Guideline for storage stability data

Submissions are invited from interested stakeholders on the proposed amendments to the guideline Generation of storage stability data for agricultural chemical products.

Background

The purpose of guidelines is to increase the transparency and predictability of APVMA decision making under the Agvet Code. APVMA data guidelines provide guidance on what information should be provided with an application, increase understanding and predictability of our decisions and demonstrate how we ensure that the agvet chemicals for supply in Australia can be used safely and are effective.

The APVMA is seeking stakeholder input on the updates to the generation of storage stability data for agricultural chemical products. The following describes the proposed changes:

• added pack size guidance (section 1.1) describes when storage stability data might not be required for larger or smaller (no more than 50% smaller) pack sizes with some examples provided
• a new section (section 1.2) describing when stability data could be extrapolated across to an alternative packaging material (such as from HDPE to fluorinated HDPE)
• guidance has been added to section 2.4 ‘Real-time testing’ to include normal intervals for testing and some examples
• accelerated storage stability testing information has been moved across from Node 1045 ‘Registration of an agricultural product’ to section 2.3 of Node 1042 ‘Generation of storage stability data for agchem products’
• an additional table has been added to Section 3.2. ‘Parameters to be tested in stability trials’—table 14: Water Soluble Granules (SG).

The consultation period is open until close of business on 22 March 2019. Following consideration of comments received during the consultation period the data guideline will be finalised and made available on the APVMA website.

Please send your written submission by email to enquiries@apvma.gov.au