29Overseas manufacturers

29 Overseas manufacturers

For a veterinary chemical product the manufacturers of which would change if the particulars or conditions are varied in accordance with the application, the application must, for each person who manufactures the chemical product outside Australia, contain or be accompanied by 1 or more of the following: (a) an original or notarised certificate of good manufacturing practice, issued by an authority recognised by the APVMA, that all steps of the manufacture undertaken at that site comply with the manufacturing principles or a comparable good manufacturing practice code; (b) an original or notarised copy of an audit report on good manufacturing practice from an auditor from an authority recognised by the APVMA, and evidence that any identified non-conformances have been addressed and that the person’s facility complies with the manufacturing principles or a comparable good manufacturing practice code; (c) other evidence demonstrating the person’s good manufacturing practice. (2) A document referred to in paragraph (1)(a) or (b) may be provided electronically, but if it is, the applicant must retain a hard copy of the document for provision upon the APVMA’s request.