Share your views: Consultation opened for guidance on applications and service standards (GUI-0127)
From: Health Canada
Current status: Open
Opened on December 5, 2023, and will close to new input on February 2, 2024.
In an effort to increase predictability and transparency for industry, Health Canada has revised the guidance on applications and service standards for drug establishment licences (GUI-0127). The revised guidance contains new information on application streams and service standards.
Join in: how to participate
Email us to request the consultation package and submit your comments by February 2, 2024
Who is the focus of this consultation
We will engage with Canadian:
- drug establishment licence (DEL) holders
- groups or associations that represent DEL holders
- groups or associations with an interest in the regulation of safe and effective medicines
To enhance clarity and to reflect improved practices, we made changes in several sections.
Examples of content changes we made include:
- new application streams and service standards
- more in-depth and transparent overview of Health Canada’s drug establishment licence (DEL) application review process
We also edited and formatted the guidance document to make it easier to understand.
The input gathered through this process will be considered in the final publication of GUI-0127. It is important to note that the service standards and timelines provided in the document for consultation are not final. They are subject to change before we publish the final guidance.
- Current published version of GUI-0127:
Health Product Inspection and Licensing Division
Health Product Compliance Directorate
13th Fl, Jeanne Mance Building
200 Eglantine Driveway, Tunney's Pasture
Address Locator # 1913D
Ottawa ON K1A 0K9
- Date modified: