New memorandum of understanding with Australia

Drug Establishment Licensing Bulletin 170, March 1, 2024

On this page

• Introduction
• About the new MOU with Australia
• How this change affects you
• How to apply
• If there's no valid certificate of compliance
• Contact us

Introduction

There is a new memorandum of understanding (MOU) between Canada and Australia.

As of March 1, 2024, Canada and Australia will officially recognize good manufacturing practices (GMP) inspections conducted outside of their respective jurisdictions (known as extra-jurisdictional inspections).

Remote and hybrid inspections are not covered under this MOU. For foreign inspections, remote and hybrid inspections are defined as:

• Remote inspections using technology to communicate, share and review documentation without the need for an on-site visit
• Hybrid inspections consisting of both remote and on-site inspections involving a minimum of 2 regulators inspecting the same site (1 on-site and 1 remotely)

This expanded scope will:

• enhance cooperation and regulatory alignment between Canada and Australia
• reduce the regulatory burden for Canadian importers
  • Canadian importers will no longer need to submit GMP evidence to Health Canada when there's a valid extra-jurisdictional certificate of (GMP) compliance for requested activities, dosage forms and/or drug categories

A certificate of compliance will be exchanged directly between Health Canada and the Therapeutic Goods Administration (TGA) in Australia.

This extra-jurisdictional recognition is in addition to those that Health Canada announced earlier with the European Union (EU) and United Kingdom:

• Canada and EU recognize good manufacturing practices extra-jurisdictional inspection outcomes after March 31, 2021
• Canada and EU recognize GMP extra-jurisdictional inspection outcomes before April 1, 2021
• Canada and the United Kingdom officially recognize extra-jurisdictional good manufacturing practices inspections

About the new MOU with Australia

Before March 1, 2024, Canada and Australia only exchanged certificates of compliance if inspections were conducted within our jurisdictions and fell within the Mutual Recognition Agreement (MRA). For example:

• Canada exchanged with Australia for inspections conducted in Canada
• Australia exchanged with Canada for inspections conducted in Australia

Importers did not have to submit a drug establishment licence (DEL) application to maintain the foreign building on their licence if:

• the building held a valid certificate and
• the certificate supported the compliance of activities, drug categories and dosage forms requested on the application form

Effective March 1, 2024, Canada and Australia will exchange these certificates for inspections conducted in and outside their respective jurisdictions as long as the new or previously issued CoCs are within:

• the validity period listed on the certificate and
• the operational scope of the agreement and MOU

Mutual recognition agreement between Canada and Australia

How this change affects you

If you're importing finished dosage form products

To import human finished dosage form (FDF) products from a foreign building that is not located in Australia but has been inspected by the TGA, you may not need to submit GMP evidence with your DEL application if the certificate of compliance:

• is within the scope of the MOU
• supports the activities, categories and dosage forms you requested and
• the issued date is still valid

FDF activities also include:

• release testing of non-sterile active pharmaceutical ingredients (APIs)
• the fabrication, packaging, labelling and testing of sterile APIs and sterile API intermediates

We will ask for an extra-jurisdictional certificate of compliance from the TGA once we have received your application. We will then compare the information on the certificate with your DEL application.

We will add the foreign building on your Foreign Building Annex and assign a date for new evidence required (NERBY date) to the foreign building if we find the foreign building is:

• in compliance
• the certificate supports the activities, categories and dosage forms you requested
• the date the certificate was issued is valid

Once the foreign building is listed on your DEL Foreign Building Annex, you may start importing from that site. A NERBY date will be assigned.

You must renew your application and provide the appropriate GMP evidence, if applicable, by the assigned NERBY date to:

• keep the foreign building on your DEL Foreign Building Annex
• continue to import from that foreign building

If you're importing API products

APIs are within the operational scope of the mutual recognition agreement between Canada and Australia. However, a NERBY date is not assigned to foreign buildings listed on an API foreign building annex. There are no changes to this process at this time.

Please refer to the following guidance document:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

Important information to know

Although you're not required to submit GMP evidence to Health Canada, you must maintain a copy of the GMP evidence onsite.

There are also no GMP exemptions for APIs and FDF products imported from extra-jurisdictional foreign buildings inspected by the TGA.

Note: The GMP requirements outlined in the Food and Drug Regulations (regulations) must continue to be met. This includes requirements set out in sections C.02.009, C.02.010 and C.02.019 for raw material and finished product testing.

Learn more about the GMP requirements in the regulations:

• Good manufacturing practices guide for drug products (GUI-0001)

How to apply

It's up to you to ensure that your certificate of compliance from the TGA:

• is valid
• supports the activities, categories and dosage forms requested on FRM-0033

If Health Canada had already assigned a non-compliant rating to your foreign building, you will not be able to qualify for an extra-jurisdictional certificate of compliance review. Instead, you will have to submit GMP evidence for review.

Please refer to the following guidance document:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

To verify if your foreign building has a compliant or non-compliant rating, please consult:

• Drug and Health Products Inspections Online Database (DHPID)

Adding or amending a foreign building inspected by the TGA to your DEL Foreign Building Annex

To add or amend a foreign building to your DEL that is outside Australia's jurisdiction but inspected by the TGA, please include the following information in your DEL application:

• a cover letter
  • indicate that the TGA has conducted a GMP inspection and a valid EJ CoC, covering your requested activities, categories and dosage forms, is available for the foreign building
• a completed FRM-0033

Note: You do not need to submit GMP evidence to us. We will obtain the certificate of compliance from the regulatory authority on your behalf.

Maintaining a foreign building on your DEL Foreign Building Annex

To maintain the foreign building on your DEL Foreign Building Annex, you must submit a renewal application by your NERBY date.

If you have a new extra-jurisdictional certificate of compliance from the TGA (or other applicable MRA partner), please include the following information in your DEL application:

• a cover letter
  • indicate that the TGA (or other MRA partner) has a new extra-jurisdictional certificate of compliance that covers your requested activities, categories and dosage forms for the foreign building
• a completed FRM-0033

Note: You do not need to submit GMP evidence to us. We will obtain the certificate of compliance from the regulatory authority on your behalf.

If a new certificate isn't available from the TGA (or other MRA partners eligible for extra-jurisdictional certificate of compliance exchange) but another regulatory agency has inspected the foreign building, you must submit GMP evidence.

You must also submit a cover letter and a completed FRM-0033.

If there's no new GMP evidence available, refer to the following guidance:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

How to fill out FRM-0033

Drug establishment licence application (FRM-0033)

Step 1:

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 - Alternative text

A form showing where to indicate the foreign company name and address, and if building in a country with a Mutual Recognition Agreement.

Step 2:

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, TGA).

Image 2 - Alternative text

A form showing what to check off if a regulatory authority for a site outside its jurisdiction.

If there's no valid certificate of compliance

It's up to you to ensure that there's a valid certificate of compliance before you ask for an extra-jurisdictional certificate of compliance review.

If you don't have a valid certificate or the certificate doesn't support the activities, categories and dosage forms requested, you may have to re-submit your application.

Learn more:

• How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

Contact us

For more information on extra-jurisdictional inspections:

• Mutual Recognition Agreement website

To ask us about extra-jurisdictional inspections, please email us at foreign.site-etranger@hc-sc.gc.ca.

To ask us about DEL applications, please email us at del.questions-leppp@hc-sc.gc.ca.