. /.  WORLD TRADE  
ORGANIZATION  G/TBT/10.7/N/48 
10 January 2006 
 (06-0097) 
Committee on Technical Barriers to Trade Original:   English 
 
 
AGREEMENT REACHED BY A MEMBER WITH ANOTHER COUNTRY OR COUNTRIES 
ON ISSUES RELATED TO TECHNICAL REGULATIONS, STANDARDS 
OR CONFORMITY ASSESSMENT PROCEDURES 
 
Notification  
 
 
 Under Article 10.7 of the Agreement "Whenever a Member has reached an agreement with any other country or countries on issues related to  technical regulations, standards or conformity 
assessment procedures which may have a significant effect on trade, at least one Member party to the agreement shall notify other Members through the Secr etariat of the products to be covered by the 
agreement and include a brief description of th e agreement."  The following notification under 
Article  10.7 has been received.   
1. Member notifying:  AUSTRALIA AND CANADA
 
 
2. Title of the bilateral or plurilateral Agreement:  Mutual Recognition Arrangement on 
Conformity Assessment in Relation to Me dicines Good Manufacturing Practice Inspection 
and Certification between the Government of  Australia and the Government of Canada  
3. Parties to the Agreement:  The Government of Australia and the Government of 
 Canada  
4. Date of entry into force of the Agreement:  1 January 2006 (first day of the second 
 month following the date on which the Parties have exchanged notes).   
5. Products covered (HS or CCCN where applicable, otherwise national tariff heading): 
This Agreement covers medi cinal products Good Manufacturi ng Practice (GMP) inspection 
and certification.  
6. Subject matter covered by the Agreement  (technical regulations, standards or 
conformity assessment procedures):  The Agreement provides for the mutual recognition 
of the certification and acceptance of Certifi cates of Good Manufacturing Practice (GMP) of 
manufacturers of medicines issued by the Ther apeutic 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 co mpliance 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.  G/TBT/10.7/N/48 
Page 2  
 
7. Brief description of the Agreement:  The Agreement is a single-sector, bilateral 
Government to Government Agreement c overing 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, devel oping, managing and assessing the Confidence 
Building Program, resolving any questions or  differences relating to interpretation, 
operation or application of the Agreement. 
8. Further information available from:   
 
Australia 
Director Office of Devices, Blood and Tissues Therapeutic Goods Administration PO Box 100 
Woden ACT 2606 
cab.Medical.device.information@health.gov.au Canada 
Attention: Michelle Boudreau HEALTH PRODUCTS AND 
FOOD BRANCH 
Director General's Office  
250, Lanark Ave 
Graham Spry Building, 3
rd Floor 
Ottawa, Ontario K1A 0K9 A.l. 2003A E-mail: michelle_boudreau@hc-
sc.gc.ca