14Overseas manufacturers

14 Overseas manufacturers

(1) For a veterinary chemical product, the application must contain, or be accompanied by, 1 or more of the following in relation to each person who performs a step in the manufacture of the product outside Australia: (a) an original or notarised certificate of good manufacturing practice, issued by an authority recognised by the APVMA, that the performance of that step complies 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.