Guideline GUI-0127 has been Revised

Health Canada has revised the process and associated guidance on “Applications and Service Standards for Drug Establishment Licences” (GUI-0127) on December 4, 2024.

The document was formely called “Management of applications and performance for drug establishment licences”. Key changes include: new application streams and service standards; more in-depth and transparent description of Health Canada’s drug establishment licence (DEL) application review process.

Contact GMP Consultants to manage your DEL application, amendments and annual renewals.