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AGRICULTURAL AND VETERINARY CHEMICALS CODE REGULATIONS (AMENDMENT) 1996 NO.162
EXPLANATORY STATEMENTSTATUTORY RULES 1996 No. 162
Issued by the Authority of the Minister for Primary Industries and Energy
Agricultural And Veterinary Chemicals Code Act 1994
Agricultural and Veterinary Chemicals Code Regulations (Amendment)
Section 6 of the Agricultural and Veterinary Chemicals Code Act 1994 (the Act) provides that the Governor-General may make regulations for the purpose of the Act.
The Agricultural and Veterinary Chemicals Code Bill was passed in March 1994 as part of the package of legislation to implement the National Registration Scheme for agricultural and veterinary chemicals. The Agricultural and Veterinary Chemicals Code Regulations provide necessary support to the Act.
The Agricultural and Veterinary Chemicals Code Regulations currently contain certain provisions relating to the supervision by the National Registration Authority for Agricultural and Veterinary Chemicals (NRA) of the manufacture of veterinary products. The proposed amendments put in place the remainder of a scheme to allow the NRA to supervise the manufacture of veterinary products. This is intended to ensure the adequacy of product quality.
Specifically, the proposed amendments specify with increased precision the scope of the proposed scheme, and set out a range of administrative matters relating to the operation of the scheme, such as arrangements with subcontractors, arrangements when a product is brought within the ambit of the scheme, a licence-holder dies, a business changes ownership, or changes its name.
The proposed amendments also prescribe the annual licence fees, which range from $1500 to $300. 'The fees are commensurate with the NRA's costs in undertaking its duties. A 50% reduction on these fees is prescribed for very small manufacturers whose premises produce less than $50 000 worth of veterinary products each year.
These proposed new arrangements bring Australia into line with other developed countries.
Details of the regulations are as follows:
Regulation 1 provides that the Agricultural and Veterinary Chemicals Code Regulations are amended by the Agricultural and Veterinary Chemicals Code (Amendment) Regulations. The regulations will commence on gazettal.
Regulation 2 exempts any animal skin cleaner or shampoo, externally-applied coat conditioner, equine hoof protectant, sheep branding substance, and certain stockfood additives from the manufacturing provisions of the Act.
Regulation 3
(a) exempts a person who does subcontract packaging and/or labelling, or product testing or analysis for a licensed manufacturer from the provisions of the Act;
(b) provides, when a product ceases to be an exempt product (ie it is brought within the ambit of the manufacturing control arrangements), for the unlicensed status of persons to remain valid until the NRA makes a decision upon their application for a licence,
(c) provides that the legal representative of a deceased licenceholder is exempt from the requirement to hold a licence, and
(d) provides that the purchaser of a licensed manufacturing business is exempt from the requirement to hold a licence provided the NRA is notified of the purchase within 6 weeks; and that the person must comply with the licence as if he or she were the licenceholder; and also apply for a licence.
Regulation 4
(a) requires a licenceholder to effectively supervise a subcontractor,
(b) requires a licenceholder to keep a record of complaints and product failures;
(c) requires a licenceholder to inform the NRA of any name changes involving the licenceholder; and
(d) requires a licenceholder who is a company to inform the NRA if its status changes so that it is in liquidation or receivership, or has a receiver/manager appointed.
Regulation 5 prescribes the fees for the issue of a manufacturing licence. The fees range from $1500 to $300 per annum, with a provision that half the fees for any year will be refunded by the NRA if the manufacturer supplies evidence that the wholesale value of veterinary chemicals manufactured at that premises was less than $50 000.