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Agricultural and Veterinary Chemicals Code (Manufacturing Principles) Determination 2014
Agricultural and Veterinary Chemicals Code

I, Kareena Arthy, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority:

a)      make this Determination for the purposes of subsection 23(1) of the Agricultural and Veterinary Chemicals Act 1994; and
b)     repeal the Agricultural and Veterinary Chemicals Instrument No. 1 (Manufacturing Principles) 2007 with effect from the commencement of this Determination.

Kareena Arthy
Chief Executive Officer

Dated this 25th day of  June 2014

Part 1  Preliminary
1 Name of Standard
  This Determination is the Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination 2014.
2 Commencement
  This Determination commences on the commencement of Schedules 1 to 6 to the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013.
3 Object
  The object of this Determination is to set out written principles to be observed in the manufacture of veterinary chemical products, unless the products are exempt from the requirement to be manufactured in licensed facilities under the Agvet Regulations.
4 Interpretation
 (1) Unless the contrary intention appears, an expression used in the Agvet Code or the Agvet Regulations and in this Determination has the same meaning in this Determination as in the Agvet Code or the Agvet Regulations.
 (2) In this Determination, unless the contrary intention appears:
  Agvet Code means the Agricultural and Veterinary Chemicals Code, scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.
  Agvet Regulations means the Agricultural and Veterinary Chemicals Code Regulations 1995.
  Code of Good Manufacturing Practice means the Australian Code of Good Manufacturing Practice for Veterinary Chemical Products (including its Annexes) published by the Australian Pesticides and Veterinary Medicines Authority on 29 March 2007.
  specified biological process means a process of manufacture of a veterinary chemical product involving one or more of the following:
          (a)   microbial, cell or tissue culture, including fermentation;
          (b)   extraction from biological tissues, including animal and plant tissues;
          (c)   derivatives from blood and body fluids;
          (d)   genetic manipulation, including recombinant DNA and hybridoma techniques;
          (e)   biotechnological processes;
          (f)    propagation in embryos or animals;
          (g)   formation or isolation of protein fragments or their derivatives.
  relevant approval means an administrative decision permitting the supply of a chemical product, whether the decision is made in Australia or overseas, and whether it is made by the APVMA or an overseas authority.
Part 2 Manufacturing principles for veterinary chemical products
5 Compliance with Code of Good Manufacturing Practice
  Subject to this Determination, veterinary chemical products must be manufactured in compliance with the Code of Good Manufacturing Practice.
6 Quality management
 (1) Manufacturers of veterinary chemical products must have in place a quality assurance system to ensure that finished products are fit for their intended use, are manufactured in accordance with the