MRA with Australia

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EC - Australia MRA

The Sectoral Annex on Medicinal products GMP Inspection and Batch Certification to the MRA in relation to conformity assessment, certificates and markings between the European Community and Australia (OJ L229 on 17/08/1998) are in operation since 1 January 1999 for human and 1 June 2001 for veterinary medicinal products.

The agreement is based on exchange of certificates of GMP compliance for manufacturers and batch certificates. The contents of these certificates have been agreed with Australia and are available on this website. A Two Way Alert System based on the European system is in operation.

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