Seeking comment on draft legislative instruments

The APVMA has released a number of draft legislative instruments for public consultation.

Background

The APVMA CEO can make legislative instruments under the Agvet Code on a range of matters regarding regulation of agricultural and veterinary chemical products. Legislative instruments operate as law, as opposed to being guidance material, and must be complied with.

There are a number of legislative instruments under the Agvet Code that were made prior to the Agvet Reforms. As part of the legislative reform package, these legislative instruments are being remade or, in a number of cases where they are no longer relevant, repealed.  In addition, there are a number of new legislative instruments that have been created as a consequence of the Agvet Reforms.

In order to ensure that the legislative instruments are effective and provide clear information, the following draft legislative instruments that will be in force after 1 July 2014 have been released for public consultation.

Draft Instruments

Pre-application Assistance - This instrument sets out what constitutes a unit of pre-application assistance for each of the different kinds of assistance provided by the APVMA. Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 (PDF, 155kb)

Information to be Included in Applications (Application Requirements) - This instrument sets out the information that must be contained in, or accompany an, application under the Agvet Code. Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 (PDF, 494kb)

Efficacy Criteria - This instrument sets out the criteria that are applied when considering whether a chemical product meets the efficacy criteria (as required by s14(1)(c) of the Agvet Code). The instrument sets out a class of chemical products that meet the efficacy criteria without further investigation of efficacy being required. Agricultural and Veterinary Chemicals Code (Efficacy Criteria) Instrument 2014 (PDF, 144kb)

Joint Health Products for Dogs and Horses - Section 8U of the Agvet Code provides that standards may be made for listed chemical products. The Standards may set out labelling and handling requirements. This instrument relates to veterinary chemical products, the long term use of which may help improve joint health and function in dogs and horses. Agricultural and Veterinary Chemicals Code (Listed Chemical Product - Joint Health Products for Dogs and Horses Standard 2014 (PDF, 264kb)

Home Swimming Pool and Spa Products - Section 8U of the Agvet Code provides that standards may be made for listed chemical products. The Standards may set out labelling and handling requirements. This instrument relates to agricultural chemical products used for destroying bacteria, viruses and protozoa in home swimming pools and spas. Agricultural and Veterinary Chemicals Code (Listed Chemical Product - Home Swimming Pool and Spa Products) Standard 2014 (PDF, 549kb)

Manufacturing Principles - This instrument sets out the written principles to be observed in the manufacture of veterinary chemical products, unless the products are exempt from licensing under the Agvet Regulations. Agricultural and Veterinary Chemicals (Manufacturing Principles) Determination 2014 (PDF, 133kb)

Consultation Information

APVMA is seeking feedback from industry in relation to the draft legislative instruments to ensure they provide clear information and guidance to assist applicants through the registration process.

The consultation period is open to 21 May 2014. Following consideration of comments received during the consultation period, the legislative instruments will finalised by mid-June and made available from the APVMA website.

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

General Counsel
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON  ACT  2604

Email: regulatoryguidelines@apvma.gov.au

Fax: +61 2 6210 4840