Updates to guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024)

Drug Establishment Licensing Bulletin 146, March 27, 2023

On this page

• Health Canada updates guidance
• What you need to know
• Webinar on key changes
• Contact us

Health Canada updates guidance

On March 27, 2023, Health Canada released an updated guidance on obtaining electronic certificates of pharmaceutical product and good manufacturing practices (GUI-0024).

The updates indicate that electronic certificates will now be issued. This follows a successful pilot for issuing electronic certificates for pharmaceutical products and good manufacturing practices.

This 2023 version replaces previous versions.

Health Canada continues to meet the requirements of the voluntary agreement set out in the World Health Organization (WHO) certification scheme. This agreement is outlined in the 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.

What you need to know

The shift to an electronic process is a significant development, providing a more efficient and secure means of applying for CPP and GMP certificates. Applicants should be aware of these changes and become familiar with the new process to ensure their applications are processed smoothly and without delay.

The updates reflect the following changes:

• Applications for a Certificate of a Pharmaceutical Product (CPP) and good manufacturing practices (GMP) certificates are now processed electronically. Paper submissions are no longer accepted.
• Applicants must submit their CPP and GMP certificate applications using the new version of the PDF fillable forms:
  • FRM-0454
  • FRM-0455
  • FRM-0456
• A new invoicing process has been implemented to safeguard payment information.
• Instructions on submitting an application have been revised to reflect the new electronic application process.

Webinar on key changes

We have a pre-recorded webinar that outlines the key changes to the guidance.

To access the webinar, you must first register with GCcollab, unless you are already registered. To request GCcollab registration, e-mail del.questions-leppp@hc-sc.gc.ca.

Once your account is created, you can access the Health product inspections and licensing group page. Access the GUI-0024 webinar in the 'files' section.

Contact us

You may email questions to us at cpp_questions@hc-sc.gc.ca.