An importer of record requires:
Canadian importer of record can provide all of the following to save on operational costs:
Begin process to
obtain market authorization and
DEL at the
Once Health Canada has granted market authorization for a drug, the country's public and private drug plans must decide if it is eligible for reimbursement.
Manufacturers who wish to market a pharmaceutical product in Canada must obtain authorization from Health Canada.
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The Road to Commercialization in Canada
Each route has different implications on timeline, resources & commercialization strategy
New Drug Submission (NDS) to Health Canada
• Safety, efficacy, quality data review
If a positive market authorization decision
• Notice of Compliance (NOC) provided
• Drug identification Number (DIN) issued
A "bricks and mortar" location in Canada, which involves capital investment, warehouse facilities, domestic resources,
a DEL, SOPs, regulatory inspection, etc.
Certified Quality Assurance (QA) personnel for final product release authority
Understanding the licensing and regulatory approval processes to market and sell a pharmaceutical product in Canada.
WANT TO START YOUR COMMERCIALIZTION JOURNEY IN CANADA?
Read our article on KnowledgeDriven.com,
Healthcare Delivery in Canada