Date of last update: June 10, 2011
Contact Information: Quality and International Assessment Division
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)
March 16, 2000
Ratification of the Agreement
Start of the confidence building exercise
January 1st, 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.
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:
This Agreement does not apply to the following products/processes:
This Agreement does not apply to pre-approval inspections.
At the present time, there is no change to the status of the MRA.