Renewing foreign buildings with no updated good manufacturing practices evidence
Drug Establishment Licensing Bulletin 181, November 15, 2024
On this page
- About the changes
- Foreign buildings without updated GMP evidence
- How the information will be used
- Health Canada foreign onsite inspection requests
- Foreign buildings supplying active pharmaceutical ingredients
- 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 (FB) annex. As indicated in DEL Bulletin 174 on July 9, 2024, this temporary measure will be lifted on December 31, 2024.
Drug establishment licence (DEL) holders who relied on this temporary measure must submit a DEL amendment application (with updated good manufacturing practices (GMP) evidence) to renew the foreign building before January 1, 2025. If a DEL amendment application is not submitted before this date, Health Canada will begin the process of removing foreign buildings with an expired NERBY date from the associated DEL.
If your expired or soon-to-be-expired foreign building meets the requirements outlined in DEL Bulletin 174, continue to follow the guidance outlined in the bulletin. Submit your DEL amendment application (with updated GMP evidence) as soon as possible.
Learn more:
Foreign buildings without updated GMP evidence
Onsite inspections were postponed during the pandemic. Since then, trusted international regulatory authorities have been increasing their onsite inspections of foreign buildings, thus enabling DEL holders to obtain updated GMP evidence for the foreign buildings they use. As a number of these inspections still need to be conducted, Health Canada is introducing a risk-based NERBY extension process. This process considers feedback we received on the April 2023 proposal for DEL and GMP flexibilities and NERBY extensions.
As a DEL holder, you may request a risk-based NERBY extension for an expired or soon-to-be-expired foreign building if the building:
- has not had an inspection from a regulatory or qualified authority, or qualified body, within the last 3 years or
- has no planned inspection by a regulatory or qualified authority, or qualified body
Steps to take when requesting a risk-based NERBY extension
To support risk-based NERBY extension requests, we are launching the new Risk-based new evidence required by (NERBY) date extension Request Form (FRM-0559).
This form is a step-by-step guide. It will help you identify the information that we require to determine if a NERBY extension can be granted. The information is based on you attesting to GMP-related changes and other GMP updates to the foreign building’s operations since the last inspection conducted at the site. These changes pertain to:
- equipment
- key personnel
- facility changes
- manufacturing processes
You do not need to submit FRM-0559 if your foreign building has a planned inspection or has had an inspection but the inspection report has been delayed.
For information on how to submit a NERBY extension request:
If no updated GMP evidence available, submit a DEL amendment application to request a risk-based extension
Submit your DEL amendment application before January 1, 2025, and 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 any pertinent information that would help us review the application. For example, indicate if you are submitting a request for a risk-based extension of the foreign building’s NERBY date. Include relevant information about the nature of products impacted by the site (for example, urgent need for product, medically necessary, drug shortage).
FRM-0559
Submit FRM-0559 in PDF or Word format. Make sure each section is complete. If you have submitted an application and the foreign building is now eligible for a risk-based NERBY extension, we may ask you to complete the FRM-0559 through a deficiency notice, if applicable.
For a copy of the most recent version of this form, email us at foreign.site-etranger@hc-sc.gc.ca.
You do not need to submit this form if you have already submitted a request for a NERBY extension for a given foreign building as per the guidance under bulletin 174.
How the information will be used
We will review the information submitted in FRM-0559 to determine if a NERBY extension can be granted. Should gaps be identified, we may contact you for more information. In certain situations, we may conduct an onsite or remote inspection. We may also take additional steps as needed to mitigate any risks identified to protect the health and safety of people in Canada.
Foreign buildings granted an extension to the NERBY date will be assigned an extension of 1 to 2 years from January 1, 2025. The extension is based on the risk profile of the foreign building.
We will apply discretion based on risk when reviewing requests for a risk-based NERBY extension. There may be cases when the risk profile of a foreign building makes it ineligible for an extension to the NERBY date.
If a foreign building is eligible for a risk-based NERBY extension, we will consider a number of factors when granting the extension. For example:
- compliance history of the foreign building
- for example, past instances of non-compliance from Health Canada
- the activities taking place, and the categories and dosage forms being handled at the foreign building
- for example, whether there are changes that are not supported by the most recently submitted GMP evidence
- nature of the drugs
- for example, medical necessity, real or imminent drug shortage of a medically necessary drug
- inspection method of the most recent Health Canada inspection (onsite or remote inspection)
- whether the foreign building is eligible to be supported by the submission of a corporate or consultant audit
- assurance that certain aspects of GMP operations and any changes made to quality assurance management, equipment or manufacturing processes since the last inspection meet GMP requirements
If a risk-based NERBY extension was already granted to a given foreign building, you should not submit an application requesting a subsequent extension of the NERBY date. Also, you should let us know as soon as possible if a regulatory or qualified authority or qualified body has not confirmed a planned inspection of the foreign building.
Our review of FRM-0559 does not replace the review of an inspection report from a regulatory or qualified authority, or qualified body. If an inspection report from a trusted regulatory authority becomes available, you should inform us as soon as possible. We will prioritize the review of the inspection report over the review of FRM-0559.
The outcome of your request for a NERBY extension will be communicated to you once we have completed the review process for your application.
Applications with FRM-0559:
- are subject to processes and standards
- consult Management of application and performance for drug establishment licences (GUI-0127)
Learn more about when to submit this form and how we assess it:
- FRM-0559 (for a copy of the most recent version of this form, email us at foreign.site-etranger@hc-sc.gc.ca)
Health Canada foreign onsite inspection requests
You may have already submitted a request for an onsite inspection to renew your foreign building’s NERBY date and are waiting for us to confirm the planned inspection. If this is the case, you must also submit a DEL amendment application requesting a risk-based NERBY extension. You do not need to submit a request for a risk-based NERBY extension if we have already scheduled an onsite inspection of the foreign building.
We will prioritize onsite inspections based on the following details:
- nature of the product
- for example, medical necessity, real or imminent drug supply shortage of a medically necessary drug
- compliance history of the foreign building
- if other trusted regulatory authorities plan to inspect or have recently inspected the foreign building
- licensable activities conducted by the foreign building
- categories of drugs and dosage forms fabricated by the foreign building
Even after a request is made, importers should:
- continue to monitor for alternate GMP evidence for this site or
- identify other qualified suppliers with acceptable GMP evidence
Foreign buildings supplying active pharmaceutical ingredients
The temporary measures for foreign buildings performing activities with active pharmaceutical ingredients (API) will also be lifted on December 31, 2024. We know that stakeholders may continue to experience challenges with attesting to evidence for API sites on the API Foreign Building (FB) Annex.
Continue to:
- attest to the site’s compliance on Table A and FRM-0033 even if the GMP evidence is older than 3 years
- indicate on your cover letter if the site on Table A does not have recent GMP evidence
We are looking at ways to address sites on the API FB Annex that do not have recent evidence. We will communicate guidance in the near future.
Going forward
As of January 1, 2025, unless the foreign building is eligible for a NERBY extension, you will be required to submit new GMP evidence. The guidelines are indicated in How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).
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 and inquiries related to foreign onsite inspections: 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
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