Consultation opened for guidance on applications and service standards (GUI-0127)
Drug Establishment Licensing Bulletin 156, December 5, 2023
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About the consultation
In an effort to increase predictability and transparency for industry, Health Canada has revised the process and associated guidance on applications and service standards for drug establishment licences (GUI-0127). The revised guidance reflects changes to application service standards through the introduction of application streams. It has been released for consultation from December 5, 2023, to February 2, 2024.
Overview of key changes
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.
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 document.
How to participate
Email us to request the consultation package and submit your comments by February 2, 2024.
Email: hpil-consultation-ipsop@hc-sc.gc.ca
We will consider all comments when we finalize the guidance document.
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