Document ID: chunk:federal_register_of_legislation:F2020C00810:reg:14
Version: federal_register_of_legislation:F2020C00810
Segment Type: reg
Provision Reference: reg 14
Character Range: 22331–23436

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.