Use of international data, assessments, standards and decisions—guide for applicants

Background

The Australian Government has set the guiding principle that if a system, service or product has been approved under a trusted international standard or risk assessment then Australian regulators should not impose any additional requirements unless it can be demonstrated that there is a good reason to do so.

Criteria have been developed which clearly describe how international data, standards and assessments can be better used as part of the risk assessment processes we undertake as part of the approval of an active constituent, registration of a product or approval of a label.

The provision of an assessment from an overseas regulator with accompanying data is one of a group of proposals aimed at reducing the regulatory burden for industry and is part of the reform agenda being considered by the APVMA and the Department of Agriculture and Water Resources.

Impact for applicants

In some cases, the use of overseas information available from another regulator may lead to a faster decision. Although it is important to note that this policy doesn’t change the legislative safety tests or the regulations associated with approvals and registrations of active constituents and products—which must still be met before a product can be registered in Australia.

Any decision to grant an approval for an active constituent or to register a product will continue to be made in line with the requirements of the Australian Agvet Code.

Questions about the use of information from regulators which are not covered in the policy document or the user guides can be directed to the APVMA’s Scientific Assessment and Chemical Review team.

Applicants wishing to use an international assessment to support all or part of an application should discuss this with the APVMA prior to making an application.

Consultation and implementation

We have undertaken extensive consultation on this work to ensure the final policy and its operation are workable for both the APVMA and industry, including:

  • seeking industry comment on the proposed policy approach to the use of international data, assessments, standards and decisions—during 2015
  • seeking industry comment on two user guides—mid 2016.

Following the first round of consultation on the policy in 2015, industry told us they wanted more detail on how the policy would work in practice for both agricultural and veterinary products and a second round of consultation sought feedback on two user guides.

The final policy will be implemented towards the end of 2016 and include a more detailed operational framework and guidance for industry.

See details of the consultation documents.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.