This Presolicitation opportunity from Government of Canada was posted on October 4, 2024. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Seeking Expression of Interest in Obtaining Canadian Licensure for Transdermal Scopolamine Patch

Closed

W6369-24-A013International

Submission Closed10/04/2024, 02:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325412

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Solicitation # SSN-CPSU-1533180

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AI Contract Overview

The Department of National Defence and the Canadian Armed Forces are seeking expressions of interest from providers willing to obtain Canadian regulatory approval and licensure for an extended-release transdermal scopolamine patch. The product is intended for use during operations, exercises, and taskings to prevent nausea and vomiting associated with motion sickness, as there is currently no marketed version of this patch available in Canada. To enter the Canadian market, the product must be regulated as a Natural Health Product, requiring a Class III product license application and a site license for manufacturing, packaging, labeling, or importing. The product license application typically has a review period of 210 calendar days, while site license applications generally take between 30 and 90 days, with no current costs associated with these reviews. This presolicitation notice, identified by solicitation number W6369-24-A013, is an inquiry to determine industry interest and does not constitute a commitment to issue a formal request for proposals or incur costs.

General Info

DND seeks providers to obtain Canadian regulatory approval for transdermal scopolamine motion sickness patches.

Agency

Government of Canada → Department of National Defence

NAICS

325412 - Pharmaceutical Preparation Manufacturing

Place of Performance

*Canada, CAN

Set-Aside

NONE

Documents

letter-of-interest

Low

AI Contract Breakdown

Uniform Contract Format

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Timeline

PhaseClosed

PostedOct 4

Solicitation

Response DeadlineOct 4

Deadline has passed

Submission Closed

10/04/2024, 02:00:00 PM UTC

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Organization & Contact Information

AgencyGovernment of Canada → Department of National Defence

Contacts1 person available

OfficeN/A

Organization / AgencyGovernment of Canada → Department of National Defence

Office AddressN/A

Contacts

Scott SerafinPoint of Contact

Full 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.