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

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.