The Road to Commercialization in Canada
Understanding the licensing and regulatory approval processes to market and sell a pharmaceutical product in Canada.
Manufacturers who wish to market a pharmaceutical product in Canada must obtain authorization from Health Canada.
Begin process to
obtain market authorization and
DEL at the
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
Each route has different implications on timeline, resources & commercialization strategy
An importer of record requires:
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
Canadian importer of record can provide all of the following to save on operational costs:
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.
WANT TO START YOUR COMMERCIALIZTION JOURNEY IN CANADA?
Read our article on KnowledgeDriven.com,
Healthcare Delivery in Canada
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