Overview of agvet chemical regulation

The regulatory framework for managing agricultural and veterinary (agvet) chemicals in Australia is collectively referred to as the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS). The NRS is a partnership between the Commonwealth and the states and territories, with a shared division of responsibilities.

The APVMA administers the NRS in partnership with state and territory government agencies—in collaboration with other Commonwealth agencies, law enforcement and the judiciary.

1. Applications

Individuals, companies, organisations, trade associations and other groups can submit an online application to the APVMA to:

• approve a new agvet chemical (active constituent)—or vary one already approved
• register a new agvet product containing an active constituent—or vary an already registered product
• approve relevant particulars of a product label, or vary particulars already approved
• renew a product’s registration or the approval on an active constituent
• attain a minor use permit for an agvet chemical product?
• be given consent to import an agvet product or chemical
• attain an export certificate from the APVMA for an agvet product or chemical
• receive pre-application assistance from the APVMA
• have a technical assessment conducted by the APVMA before submitting an application
• review a decision made by the APVMA.

Applicants can also submit a hard copy application for a manufacturing license to produce veterinary medicines in Australia.

2. Assessment

The APVMA first conducts a preliminary assessment, within a month of an application being submitted. This is to identify if the application meets the application requirements—that is, the applicant has supplied the APVMA with the correct information and supporting documentation. If not, further information may be requested.

Next, the APVMA scientifically assesses each application within the legislated timeframe to make a decision to approve, register or refuse it.

The APVMA uses a scientific, evidence-based approach and aligns its regulatory efforts with the risks associated with each chemical. Risks are considered in terms of both the likelihood of exposure and the potential effects of exposure.

APVMA scientists analyse the information supplied by the applicant to in their application. This can include scientific data, reports, studies and other types of supporting documentation.

Part of the assessment is also reviewing certain information—known as the relevant particulars—intended to be printed on a product label.

The APVMA decision is based on whether the application—and the supporting documentation and information supplied—satisfies the statutory criteria as stipulated in the legislation and legislative instruments. This can include analyzing efficacy (effectiveness) data, as well data relating to protecting the safety of people, animals, plants and the environment.

3. Approval and register

The APVMA publically publishes certain information about products and active constituents on the agvet chemicals database, the permits database and on the website. Some of this information is published during the assessment process and some on approval or registration.

Some of the information published on each database record is the relevant particulars of a product’s label such as the product name and key ingredients—as well as the safety and use directions. The record will also identify if it has been listed as a reference product in another application and if so, for which products.

The APVMA maintains both the chemicals database and the permits database and updates records as required to reflect variations or any changes to a product, permit, license, label or active constituent.

4. Management of use

The States and Territories?are responsible for regulating the use of agvet chemicals. In some states, more than one government authority is involved. The APVMA regulates chemicals and products up to—and including—the point of retail sale.

Safe Work Australia and law enforcement can also be involved in managing the correct use of products to protect people, animals, crops and the environment.

5. Compliance

The individual, company or organisation responsible for a registered product—or approved active constituent—has an ongoing responsibility to comply with the Agvet Code. This can include ensuring labelling, advertising, manufacturing, importing, sales and supply of their product or active constituent—are all in line with requirements set out in agvet legislation.

The APVMA has certain powers to manage and monitor compliance—and undertake enforcement activities when required.

This can include monitoring compliance in the sale, supply, import, export, manufacture, labelling, packaging, storage and advertising of agvet products and active constituents. The APVMA is also responsible for conducting chemical reviews, managing reports of non-compliance?with the Code and investigating reports of adverse experiences from exposure to agvet chemical products.

The APVMA is also involved in enforcing compliance with the Agvet Code. Enforcement is carried out in partnership with law enforcement, the judiciary and other state, territory and Australian government agencies.