About Compliance
Before an agricultural or veterinary chemical product can be legally imported, supplied, sold or used in Australia, it must be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Part of the APVMA's; role and responsibility is to monitor and enforce compliance with the Agvet Code up to and including the point of retail sale. The APVMA also works closely with State and Territory departments to ensure there is effective coordination and communication of compliance efforts.
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How is Compliance Managed?
Compliance involves the assessment of risk and the application of appropriate enforcement responses to alleged breaches of the Agvet Code reported to the APVMA or identified via the APVMA's monitoring function. Investigations may relate to unregistered products, supply of restricted products to unauthorised users, unapproved labels, claims in advertising, or formulations and active constituents which do not conform with standards.
The standards set in the registration process are enforced in the marketplace using a range of compliance strategies applied at the relevant points in the supply chain, that extend from the import barrier to retail premises. The APVMA employs three distinctive strategies in its efforts to ensure products comply with the Agvet Code.
The strategies are:
- Prevention - Aims at promoting greater awareness and understanding of registration and compliance requirements. This is achieved by educating stakeholders (including registrants, manufacturers and suppliers), on their roles and responsibilities. The APVMA also works with the Australian Customs Service to stop the illegal importation of agvet chemicals
- Quality facilitation - Is achieved through the publication of a wide range of standards and guidelines, such as the registration guidelines, the product labeling code and product recall guidelines. The APVMA has implemented a scheme to licence all manufacturers of veterinary chemical products in an effort to achieve high standards of quality and facilitate exports, and encourage the reporting of any adverse experiences resulting from their use. Registrants have an obligation to report adverse experiences in the interests of public health and safety, and
- Monitoring and enforcement - The APVMA actively investigates alleged breaches and implements risk based enforcement strategies, such as recalls, warnings and injunctions.
Benefits of Compliance
Agricultural and veterinary chemicals are vital to quality food and fibre production. Australia's primary production is worth an estimated $30 billion a year with an export value of over $25 billion.
Registered agricultural and veterinary chemical products help ensure this level of production can be maintained. The majority of primary producers rely on agricultural and veterinary chemicals to protect their crops and animals from disease and pests.
By choosing a registered chemical, you know the APVMA has assessed it against today's exacting standards.
Consequences of Non-compliance
Illegal supply and use of unregistered agvet chemical products carries a heavy penalty. Not only could using an unregistered chemical product jeopardise the user, their family and their livelihood, but it could affect Australia's trade with other nations.
Consequences of using unregistered chemical products may include:
- personal safety
- crop and herd damage or loss
- economic loss
- occupational health and safety hazards
- threats to public health
- environmental damage, and
- international trade losses.
Cases of Non-compliance
When complaints of non-compliance are received, the APVMA first checks the validity of the complaint. If a breach is confirmed the APVMA may apply one or a combination of enforcement strategies. These include official warnings, requests or directives for product recall/re-labeling or the matter may be referred to the Commonwealth Director of Public Prosecutions (DPP) for prosecution.
The APVMA has successfully prosecuted individuals and companies for contravention of the legislation. Offences under the Agvet Code carry penalties of up to $33,000 for individuals and $165,000 for companies.
Advertising
The Agvet Code provides controls for the advertising of unregistered chemical products as well as active constituents for chemical products. The provisions of the Agvet Code create offences where any advertising offers to sell or makes an invitation to buy products that are not registered. This advertising could be in a variety of formats including magazines, newspapers, pamphlets, handouts, electronic media including the internet.
It is also an offence to make claims that are inconsistent with any instruction on the approved label or that are false or misleading. However, the APVMA will only respond to advertising complaints which reveal an offence under the Agvet Code and involve significant harm to human or animal health, environmental harm or impact to trade.
The Agvet Code provides a penalty for advertising offences of up to $33,000 for an individual or up to $165,000 for a company. The offences apply equally to the person who commissions the advertisement as well as the publisher of the advertisement.
The APVMA, however, doesn't investigate all complaints. For more information, please see the operational notice on complaints about advertising.
Please read the advertising guidelines.
Contact
To discuss your responsibilities under the Agvet Code or for more information on the APVMA's role in Quality Assurance and Compliance, contact:
- Program Manager - Regulatory Strategy and Compliance T: +61 2 6210 4791
- Manager - Compliance T: +61 2 6210 4796