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New statutory conditions that apply to existing and new label approvals

Recent amendments to the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations) developed by the Department of Agriculture, Fisheries and Forestry now impose several new conditions on all label approvals. These amendments came into effect on 18 March 2011 and apply to all existing approved labels, not just to those approved after this date. These changes complement amendments made to the Agricultural and Veterinary Chemicals Code Act 1994 in 2010 that took effect on 15 July 2010 and changed the way APVMA approves labels.

This page summarises the requirements imposed by these conditions. Full details on these regulations can be found in 18B to 18I of the Regulations (external site).

When preparing labels for use in the marketplace (Marketed Product Labels - MPLs), registrants of agvet chemical products are legally required to ensure that the label:

  • is attached to the container before the supply of the product (18C); and
  • states the relevant particulars for the label, the batch number, and (as applicable) the manufacture date of the product and/or the expiry date (18D); and
  • complies with the relevant APVMA labelling code depending on whether the product is a veterinary or agricultural chemical product (18E). The APVMA will soon make a Labelling Standard under regulation 18A, which in conjunction with a new Best Practice Guide will replace the existing labelling Codes

Registrants must also ensure that the label does not:

  • contain information contrary to that required for the label (18D(2)); or
  • contain misleading or deceptive information about a particular on the label or about the use, safety, environmental impact, or efficacy of the chemical product (18F).

Consistent with these requirements:

  • information that the APVMA requires must not be altered, defaced, obliterated, obscured or destroyed (18D(3)); and
  • information must not accompany or be placed on the container if the information negates or varies, or qualifies or minimises the substance, purport or effect of information required to be stated on the label (18F); and
  • registrants must not make any claim about registered chemical products that are inconsistent with an instruction on the label for a container for the chemical product (18G).

The Regulations also impose record keeping obligations, including that registrants must:

  • retain a copy of each form of a label and record information about the use of the label, including the batch number to which the label relates and the day the container on which the label is attached is first released for supply (18H); and
  • provide the copy of a form of the label and the information about its use, as required to be recorded by above, to the APVMA on written request. The label and information must be provided to the APVMA within 10 days, or earlier if the APVMA believes it is necessary to receive the label or information to prevent imminent risk to public health or occupational health or safety (18I).

Registrants must observe all relevant conditions when preparing Marketed Product Labels (MPLs) as the label approval is granted subject to those conditions. As the APVMA no longer assesses or approves MPLs it is beyond its scope of operation to advise registrants on whether their MPLs comply with the conditions of label approval in its pre-market assessment. This is the registrant’s responsibility. However the APVMA will check MPLs at retail outlets and through targeted audits. Non-compliance with these statutory conditions of approval may result in the approval being suspended or cancelled.

The APVMA advises that all registrants refer to the Regulations, particularly Regulations 18B to 18I, to ensure that the MPLs for which they are responsible are compliant.

Contact

+61 2 6210 4871
communications@apvma.gov.au

Last updated on 11 April, 2011
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