Regulation

Animal Medicines Australia (AMA) supports The Council of Australian Governments (COAG) Principles of Best Practice Regulation; the Ten Principles for Australian Government Policy Makers; and the development of a best practice regulatory culture towards delivering high quality advice, regulatory oversight, programs and services.

These principles, embodied in AMA’s Position Statement on Best Practice Regulation, are critical to ensure that regulatory responses are properly targeted and proportionate. They are supported by AMA as an essential framework which can be used to assess the merits of any legislative or regulatory proposal.

In Australia, veterinary medicines are regulated through the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS). The NRS comprises:

  • The Australian Pesticides and Veterinary Medicines Authority (APVMA) – a partnership between the Commonwealth and the states and territories under which the APVMA is established as a Commonwealth statutory authority, with responsibility for the evaluation, registration and review of agricultural and veterinary chemicals and their control up to the point of retail sale; and
  • The States and Territories having responsibility for control-of-use activities and administer specific legislation and requirements.

Under APVMA requirements veterinary medicines must meet specific criteria for safety, efficacy, trade, and labelling; as well as other requirements and standards.

The APVMA manages potential risks posed by veterinary medicines by, among other things, imposing conditions on approvals or registrations, and through requiring that certain information be contained on chemical product labels.

As part of the assessment processes, the APVMA receives input from other Commonwealth agencies, including:

The APVMA Adverse Experience Reporting Program (AERP) is a post-registration program that assesses reports of adverse experiences associated with the registered use of a veterinary medicines. The program provides a useful feedback loop to registrants and the regulator.

In some circumstances international Treaties and Conventions, including their local management may be relevant.

Registrants of veterinary medicines are also required to comply, when relevant, with other Australian regulators including the Australian Dangerous Goods Code (National Transport Commission), Workplace labelling (Safe Work Australia), biological imports, and the Office of the Gene Technology Regulator.

 

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