The applicant can pay the fee using cheque and must be made payable to the “Reciever General of Canada” and must be submitted to the following address with the invoice:

Health Canada Accounts Receivable

• P/L: 1918B, 18th Floor, Room 1804B 161 Goldenrod Driveway, Tunney's Pasture Ottawa, Ontario, K1A 0K9
• The applicant can pay using a credit card, fax the information to the following number: Fax: 613-957-3495 (Please complete and include this Fax Form: Link) or pay using Phone: 1-800-815-0506
• The applicant can pay using wire transfer, find information here: Link
• The applicant can calculate the fee here: Link
• Fee: Link
• Fee-related query: [email protected]
• API-related enquiries: [email protected]

Validity

• The license comes with an expiry date and this differs for every company.

Documents to Use

• Application form Link

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Please explain processing time taken in obtaining the document/certificate.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&>
from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Currently, during the covid19 pandemic, priority is given to applications that support the response to the pandemic and this includes the following drugs.
  • Medically necessary drugs.
  • Drugs on the tier 3 drug shortage list.
  • Designated drugs listed for exceptional importation and sale (for guidance on how to propose an addition to the list, see the webpage for the industry).
  • Other drugs are considered important to mitigate the risks of COVID-19.

Required Information

• Application type
• Company information
• Canadian building information
• Activity
• Category
• Drug class
• Class
• Product information
• Foreign building information
• Canadian warehouse
• Alternate sample retention site
• Small business mitigation
• DEL calculation chart
• Company name
• Is this establishment a DIN owner
• Drug class
• Building name or number
• Street
• City
• Suite and PO box
• Province
• Postal code
• Contact person
• Language
• Telephone
• Fax
• Email
• Billing address
• Emergency contact information
• Signature of signing authority
• Drug GMP inspection information
• Domestic finished dosage form
• Domestic active pharmaceutical ingredient (API) information
• Domestic FDF class product information
• Foreign building information
• Activity, category and dosage form class information
• Attestation and undertaking
• Signature

Need for the Document

• A Drug Establishment License is a mandatory document that is required by law if the applicant is involved in the fabrication, packaging, distribution and wholesale of drugs that are used for humans and/or for veterinary practices.

Information which might help

• Guidance on drug establishment licenses: Link
• Application form help: Link

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Place some external links which might help.

Others

More information which might help people.