Drug Establishment Licenses – Review Times
A Drug Establishment License is required by importers and distributors of drugs in Canada. Applications for Drug Establishment Licenses (DEL) are reviewed by Health Canada in order to confirm that all facilities included in the application are compliant with Good Manufacturing Practices of the Food & Drug Regulations. Health Canada’s performance standard for processing a DEL application is 250 calendar days.
This performance standard is also in place for DEL amendments submitted after licensing. Amendments are required when changes and updates to the supply chain are planned. Common amendments include adding a new foreign supplier, adding a new Canadian warehouse or 3 PL service provider, and adding a new activity (such as “package”) at a facility over and above the activities covered by the current DEL.
The full 250 days are required for review of DEL amendments because the amendments often involve an additional GMP evaluation by Health Canada. The evaluation may be paper based, or paper based plus inspection, depending on the changes proposed and facilities involved. When Health Canada is actively engaged in a review of a new DEL or a DEL amendment, the review “clock” will start and the 250-day period will begin from the day Health Canada deems submissions to be administratively complete.
The clock will pause however during the review process when deficiencies in the file are found by Health Canada and additional information is required in order for the review to continue. A deficiency notice will be issued by Health Canada to the DEL applicant. During this period the clock continues to be paused until all issues are resolved.
It is important to understand this process when working with multiple facilities as part of a single amendment. The review clock will not restart until issues and deficiencies are resolved at all facilities. This can be problematic when a particular facility is not prepared to meet GMP compliance requirements and slows down the review process for the other facilities in the supply chain. Execution of a DEL strategy becomes especially important therefore for larger supply chains in order to avoid delays in operations for importing and selling drugs in Canada.
Health Canada has prepared a new guidance document, Management of Applications and Performance for Drug Establishment Licenses (GUI-0127) soon to be available on their website. The guidance explains the DEL submission process with some easy-to-follow explanation of submissions needed when changes to the supply chain are planned. The distinction between DEL amendments vs notifications (for administrative changes) will be especially helpful for those involved in DEL buyouts and company mergers.
