Seeking Expression of Interest in Obtaining Canadian Licensure for Transdermal Scopolamine Patch
Solicitation number W6369-24-A013
Publication date
Closing date and time 2024/10/04 14:00 EDT
Last amendment date
Description
Letter of Interest
Subject: Seeking Expression of Interest in Obtaining Canadian Licensure for Transdermal Scopolamine Patch
The Department of National Defence (DND)/Canadian Armed Forces (CAF) is interested in obtaining an extended-release transdermal scopolamine patch for use on CAF operations, exercises, taskings, etc., to prevent nausea and vomiting associated with motion sickness. There is no marketed extended-release transdermal scopolamine patch in Canada, therefore, I'm reaching out to you to determine your interest in seeking regulatory approval/licensure of your transdermal scopolamine patch in Canada.
Scopolamine transdermal patches are regulated in Canada as Natural Health Products (NHPs), under the Natural Health Products Regulations (NHPR). To obtain an NHP license in Canada for a transdermal scopolamine product, a Class III NHP product license application (PLA) is required. The Natural Health Products Management of Applications Policy (NHP MAP) outlines the process applied by Health Canada to manage PLAs for NHPs submitted in accordance with the NHPR. The policy also outlines the responsibilities and expectations of NHP applicants throughout the application process. Currently, Class III applications have a performance standard of 210 calendar days for review, and there are no costs for the review or right to sell the product on the Canadian market.
A site license is required to manufacture, package, label or import NHPs for sale in Canada and is required before commencing any of these activities. The Site Licensing Guidance Document outlines the way in which Site License Applications for NHPs are submitted in accordance with the NHPR. Links to supporting documents can be found at Site Licensing Forms and Instructions and Site Licensing Guidance Documents. Currently, site license applications and amendments have a 30-90 calendar day performance standard, and there are no costs associated with the license.
Contract duration
The estimated contract period will be 36 month(s).
Trade agreements
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No trade agreements are applicable to this solicitation process
Reason for limited tendering
A contracting officer can use limited tendering for specific reasons outlined in the applicable trade agreements. The reason for this contract is described below:
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None
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Contact information
Contracting organization
- Organization
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Department of National Defence
- Address
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101 Colonel By
Ottawa, ON, K1A 0K2Canada
- Contracting authority
- Scott Serafin
- Phone
- (343) 542-3058
- Email
- Scott.serafin@forces.gc.ca
- Address
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101 Colonel By
Ottawa, ON, K1A 0K2Canada
Bidding details
Full details regarding this tender opportunity are available in the documents below. Click on the document name to download the file. Contact the contracting officer if you have any questions regarding these documents.
| Document title | Amendment no. | Language | Unique downloads | Date added |
|---|---|---|---|---|
| W6369-24-A013 - Letter of Interest - scopolamine patch - English.pdf | 001 |
English
|
21 | |
| W6369-24-A013 - Lettre d’intérêt - scopolamine patch - French.pdf | 001 |
French
|
1 |
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