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