Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes after March 31, 2021

Drug Establishment Licensing Bulletin 111, April 22, 2021

On this page

• Why Canada is recognizing extra-jurisdictional GMP inspections
• Certificates of GMP compliance
• How to submit DEL applications
• How the CoC will be reviewed

Canada and the European Union (EU) officially recognized good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions as of April 1, 2021. The extra-jurisdictional inspections are outlined in the Comprehensive Economic and Trade Agreement (CETA)’s protocol on pharmaceuticals. This protocol is known as the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products.

Why Canada is recognizing extra-jurisdictional GMP inspections

The expanded scope will enhance cooperation and regulatory alignment between Canada and the EU. It will also reduce the regulatory burden for Canadian importers. Health Canada and the equivalent EU regulatory authority will be able to exchange GMP evidence directly.

Certificates of GMP compliance

A regulatory authority issues a certificate of GMP compliance (CoC) attesting that a facility is complying with the GMP requirements.

Currently, the CETA protocol on pharmaceuticals covers the exchange of a CoC for products in finished dosage form for inspections conducted within Canada and EU countries.

CoCs will continue to be exchanged directly between Health Canada and the equivalent EU regulatory authorities under the CETA protocol. See Annex 1 of the CETA protocol for pharmaceutical products included in the operational scope of the protocol.

Active pharmaceutical ingredient (API) inspections continue to be outside of the operational scope of the CETA protocol. They are not covered in the exchange of extra-jurisdictional CoCs.

Note: The GMP requirements outlined in the Food and Drug Regulations (FDR) must continue to be met. Health Canada’s GMP requirements continue to apply, including section C.02.019 of the FDR for finished product testing requirements. See the Good manufacturing practices guide for drug products (GUI-0001). Therefore, there are no GMP exemptions for imported finished dosage form products from these foreign buildings.

How to submit DEL applications

Extra-jurisdictional inspections conducted on or after April 1, 2021, are eligible for extra-jurisdictional CoCs. This means you may add or maintain a foreign building on your drug establishment licence (DEL) by submitting a request to Health Canada to obtain the extra-jurisdictional CoC from the equivalent EU regulatory authority. You do not need to submit the full GMP evidence to us for review.

Please specify in your cover letter and in the Drug Establishment Licence Application Form (FRM-0033) that an extra-jurisdictional CoC is available for the foreign building.

For further instructions, please email: Hc.DEL.Questions-LEPPP.SC@canada.ca.

It’s your responsibility to ensure that the CoC supports the activities, categories and dosage forms on FRM-0033. Failing to do so will cause your application to be rejected, as outlined in the guidance document Management of applications and performance for drug establishment licences (GUI-0127).

Note: If any of your foreign buildings have a non-compliant rating (previously determined by Health Canada), you must submit full GMP evidence for a full review. In this scenario, applications submitted for CoC review will be rejected as the evidence does not meet the requirements. See the guidance document How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).

How the CoC will be reviewed

Health Canada will compare the information on the CoC issued by the equivalent EU regulatory authority to the scope of the DEL application. The foreign building will stay on or be added to the Foreign Building Annex of the importer's DEL if the scope of the CoC:

• is within the CETA protocol on pharmaceuticals and
• includes the activities, categories and dosage forms requested by the applicant

New evidence required by (NERBY date)

Currently, foreign buildings do not have a NERBY date if:

• they are located in a mutually recognized country and
• the activities, categories and dosage forms are covered by the mutual recognition agreements

Health Canada will, however, assign a NERBY for CoCs received for extra-jurisdictional inspections conducted by the equivalent EU regulatory authority. Importers are responsible for submitting an application before the NERBY date to maintain the foreign building on the Foreign Building Annex.

Health Canada will monitor the implementation of the mutual recognition of GMP extra-jurisdictional inspections. We will make adjustments and communicate to DEL holders if necessary.

More information on this extra-jurisdictional initiative is available on the Mutual Recognition Agreement website.