What you need to know about renewing your Drug Establishment Licence (DEL)
By Innomar Strategies
Each year, all DEL holders are required to renew their licence by March 31st to maintain compliance with Health Canada. Below is an overview of the renewal process, with Innomar Strategies available to provide support and answer your questions along the way.
The renewal process involves three main activities:
- Annual Licence Review Application Form
- Drug Identification Number (DIN) Annex
- Table A Annex
- The Annual Licence Review Application Form
The Annual Licence Review Application Form is a vital document that lists the details of the activities and sites authorized under your licence. This is your opportunity to confirm that Health Canada has the correct information on file associated with your current licensable activities. If any details regarding your company profile or contact information are incorrect or require revisions, these changes can be made directly on this form. If any additions to the activities or sites listed on this form are required, a DEL application will need to be completed. However, if a site or activity is no longer needed, it can be removed by simply putting a line through the name of the site and/or activity currently listed. This form is then signed to confirm that all sites and/or activities are correct or have been updated where applicable.
- DIN Annex
All DEL holders must confirm the link between each of their DINs and the site of fabrication or packaging. Where a product is a controlled substance, each DIN is also linked to its test sites. The DIN Annex is populated based on the previous year’s renewal. If there have been no changes since the last renewal, you can likely complete this section by entering “Maintain” next to each pre-populated entry.
If there were changes to your sites or DINs over the year or if information in the DIN Annex is incorrect, you will need to update this list by adding a line for each DIN next to its site of fabrication and packaging (and testing for controlled substances). The complexity of the DIN annex can increase significantly based on the number of DINs and sites you have. For example, if you have five DINs all manufactured and packaged using four different sites, you will require twenty lines on your DIN Annex.
- Table A Annex
As a part of the Drug Establishment Licencing process, each active pharmaceutical ingredient (API) supplier is linked to the finished drug product manufacturer on the Table A. During the Annual Licence Renewal, the content of the current Table A Annex is reviewed and you have the option to either maintain the site on the Table A or remove it. Any other changes to the Table can only be made by submitting a DEL amendment.
At the end of the review of your renewal application, if all information is deemed acceptable, the DEL office will issue an invoice for your renewal. Once this invoice is paid, your renewal is considered complete.
Note: The ALR must be submitted no later than March 31 or your DEL will be suspended.
Source: Annual Licence Review Instructions. Health Canada.
The information provided in this piece does not constitute legal advice. Innomar Strategies Inc. and its parent Cencora, Inc. strongly encourage the audience to review available information related to the topics discussed to rely on their own experience and expertise in making decisions related thereto. Further, the contents of this piece are owned by Innomar Strategies, and reproduction is not permitted without the consent of Innomar Strategies.
