For a long time, there have been difficulties in the implementation of the Mutual Recognition Agreement on inspections between the EU and Canada.

During the Transition Period, the Canadians had encountered problems in the GMP supervision of a European country. Now it has been agreed for the MRA to start its operational phase on 1 February 2003. The MRA covers human and veterinary medicinal products, but does not refer to pre-approval inspections. The Agreement is based on the exchange of certificates of GMP compliance and batch certificates.

The EMEA Status Report of January 2003 also contains information concerning the other MRAs. Please click here in order to read the document.

If you would like to read the most important decisions regarding the EU/Canada MRA, please click here.

Author:
Oliver Schmidt
CONCEPT HEIDELBERG