Health Canada outlines plan for the future of DEL and GMP flexibilities

Drug Establishment Licensing Bulletin 162, January 9, 2024

Over the course of the pandemic, Health Canada introduced temporary measures in response to challenges created by the COVID-19 pandemic. This was done to safeguard access to high-quality drugs for people in Canada.

After receiving feedback from stakeholders and partners in April 2023, we revised our proposed Plan for the Future of DEL and GMP Temporary Measures. The revisions address identified concerns and consider ongoing program improvements.

The revised plan sets out timelines for when the temporary measures will end. We have also touched on the changes we will make to modernize DEL and GMP requirements.

DEL holders will be expected to implement any necessary changes to their operations and DEL applications to meet these timelines and expectations.

Contact us

Contact the Health Products Inspection and Licensing Division by email:

• About the final plan and for a copy: del.questions-leppp@hc-sc.gc.ca
• General DEL questions: del.questions-leppp@hc-sc.gc.ca
• Submit DEL applications: el.applications-le@hc-sc.gc.ca
• Foreign building GMP questions: foreign.site-etranger@hc-sc.gc.ca
• Domestic GMP questions: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca
• API questions: api.questions-ipa@hc-sc.gc.ca