Mutual Recognition Agreement between Canada and Australia

Date of last update: February 4, 2021

Contact Information: Mutual Recognition Agreement (MRA) and International Affairs Unit

Text of the Agreement

The text of the Agreement can be found at the Global Affairs Canada (GAC) website. In the relevant document, refer to the section entitled "Sectoral Annex on Medicinal Products / Drug Good Manufacturing Practices (GMP) Compliance Certification".

Text of the Canada-Australia Mutual Recognition Agreement
Global Affairs Canada (GAC)

On this page:

• Key dates
• Scope - Product Coverage
• Regulatory Authorities Involved
• Status summary - Update

Key Dates

• March 16, 2000
  Ratification of the Agreement
• October 2001
  Start of the confidence building exercise
• January 1^st, 2006
  Start of operational phase
• November 1st, 2018
  Inclusion of Active Pharmaceutical Ingredients (API) in the operational scope of the MRA

Operational Phase

Once a Regulatory Authority’s GMP Compliance Programme is found equivalent based on the Mutual Recognition Agreement (MRA) evaluation process, the regulatory authority is considered to be in the Operational Phase of the MRA, meaning that the exchange of Certificates of Compliance and the information on the Two-Way Alert System is shared between the regulatory authority and Canada.

Canadian companies exporting drugs/medicinal products including API to Australia that fall within the scope of the MRA and that are manufactured within Canada may benefit from specified GMP exemptions provided by the MRA.

Canadian companies importing drugs/medicinal products including API that fall within the scope of the MRA and that are manufactured within Australia may benefit from specified GMP exemptions provided by the MRA as listed in the Canadian Good Manufacturing Practices guide for drug products (GUI-0001).

Scope - Product Coverage

Human medicinal / drug products.

The list of products covered, as written in the Agreement, is given below:

• human pharmaceuticals such as prescription and non-prescription medicines / drugs and medical gases;
• human biologicals including vaccines, immunologicals, and biotherapeutics; and
• human radiopharmaceuticals.

This Agreement does not apply to the following products/processes:

• blood and blood components;
• tissues and organs of animal or human origin;
• official batch release of biologicals;
• stable medicines/drugs derived from human blood or plasma; or
• veterinary pharmaceuticals, including sterile and non-sterile veterinary pharmaceuticals.

This Agreement does not apply to pre-approval inspections.

Clarifications:

• human biologicals including vaccines, immunologicals, and biotherapeutics / official batch release of biologicals (Note: the MRA covers GMP evidence for manufacturing sites of human biologicals, it does not address the Canadian requirements for lot-to-lot release of these products as set out under Section C.04.015 of the Food and Drug Regulations).

Definite exclusions:

• this Agreement does not apply to Natural Health Products.

Regulatory Authority Involved

List of Australian Regulatory Authorities

Status Summary - Update

Common Statement regarding inclusion of Active Pharmaceutical Ingredient in Australia-Canada Mutual Recognition Agreement (as of November 1, 2018)

Background

On November 8, 2013, new regulatory amendments for mandatory Good Manufacturing Practices (GMP) of Active Pharmaceutical Ingredients (API) intended for use in human drugs came into force in Canada.  The implementation of these regulatory amendments under the Food and Drug Regulations enable Health Canada (HC) to include APIs under the operational scope of its existing Mutual Recognition Agreements (MRAs).

In Australia, manufacturers of APIs are regulated under the Therapeutic Goods Act 1989 (‘the Act’) and the Therapeutic Goods Regulations 1990 (‘the Regulations’). API manufacturers located in Australia are required to hold a GMP licence that authorizes the manufacture of APIs (unless specifically exempt under the Regulations).

As of  November 1, 2018, Health Canada and the Therapeutic Goods Administration (TGA) of Australia concluded an agreement to include APIs under the scope of the Mutual Recognition Agreement On Conformity Assessment In Relation To Medicines Good Manufacturing Practice Inspection And Certification Between The Government Of Canada And The Government Of Australia.  Therefore, Health Canada accepts GMP Certificates of Compliance, issued by the TGA, for APIs fabricated/manufactured in Australia as evidence of compliance to GMP. 

Benefits to the MRA Agreement

Stakeholders from Canada will benefit from the exchange of GMP Certificates of Compliance between TGA and Canada, therefore reducing regulatory burden to obtain information from their foreign buildings.

No re-control exemptions upon import

The GMP requirements described in the regulations of respective countries must be met.  Health Canada’s GMP Requirements according to C.02.009 Raw materials testing, require the Finished Dosage Form (FDF) manufacturer to fully test starting raw material upon receipt or perform periodic confirmatory testing when there is a certification programme in place as long as requirements of C.02.010 are met.   This will continue to be applicable to APIs regardless of the origin of import.  As such there will be no re-control exemptions upon import.