Renewing Foreign Buildings with Expired GMP Evidence | Drug Establishment Licence (DEL) 

By: Steve McCarthy, DIRECTOR OF REGULATORY AFFAIRS, email

Published: July 9, 2024 – Drug Establishment Licensing Bulletin 174 

In early 2024, Health Canada lifted the temporary measures that allowed the indefinite extension of NERBY dates for foreign buildings, a policy initially introduced due to COVID-19-related challenges. Now, to remain compliant, all companies must submit updated Good Manufacturing Practice (GMP) evidence for foreign buildings by December 31, 2024. 

In this post, we’ll explore what the changes mean for Drug Establishment License (DEL) holders, key deadlines to watch out for, and how to submit acceptable GMP evidence to ensure compliance. 

What Are NERBY Dates and Why Are They Important? 

NERBY (new evidence required by) dates indicate when GMP evidence for foreign buildings must be renewed. During the COVID-19 pandemic, Health Canada temporarily allowed extensions of these dates, but that policy will end on January 1, 2025. 

If your company relies on foreign sites for drug manufacturing, packaging, labelling, testing it’s crucial to stay compliant. Failure to provide up-to-date GMP evidence by the deadline could lead to foreign buildings being removed from your Drug Establishment License, impacting your ability to operate smoothly. 

Upcoming Deadlines for Submitting GMP Evidence 

Here are the critical deadlines to keep in mind: 

• December 31, 2024: Last day to submit acceptable GMP evidence for foreign buildings. 
• January 1, 2025: Health Canada will start the process of removing non-compliant foreign buildings with expired NERBY dates from the DEL, affecting import and distribution capabilities. 

Pro Tip: Submit your DEL amendment application before September 30, 2024, to receive an additional 3-month extension on your NERBY date. 

How to Renew Foreign Buildings with Expired NERBY Dates

First: Identify Expired or Soon-to-Expire Buildings 
Start by reviewing your foreign sites and identifying any with expired or soon-to-expire NERBY dates. For these sites, you need to request updated GMP evidence. If a foreign building will not be renewed, you should submit a DEL amendment application to remove it from your license. 

Second: Where to Find GMP Evidence 
You can check the following public databases for inspection reports: 

• Health Canada’s Drug and Health Product Inspections 
• FDA’s Data Dashboard 
• European Medicines Agency’s EudraGMDP 
• MHRA GMP Database 
• World Health Organization’s Public Inspection Reports 

However, some foreign regulatory authorities do not make these reports publicly available. If needed, contact the foreign site directly to request recent GMP evidence. 

Third: What to Include in Your DEL Amendment Application 
When submitting your DEL amendment application, make sure to include the following: 

• Cover Letter and Form-0033: Fill out all applicable sections, and mention any relevant details, like updates to terms and conditions for the foreign building. 
• Recent GMP Evidence: This could include: 
• A compliant inspection report from a recognized regulatory authority. 
• Corrective actions for any observations made during inspections. 
• A site master file or quality manual, if applicable. 

Fourth: Alternative Forms of GMP Evidence 
If you cannot provide a recent inspection report, Health Canada also accepts: 

• Extra-Jurisdictional Certificates: Buildings inspected by Mutual Recognition Agreement (MRA) partners may be eligible for a certificate of compliance review. 
• Corporate or Consultant Audits: If no recent inspection is available, a corporate audit can be submitted for low-risk foreign building activities. Ensure the audit meets the qualifications outlined in GUI-0080. 

Fifth: Requesting a NERBY Extension 
In specific cases, you may request an extension on your NERBY date if: 

• An inspection has occurred, but the report has been delayed. 
• An inspection is scheduled with a qualified authority. 

Avoid Potential Consequences of Non-Compliance 

Failing to submit updated GMP evidence for foreign buildings by the deadline could have serious repercussions. Health Canada could start removing foreign buildings from your DEL, negatively impacting your ability to import or distribute drugs from those sites. 

To avoid disruptions, ensure that all GMP evidence is submitted on time. For companies needing assistance, Dell Tech can help you navigate the process of renewing NERBY dates, submitting DEL amendment applications, and staying compliant with Health Canada’s regulations. 

Next Steps 

1. Review your foreign buildings’ NERBY dates and request updated GMP evidence. 
2. Submit your DEL amendment application before the deadline. 
3. Reach out to Dell Tech for expert help with the process. 

For more details, you can read the full Drug Establishment Licensing Bulletin 174. 

Key Takeaways 

• Stay ahead by submitting updated GMP evidence for foreign buildings by December 31, 2024. 
• Submit before September 30, 2024, to receive a 3-month NERBY extension. 
• Dell Tech is here to help with all your DEL compliance needs. 

How Dell Tech Can Help 

At Dell Tech, we specialize in Drug Establishment Licensing (DEL) requirements, offering comprehensive support to ensure your operations are compliant and efficient. From preparing DEL amendment applications to verifying that your foreign sites meet Good Manufacturing Practices (GMP) compliance, our expert team simplifies the regulatory process, allowing you to focus on growing your business. Contact us today to learn how we can help streamline your DEL processes and ensure your success in the pharmaceutical industry!

FAQs 

What happens if I miss the December 31, 2024, deadline?
If you miss the deadline, Health Canada may begin the process of removing non-compliant foreign buildings from your DEL, which could disrupt your ability to import or distribute drugs from those sites. 

How do I know if recent GMP evidence exists for a foreign building?
You can check public databases like Health Canada’s Drug and Health Product Inspections or contact the foreign site directly if the information isn’t publicly available. 

Can I get an extension on a NERBY date?
Yes, you can request a NERBY extension if there is a delay in issuing the inspection report or if an upcoming inspection is confirmed. 

Dell Tech has provided professional, confidential consulting services to the specialty chemical
industry in Canada, the USA, Europe, and Asia for the last 40 years.