How can I obtain recognition of the GMP compliance of an overseas manufacturer?
If evidence is submitted with a product application, the evidence of GMP compliance will normally be assessed by the APVMA’s GMP Section as part of the screening process. If further information is required, this will be requested. If the submitted evidence appears complete but a more detailed assessment is required (such as evaluation of an audit report), that assessment will be conducted as part of the evaluation process. The time period involved in resolving GMP compliance issues can be lengthy, particularly when audits are undertaken. Note: Applicants are encouraged to submit evidence to the GMP Section prior to submitting a product application, so that GMP issues do not delay the product application process. A facility will only be recognised as GMP compliant for the specific types of products and steps of manufacture described in the evidence supplied. Conditions of registration will require the registrant to ensure that this GMP compliance is maintained and that evidence of this
