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 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.\

Manufacturing Quality and Licensing Section statistics, CY2019 (1 January to 18 September 2019)

Out of 64 new audits initiated in the current calendar year; 18 have been closed. Below is the graph showing MQL performance in terms of time taken to close out the audits.

The time (in months) is calculated from the time the complete audit report is received by the APVMA and when our final risk assessment and notice of audit closure is issued to the manufacturer.

2019 Audit Closure time

MQL have issued 50 export certificates between 1 January and 18 September 2019

Certificate type

Closed

Under review

S69D—Export and Manufacture

34

Nil

S70—Manufacture

16

Nil

Total

50

Nil

TGA MRA Certificates

Issued

New

1

Extended

3

Total

4

 

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