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2025-05-01T04:30:18Z

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==Procedure==
'''Apply Through Email'''
#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 [https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033/frm-0033-fom-only-en.pdf Link]
#Once the application form is displayed click on the “New Application” option, scroll to the bottom and fill in all the relevant details.
#If the applicant needs help filling in the application form, refer to the link under the “Information which might help” section of this page.
#Attach all relevant documents to the application form. Find documents under the “Required Documents” section of this page.
#The applicant has to send the application form along with the documents to the following email: el.applications-le@hc-sc.gc.ca.
#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.
#Once the application form has been submitted, and the fees paid the authorities will give further instructions to the candidate.
#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'''
#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: [https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033/frm-0033-fom-only-en.pdf Link]
#Once the application form is displayed click on the “New Application” option, scroll to the bottom and fill in all the relevant details.
#If the applicant needs help filling in the application form, refer to the link under the “Information which might help” section of this page.
#Attach all relevant documents to the application form. Find documents under the “Required Documents” section of this page.
#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.
#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.
#Once the application form has been submitted, and the fees paid the authorities will give further instructions to the candidate.
#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'''
#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 [https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033/frm-0033-fom-only-en.pdf Link]
#Once the application form is displayed click on the “New Application” option, scroll to the bottom and fill in all the relevant details.
#If the applicant needs help filling in the application form, refer to the link under the “Information which might help” section of this page.
#Attach all relevant documents to the application form. Find documents under the “Required Documents” section of this page.
#The applicant will need to mail the application form along with the documents to the following fax number: 1 613-957-4147
#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.
#Once the application form has been submitted, and the fees paid the authorities will give further instructions to the candidate.
#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.
 
 
==Required Documents==
*Cover letter (If applicable)
*Table A (If applicable). The applicant can request the most recent version here: del.questions-leppp@hc-sc.gc.ca.
*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''': Hc.del.questions-leppp.sc@canada.ca 
'''Foreign building GMP enquiries:''' hc.foreign.site-etranger.sc@canada.ca 
'''General GMP enquiries''': hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca 
 
'''Application Inquiries:''' 
Drug Establishment Licensing Unit 
Health Canada 
200 Eglantine Driveway, Tunney's Pasture 
Ottawa, Ontario K1A 0K9 
Contact [https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002/document.html#s7 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: [https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/applications-submissions/form/credit-card-payment-eng.pdf Link]) or pay using Phone: 1-800-815-0506
*The applicant can pay using wire transfer, find information here: [https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/cost-recovery/pay-fees/establishment-licences.html Link]
*The applicant can calculate the fee here: [https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-drug-establishment-licence.html*a4 Link]
*Fee: [https://www.canada.ca/en/health-canada/services/drugs-health-products/funding-fees/review-drug-establishment-licence.html Link]
*Fee-related query: HC.CRIU-UFRC.SC@canada.ca
*API-related enquiries: hc.api.questions-ipa.sc@canada.ca
 
 
==Validity==
*The license comes with an expiry date and this differs for every company.

 
 
==Documents to Use==
*Application form [https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033/frm-0033-fom-only-en.pdf 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: [https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002/document.html*s7 Link]
*Application form help: [https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/forms/drug-establishment-licence-application-0033.html 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.
 
[[Category:Alberta]]

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Alberta - Apply for Drug Establishment Licence - Revision history

Wesley: Auto