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.
1,2
Begin process to
obtain market authorization and
DEL at the
same time
New Drug Submission (NDS) to Health Canada
• Safety, efficacy, quality data review
If a positive market authorization decision
is received:
• 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:
DEL services
QA services
Third-party logistics
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?
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Read our article on KnowledgeDriven.com,
Healthcare Delivery in Canada
Contact us through our website
www.innomar-strategies.com
Sources
1) http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/fs-fi/reviewfs_examenfd-eng.php
2) http://www.hc-sc.gc.ca/dhp-mps/prodphara/index-eng.php
3) http://www.hc-sc.gc.ca/dhp-mps/compli/licenses/drugs-drogues/index-eng.php
4) http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licenses/-doc/del-lepp-faq-eng.php#a2
