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:

Key changes

To enhance clarity and to reflect improved practices, we made changes in several sections.

Examples of content changes we made include:

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.

Related information

Contact us

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

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