This content is current only at the time of printing. This document was printed on 19 April 2021. A current copy is located at https://apvma.gov.au/node/1086
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Manufacturing
Manufacturing
The Agvet Code requires all veterinary chemical products manufactured within Australia to be manufactured in licensed premises. This is unless those chemical products are listed, reserved or exempt.
Manufacturers’ Licensing Scheme
The APVMA administers the Manufacturers’ Licensing Scheme to manage the issue of licences to manufacture veterinary chemical products and the ongoing maintenance of these licences. The list of licensed Australian manufacturers of veterinary medicines includes the authorised licence category and steps of manufacture.
The APVMA defines the term ‘manufacturing’ as any step in the creation, production or distribution process of veterinary chemical products. This may include, but not limited to:
- quality assurance (QA) of raw materials and/or packaging materials
- formulation and blending
- assembling
- packaging
- labelling
- storage associated with the manufacturing process
- sterilising and microbiological reduction
- analysis and testing
- release from manufacture for supply or sale.
The APVMA operates an Overseas GMP Scheme, which applies to overseas manufacturers of intermediate or finished products supplied into Australia. This means products manufactured outside Australia are required to comply with GMP standards equivalent to those applied to Australian manufacturers.
Assessment of compliance with GMP
|
Timeframe after final audit report received by APVMA |
FY 2019–20 |
FY 2020–21 (through Q2)
|
|---|---|---|
|
<3 months |
33 |
20 |
|
3-6 months |
2 |
7 |
|
6–9 months |
2 |
0 |
|
>9 months |
0 |
0 |
|
Total |
37 |
27 |
Certificates
|
Certificate type |
FY 2019–20 |
FY 2020–21 (through Q2) |
|---|---|---|
|
Export |
63 |
51 |
|
EC-MRA |
10 |
11 |
|
Total |
73 |
62 |