Canada and United Kingdom recognize extrajurisdictional good manufacturing practices inspections
Drug Establishment Licensing Bulletin 143, January 5, 2024
On this page
- New expanded scope
- About the changes
- Impact on DEL holders
- How to apply or amend a DEL using an EJ CoC
- Renewal of foreign buildings
- Contact us
New expanded scope
Changes have been made to Canada's mutual recognition agreement (MRA) with the United Kingdom (UK).
As of September 1, 2022, Canada and the UK will officially recognize good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions. These are known as extrajurisdictional (EJ) GMPs.
This new expanded scope will:
- enhance cooperation and regulatory alignment between Canada and the UK
- reduce the regulatory burden for Canadian importers:
- Health Canada, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate (VMD) will exchange GMP evidence in the form of a certificate of GMP compliance (CoC)
- this certificate attests to a facility's compliance with GMP requirements
This EJ recognition falls under the protocol for pharmaceuticals of the Canada-United Kingdom Trade Continuity Agreement. The protocol is called the Protocol on Mutual Recognition of the Compliance and Enforcement Programme on Good Manufacturing Practices for Pharmaceutical Products.
The European Union (EU) and Canada entered into a similar agreement in the spring of 2021.
Learn more:
- Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes
- Mutual recognition agreement between Canada and the United Kingdom
About the changes
Before September 1, 2022:
- Canada and the UK only exchange CoCs if GMP inspections were conducted for human and veterinary finished dosage form products within our jurisdictions
- Canada exchanged CoCs for inspections within Canada
- UK exchanged CoCs for inspections within the UK
- importers do not need to submit a drug establishment licence (DEL) application (FRM-0033) to renew the foreign building if it has a valid CoC showing that it is in compliance
Effective September 1, 2022:
- Health Canada, MHRA and VMD recognize EJ GMP inspections (those conducted outside our respective jurisdictions) and accept all new or previously issued EJ CoCs if they are within:
- the validity period listed on the CoC and
- the operational scope of the CUK TCA protocol for pharmaceuticals
- Health Canada, MHRA and VMD exchange EJ CoCs directly
- importers do not need to submit GMP evidence to us with their FRM-0033 to add or amend a foreign building when an EJ CoC is used to support GMP compliance
- we will request a CoC from MHRA and/or VMD during the review
- compliant foreign buildings will be given a new evidence required by (NERBY) date and importers will submit a DEL application to add or keep the foreign building on their DEL
- please refer to the application process outlined in this DEL bulletin
- there will be no changes to the process for foreign buildings located in an MRA country for which a CoC is used to support GMP compliance
- please refer to the guidance How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
Note that the GMP requirements outlined in the Food and Drug Regulations (regulations) must still be met. Health Canada's GMP requirements will still apply, including C.02.019 of the regulations for finished product testing requirements. There are no GMP exemptions for imported finished dosage form products from extrajurisdictional foreign buildings.
Learn more:
Impact on DEL holders
If you wish to import human and veterinary finished dosage form products from a foreign building that is not located in the UK but has been inspected by MHRA and/or VMD, you no longer need to submit GMP evidence to us. However, you must still submit a DEL application. We will then request a CoC from MHRA and/or VMD.
We will compare the information on the CoC against your application. We will add or keep the foreign building on your foreign building annex if the scope of the CoC:
- is within the CUK TCA protocol for pharmaceuticals and
- supports the activities, categories and dosage forms you requested
If we find the foreign building is compliant, we will assign a NERBY date to the building.
You may import from the foreign building once it is listed on your foreign building annex and there's a NERBY date.
How to apply or amend a DEL using an EJ CoC
To add or amend a foreign building to your DEL where the building is located outside the UK's jurisdiction but inspected by MHRA or VMD, include the following information in your application:
- Cover letter: Indicate that an EJ CoC is available for the foreign building located in a non-MRA country if the MHRA or VMD conducted a valid GMP inspection.
- FRM-0033: Fill out all applicable sections of the Drug establishment licence application form (FRM-0033)
Please follow these instructions to complete FRM-0033:
- Under Section 5.0, in the "Foreign company name and building address information" section:
- Building in an MRA country? Indicate "No"
- Are activities covered by an MRA? Indicate "Yes"
Image 1 - Text equivalent
A picture of Section 5 of the Drug Establishment License application form (FRM-0033). A red box emphasizes how to indicate a request for Health Canada to obtain an EJ CoC by selecting "No" under the question "Building in a Mutual Recognition Agreement (MRA) Country?" and "Yes" under the question "are activities covered by an MRA?". This is Health Canada's prompt to obtain an EJ CoC from our MRA partner.
The other form fields included in the image are as follows:
- Section 5.0 PDF foreign building information
- Foreign company name: Drug Company
- Foreign building name:
- Street: 123 Maple Street
- City: Greenwich
- Province/State: CT
- Country: USA
- Postal code/ZIP code: 90113
- Reason for submission: Renew. Add. Remove. Amend.
- In the "Required GMP evidence documents" section:
- Check off "Regulatory authority for a site outside its jurisdiction"
- Indicate the name of the regulatory authority that inspected the foreign building under "Specify authority" section (for example, MHRA)
Image 2 - Text equivalent
A picture of the Required GMP evidence documents section of the Drug Establishment License application form (FRM-0033). A red box emphasizes where to indicate which MRA partner Health Canada should obtain the EJ CoC from. Select "Regulatory authority for a site outside its jurisdiction" and specify the authority beside it.
The other fields included in the image are as follows:
- Required GMP evidence documents (select and complete all that apply)
- The final and most (within the last 3 years) inspection report signed issued by:
- Qualified authority for a site within its jurisdiction.
- Specify authority:
- Qualified authority for a site outside its jurisdiction.
- Specify authority:
- the corrective actions taken, signed by a responsible official of the foreign building (if applicable)
- a copy of the Site Master File, or a similar document such as a quality manual
- a Letter of Authorization (LoA) to reference a GMP evidence package from a previously submitted application
You must make sure that the CoC supports the activities, categories and dosage forms requested on FRM-0033. If:
- the CoC does not support these, you must submit alternate supporting GMP evidence as per GUI-0080 with your application
- you indicate that the supporting evidence is a CoC and the CoC does not support the activities, categories or dosage forms, we will reject the application as per the guidance document Management of applications and performance for drug establishment licence (GUI-0127)
Please note that active pharmaceutical ingredient (API), remote and hybrid inspections are outside the operational scope of the CUK TCA protocol for pharmaceuticals. Thus, they are not covered by extrajurisdictional CoCs.
Note: If Health Canada has previously given the foreign building a non-compliant rating, you must submit GMP evidence for review. This rating means that the foreign building will not qualify for an EJ CoC review.
Learn more:
Renewal of foreign buildings
You are responsible for submitting a renewal application for all foreign buildings assigned a NERBY date.
You must take 1 of the following 2 actions by the NERBY date to keep the foreign buildings on your foreign building annex:
- New CoC from MHRA/VMD: Submit a cover letter and a DEL application to notify us that a new CoC is available. We will obtain the CoC on your behalf from the regulatory authority. You do not need to submit GMP evidence to us for review.
- No CoC from MHRA/VMD: Submit a cover letter, a DEL application and GMP evidence as per GUI-0080 to us for review. If no evidence is available, you may ask us to conduct an inspection or to extend your NERBY date if applicable.
Contact us
If you have questions on the recognition of extrajurisdictional inspections, please email us at foreign.site-etranger@hc-sc.gc.ca.
Page details
- Date modified: