This content is current only at the time of printing. This document was printed on 24 June 2021. A current copy is located at http://www.plural-consulting.com/node/19656
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Manufacturers’ Licensing Scheme
The Australian Pesticides and Veterinary Medicines Authority (APVMA) administers the Manufacturers’ Licensing Scheme to manage the issue of licences to Australian based sites to manufacture veterinary chemical products and the ongoing maintenance of these licences.
A licence must be held regardless of whether the product is to be supplied within Australia or exported.
As part of our assessments for product registration and permits, we assess the manufacturers nominated by the applicant to ensure they:
- are licensed to manufacture the product
- that the licence includes the nominated steps of manufacture.
Manufacturers seeking to obtain or vary a licence must apply to the APVMA for approval and pay the prescribed fees. We must be satisfied that the manufacturing facility is suitable for the activities to be conducted and that the applicant is able to comply with the Manufacturing Principles and Good Manufacturing Practice (GMP) Code before we can issue or change a licence.
In most cases, we base our decision on audit reports provided to support the application.
In many cases, a manufacturer who already holds a licence or certificate issued by the Therapeutic Goods Administration (TGA) or the National Association of Testing Authorities (NATA) can use it to support an application to the APVMA for a licence to manufacture.
Once a licence is issued it remains in force unless it is suspended or cancelled. The licence is subject to certain statutory conditions and any other conditions that we believe necessary and include in the licence (or in schedules to the licence).