Mutual Recognition Agreement between Canada and Australia

Date of last update: June 10, 2011

Contact Information: Quality and International Assessment Division

Text of the Agreement

The text of the Agreement can be found at the Canadian Department of Foreign Affairs and International Trade (DFAIT) 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
 Canadian Department of Foreign Affairs and International Trade (DFAIT)

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

Canadian companies exporting drugs/medicinal products 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 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 GMP Guideline.

Scope - Product Coverage

Human medicinal / drug products.

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

This Agreement applies to all medicines which in Australia and/or Canada are subject to a GMP compliance program. These include:

• 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

At the present time, there is no change to the status of the MRA.