Seeking stakeholder input on two user guides for the use of international data, assessments, standards and decisions

The APVMA has now finalised its policy approach to the use of international data, assessments, standards and decisions following broad consultation with industry throughout 2015.

The policy 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.

Industry feedback was that people wanted more detail on how the policy would operate and greater guidance from the APVMA on what data, standards and assessments would be acceptable. The APVMA has now developed two user guides which provide greater detail on the specific requirements for agricultural and veterinary chemicals.

Written submissions are now invited on these two user guides:

• Use of international data, standards and assessments: a guide for agricultural chemical products
• Use of international data, standards and assessments: a guide for veterinary chemical products

These user guides set out information on the types of data, assessments and standards that are:

• either acceptable to the APVMA
• would be considered by the APVMA
• adopted by the APVMA.

They also outline guidance on:

• the different assessment disciplines
• the type of specific regulatory information needed
• what is appropriate for each type of assessment.

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.

Consultation information

The consultation period has been extended until close of business on Friday 17 June 2016. Following consideration of comments received during the consultation period, the user guides 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