Seeking stakeholder input into the use of international data, assessments, standards and decisions

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is inviting written submissions from interested stakeholders on the formation of its policy on the use of international data, assessments, standards and decisions.

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, Australian regulators should not impose any additional requirements unless it can be demonstrated that there is a good reason to do so.

Draft policy

We have developed criteria to clearly indicate how international data, standards and assessments can be better utilised as part of the risk assessment processes that we are required to undertake as part of the approval of an active constituent, registration of a product or approval of a label. These criteria are listed in our draft policy document APVMA’s approach to use of international data, assessments, standards and decisions. 

The draft policy also outlines:

• existing standards already in use
• circumstances in which international standards may not be used
• our position on the use of overseas regulatory decisions
• requirements for the protection of intellectual property.

Guidance to applicants on the use of international data is outlined in Use of international data, assessments, standards and decisions—a guide for applicants.

Consultation information

The APVMA is seeking feedback in relation to the draft policy to ensure it provides clear information and guidance to assist applicants.

The consultation period is open until close of business on Friday 10 July 2015. Following consideration of comments received during the consultation period the policy will be finalised and made available on the APVMA website.

Please lodge your written submission by email, post or fax to:

Scientific Assessment and Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604

Email: consultations@apvma.gov.au   

Fax: +61 2 6210 4776