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Earlier capture
Fees for the Review of Human and Veterinary Drug Establishment Licence Applications - Canada.ca
Apr 18, 2025
legacy-hc-2025-04-21
ID 211573
Later capture
Fees for the Review of Human and Veterinary Drug Establishment Licence Applications - Canada.ca
Jan 2, 2026
hc-20260101
ID 428914
updated6 sections changed
6 sections changed0 added0 removed+10 / -15 linesChange ratio: 3%
--- +++ @@ -34,7 +34,7 @@ Appendix A - Elimination of fee deferrals and remissions Appendix B - Examples of how DEL fees for foreign buildings are calculated for each application type Related guides and help-How to Pay Your Establishment License Fees+How to Pay Health Canada Fees Information on how to register as a Small Business Performance Standards for Fees in Respect of Drugs and Medical Devices Order Management of Applications and Performance for Drug Establishment Licences (GUI-0127)@@ -204,7 +204,7 @@ 3.1 Timing of fee payment Following Drug Establishment Licence (DEL) screening and upon determination that the application is accepted for further review, Health Canada will issue a notice to the applicant and an invoice for the applicable fee. For information about the DEL application and licensing process, please refer to the Management of Applications and Performance for Drug Establishment Licences (GUI-0127) and the Drug Establishment Licence Application: Forms and Instructions (FRM-0033). Fees may be paid by credit card (Visa, MasterCard, or American Express), cheque, money order, international bank draft, or bank wire. All payments must include a reference to the DEL licence number or company's Health Canada account number to avoid delays or errors. Further instructions for the payment of fees are outlined in-How to Pay Your Establishment License Fees+How to Pay Health Canada Fees . 3.2 Late payments Payment is due upon issuance of the invoice. Interest on overdue accounts begins to accrue 30 days from the date of invoice issuance.@@ -216,16 +216,14 @@ ar-cr@hc-sc.gc.ca . 3.3 Overpayments-Any overpayment of fees will automatically be credited to the associated account. To request a refund of a credit balance, a written request must be submitted by email to the-Cost Recovery Invoicing Unit-at+Any overpayment of fees will automatically be credited to the associated account. To request a refund of a credit balance, a written request must be submitted by email to the Cost Recovery Invoicing Unit at criu-ufrc@hc-sc.gc.ca .-Applicants may also request that their credit balance be applied to their account toward future fees. Applicants wishing to do so must submit a request to the-Cost Recovery Invoicing Unit+Applicants may also request that their credit balance be applied to their account toward future fees. Applicants wishing to do so must submit a request to the Cost Recovery Invoicing Unit at+criu-ufrc@hc-sc.gc.ca and attach a copy of their most recent statement, indicating the account or client number, as well as the available credit amount.-Applicants wishing to dispute the fee indicated on their invoice may submit a request for reconsideration by email to the-Cost Recovery Invoicing Unit+Applicants wishing to dispute the fee indicated on their invoice may submit a request for reconsideration by email to the Cost Recovery Invoicing Unit at+criu-ufrc@hc-sc.gc.ca . To ensure the processing of an application is not impeded by a cost recovery hold, it is important that applicants pay their fee on time, even as Health Canada investigates a fee disagreement. Once the review of the fee is complete, any outstanding credits will be issued. 3.4 Fee mitigation and exemptions Two types of fee mitigation are available:@@ -306,8 +304,6 @@ Applicants with fee inquiries and/or those who wish to dispute a fee that is subject to this guidance document should contact: Cost Recovery Invoicing Unit Health Canada-200 Eglantine Driveway, Tunney's Pasture-Ottawa, Ontario K1A 0K9 By email: criu-ufrc@hc-sc.gc.ca Invoice Payment Inquiries@@ -317,7 +313,7 @@ 161 Goldenrod Driveway, Tunney's Pasture Ottawa, ON K1A 0K9 By email:-ar-cr@canada.ca+ar-cr@hc-sc.gc.ca By phone: 613-957-1052 or 1-800-815-0506 By fax: 613-957-3495 Appendix A: Elimination of fee deferrals and remissions@@ -325,7 +321,7 @@ Please contact the Cost Recovery Invoicing Unit if your application remains under fee deferral and you have any questions about that status. Appendix B: Examples of how DEL fees for foreign buildings are calculated for each application type Example 1. New DEL Application or Reinstatement-The following scenario walks through a new DEL application or a reinstatement application and its associated fees related to foreign buildings. The application profile is for human drugs.+The following scenario walks through a new DEL application or a reinstatement application and its associated fees related to foreign buildings. The application profile is for human ndrugs. Snapshot of the application: Foreign buildings listed on the application Domestic buildings listed on the application@@ -406,5 +402,4 @@ 3 referrer Page details-Date modified:-2021-12-21+2025-11-17