Renewing foreign buildings with expired new evidence required by (NERBY) dates

Drug Establishment Licensing Bulletin 174, July 9, 2024

On this page

• About the changes
• Steps to take and how to submit
• Going forward
• Contact us

About the changes

On January 9, 2024, Health Canada announced that the temporary measures in response to challenges created by the COVID-19 pandemic would be lifted. One of these measures was to provide an indefinite extension to the 'new evidence required by' (NERBY) dates assigned to foreign buildings on the foreign building annex. This measure will be lifted on December 31, 2024.

You should start taking the following actions immediately in anticipation of the temporary measures lifting:

• Identify if your expired or soon-to-be-expired foreign buildings have recent good manufacturing practices (GMP) evidence and submit the evidence as an amendment application as soon as possible.
• If you do not intend to use a building with an expired or expiring NERBY date, submit an amendment application asking to have the foreign building removed from your DEL as soon as possible.

Do not wait until December 31, 2024, to initiate these actions. Applications received before September 30, 2024, with acceptable GMP evidence or an eligible request will receive an extra 3 months to the typical NERBY date.

For guidance, refer to How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).

Steps to take and how to submit GMP evidence

Follow these steps to identify and submit GMP evidence to renew foreign buildings with expired NERBY dates.

1. Identify more recent GMP evidence for your foreign building

Contact your expired or soon-to-be-expired foreign buildings to confirm if more recent GMP evidence is available.

You could also access the following public inspection databases to confirm that an updated inspection report exists:

• Health Canada's Drug and health product inspections
• United States Food and Drug Administration's data dashboard
• European Medicines Agency's EudraGMDP
• Medicines and Healthcare Products Regulatory Agency's GMP database
• Veterinary Medicines Directorate's Register of veterinary-only GMP sites
• World Health Organization's Public inspection reports

Note, however, that contacting your foreign building is the best way to identify the most recent GMP evidence available. This is because some foreign regulatory authorities (for example, under the Pharmaceutical Inspection Cooperation Scheme (PIC/S)) do not make their inspection information public.

Once you have identified recent GMP evidence, submit a DEL amendment application as soon as possible.

2. Submit a DEL amendment application to renew an expired or soon-to-be expired foreign building

Your DEL amendment application should include the following components:

Cover letter and FRM-0033

Make sure the application contains all applicable sections of the most recent version of the Drug establishment license application form (FRM-0033).

Include a cover letter, with information that may help us review the application. For example, indicate if the GMP evidence being submitted also supports the removal or amendment of existing terms and conditions associated with the foreign building.

Recent GMP evidence

Ensure the more recent GMP evidence meets the requirements of GUI-0080. The evidence should include:

• an inspection report from a qualified or regulatory authority with a compliant rating
• corrective actions, if applicable and
• a site master file or quality manual for applicable foreign buildings

We will also now accept inspection reports from the following authorities for foreign buildings on the foreign building annex:

• World Health Organization
• European Directorate for the Quality of Medicines

Extra-jurisdictional inspection outcomes

Foreign buildings with the most recent inspection from a Mutual Recognition Agreement (MRA) partner may be eligible for an extra-jurisdictional (EJ) certificate of compliance review.

For a list of MRA partners that we exchange EJ certificates of compliance with, visit the Mutual Recognition Agreements web page.

If the foreign building is eligible:

• ensure the EJ certificate is within the operational scope of the MRA and the validity period issued by the MRA partner
• submit a DEL amendment application asking us to obtain a copy of the EJ certificate from the MRA partner

Corporate or consultant audits

If a recent inspection from a regulatory or qualified authority is not available, you may submit a corporate or consultant audit for foreign buildings responsible for specific low-risk activities and product categories. Eligible activities and categories are listed in section 5.3.1 of GUI-0080.

If your eligible foreign building does not have an audit report available at this time, you should work with the foreign building to arrange for an audit as soon as possible. The report must be available before January 1, 2025.

NERBY extension request

As per GUI-0080, foreign buildings may be eligible for a NERBY extension under the following conditions:

• an inspection by a regulatory or qualified authority has taken place but there is a delay in the issuance of the inspection report
• an inspection by a regulatory or qualified is confirmed to take place

Refer to section 6 of GUI-0080 for how to submit a NERBY extension request. Applications eligible for a NERBY extension will be granted a NERBY date based on December 31, 2024, plus the additional time needed for the inspection report to become available.

Going forward

We are actively working with trusted international partners to exchange information related to inspection planning. We want to ensure as many sites are covered globally as possible and reduce duplication of inspections.

We will continue to reach out to importers to ask about the status of foreign buildings with expired NERBY dates to determine next steps.

Contact us

Contact Health Canada's Health Product Inspection and Licensing Division by email:

• Submitting DEL applications: el.applications-le@hc-sc.gc.ca
• Foreign building GMP evidence questions: foreign.site-etranger@hc-sc.gc.ca
• General DEL questions: del.questions-leppp@hc-sc.gc.ca
• Domestic GMP inspection questions: drug.gmp.questions-bpf.medicaments@hc-sc.gc.ca
• Active Pharmaceutical Ingredient (API) questions: api.questions-ipa@hc-sc.gc.ca