This content is current only at the time of printing. This document was printed on 22 April 2019. A current copy is located at https://apvma.gov.au/node/1075
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Overseas veterinary chemical product manufacturers are not licensed by the APVMA. In order to supply an intermediate or finished product to Australia they need to comply with standards equivalent to those applied to Australian manufacturers.
Overseas sites need to comply with equivalent standards for their products to be registered in Australia.
Registrants of intermediate or finished products manufactured overseas are required to provide acceptable evidence of overseas GMP compliance. Conditions of registration require the registrant to ensure all sites involved in any step of manufacture—whether in Australia or overseas—maintain compliance with GMP. Registrants also need to ensure appropriate evidence of compliance is kept and submitted to the APVMA on request.