This content is current only at the time of printing. This document was printed on 21 February 2017. A current copy is located at http://apvma.gov.au/node/601
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Conditions set by the APVMA
The approval of an active constituent, label or permit, a manufacturing licence, an agvet product registration or import consent may be subject to conditions that are prescribed by the Agvet Code Regulations or otherwise imposed by the APVMA. We set conditions on approvals to ensure that the objects of the Agvet Code are met.
When you apply for and receive an approval (or licence, registration, permit or import consent) from us it is likely that your approval will contain a number of conditions. These conditions are designed to be consistent, clear, easy to understand and effective in delivering the intended outcome.
Some conditions are established by regulation and form a set of standard conditions that maybe routinely applied. Other conditions may be developed by the APVMA on a case-by-case basis to suit particular circumstances relating to the approved activity.
Standard conditions that will be imposed on an approval, licence or registration by the Agvet Code Regulations may include:
- requiring the active constituent to be manufactured in accordance with the composition and purity entered for the active constituent in the Record and by the manufacturer whose name and site are entered in the record for the active constituent
- requiring the chemical product to contain each of the constituents entered for the chemical product in the Register
- requiring the chemical product to be manufactured in accordance with the particulars entered for the chemical product in the register and manufactured by a manufacturer whose name and site are entered for the chemical product in the register
- requiring that any step in the manufacture of veterinary chemical products take place in licenced premises
- requiring the identifying information for the holder of the approval or registration, and the nominated agent (if any), must be the identifying information for the holder and nominated agent (if any) entered in the Record or Register.
- stipulating the type of container the product must be supplied in
- requiring the label must be attached to the container and contain the relevant particulars for the label
- requiring that the holder of a licence must manufacture the chemical product in accordance with the Manufacturing Principles and the Australian GMP Code
- limiting the quantities used, the area of treated crops or numbers of animals to be treated in the case of a permit
- requiring that records be kept
- undertaking an activity within a specified timeframe.
You should carefully read your approval documents including all terms and conditions attached (if any) to gain a clear understanding of your obligations. We may assess your compliance with the terms of your approval; our compliance strategies include monitoring and enforcement. If you don’t understand or have any questions about how to comply with your conditions you should ask us for assistance. If you think you are going to have difficulty complying with a condition it is important that you let us know as soon as you identify the problem.
Unless a specific exemption, defence or reasonable excuse applies, the Agvet Code makes it unlawful to fail to comply with conditions of an active constituent approval, product registration, permit approval or manufacturing licence.
Non-compliance with a condition of approval will lead to compliance and enforcement action.
An important part of our role is to ensure that agvet chemicals supplied to the marketplace comply with the provisions of the Agvet Code and any conditions we have imposed. This establishes feedback loops and encourages public participation to ensure that the chemical inventory remains safe and effective and that manufacturing activities are producing agvet chemicals of the expected high quality on an ongoing basis. Feedback loops include the Adverse Experience Reporting Program , GMP audits and industry intelligence about non-compliance with manufacturing or supply standards or conditions.
Should we become aware that an agvet chemical poses imminent risk to public health or the environment, or that that conditions we imposed have been breached, we may use legislative provisions to stop the supply of the product. This may involve suspension, cancellation and/or recall of the relevant products. Our aim is to maintain the quality, safety and effectiveness of all products in the marketplace.
Enforcement of conditions
We use a range of administrative and enforcement actions to ensure compliance with conditions of approval or registration, including:
- formal warnings
- issuing an infringement notice
- issuing an enforceable direction
- issuing a substantiation notice
- accepting an enforceable undertaking
- varying conditions placed on an authorisation (approval, registration, permit licence)
- suspending or cancelling an authorisation, or,
- issuing a notice to stop supply or recall products.
Formal warnings about an activity, enforceable directions, enforceable undertakings, or infringement notices (fines) are all mechanisms to provide a proportional and rapid response to certain situations or incidences of non-compliance. It is important to note that due to the unique nature of each non-compliant action or behaviour, the proportional and appropriate response will vary. We are not obliged to use any particular alternative option.