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Australia, Canada

Mutual Recognition Arrangement on Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification between the Government of Australia and the Government of Canada

This Agreement covers medicinal products Good Manufacturing Practice (GMP) inspection and certification.

The Agreement provides for the mutual recognition of the certification and acceptance of Certificates of Good Manufacturing Practice (GMP) of manufacturers of medicines issued by the Therapeutic Goods Administration, Department of Health and Ageing of Australia and the Health Products Food Branch of Canada. ;
The Agreement will allow Australia and Canada to recognize and accept each other's technical competence to certify products for compliance with their domestic standards and regulatory requirements. In addition, it will also allow the manufacturer's certification of the specifications of each batch of medicinal products to be recognized by the other party without reanalysis at import. ;

The Agreement is a single-sector, bilateral Government to Government Agreement covering GMP inspection and certification of medicinal products. A Joint Sectoral Group, established under the Agreement, provides for the effective functioning of the Agreement. In particular, it may consider any matters relating to amending the Agreement, developing, managing and assessing the Confidence Building Program, resolving any questions or differences relating to interpretation, operation or application of the Agreement.