The Australian Pesticides and Veterinary Medicines Authority
In brief: Senior Associate Caroline Ryan gives an overview of the regulatory framework for the assessment and registration of pesticides and veterinary medicines in Australia.
- Background
- National Registration Scheme legislation
- Types of registration
- Steps in having a chemical product registered
- Conclusion
Background
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is the Australian Government agency responsible for the assessment, registration and regulation of pesticides and veterinary medicines, up to and including the point of retail sale. The APVMA exists within the portfolio of the Minister for Agriculture, Fisheries and Forestry, the Hon. Warren Truss MP.
The APVMA administers the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS) in partnership with the States and Territories and with the active involvement of other Australian government agencies, such as the Therapeutic Goods Administration and the Gene Technology Regulator.
National Registration Scheme legislation
The NRS is governed by a statutory framework that incorporates the following seven Acts:
- the Agricultural and Veterinary Chemicals Act 1994;
- the Agricultural and Veterinary Chemicals Code Act 1994;
- the Agricultural and Veterinary Chemicals (Consequential Amendments) Act 1994;
- the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994;
- the Agricultural and Veterinary Chemical Products Levy Imposition (Customs) Act 1994;
- the Agricultural and Veterinary Chemical Products Levy Imposition (Excise) Act 1994; and
- the Agricultural and Veterinary Chemical Products Levy Imposition (General) Act 1994.
The centrepiece of this suite of legislation is the Agricultural and Veterinary Chemicals Code (the Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994, that contains the detailed operational provisions for:
- registering chemical products and providing the APVMA with its full range of powers, including the evaluation, registration and review of agricultural and veterinary chemical products (including active constituents and product labels);
- the issuing of permits;
- the control of the manufacture of chemical products;
- controls regulating the supply of chemical products; and
- provisions ensuring compliance with, and for the enforcement of, the Code.
Types of registration
There are three tiers of registration for agricultural and veterinary chemical products according to the level of risk posed by the products and the appropriate management framework.
Registered chemical products
Registered chemical products encompass the highest risk products and have rigorous assessment processes. By definition, these include products that:
- prevent, diagnose, cure or alleviate animal disease; or
- modify the physiology of the animal.
Listed registration chemical products
Listed registration chemical products are lower risk products which do not warrant the rigorous assessment process that applies to registered chemical products, particularly given the known risks associated with their use.
Products can be listed against a standard that has received the approval of the Minister for Agriculture, Fisheries and Forestry, on the basis that the APVMA is satisfied that the use of the product or class of products in accordance with the standard would be safe, effective and not a trade risk.
Reserved chemical products
Reserved chemical products is a simple system of regulating low risk products by excluding reserved products from regulatory control. Provided the product complies with any conditions set by Regulations, the products are excluded from the offence provisions of the National Registration Legislation.
Steps in having a chemical product registered
Registration of a new product with the APVMA may take up to 18 months or more to complete.
The basic steps involved in having a chemical product registered are as follows:
Application
An Application must be in writing and be accompanied by any information that the APVMA requires for that particular product category.
If the Application covers an active constituent or a new chemical product, it must include the proposed instructions for the use of, or other dealing with, the constituent or product.
Screening - preliminary assessment
The APVMA must, within one month of receiving an Application, make a preliminary assessment as to whether the Application complies with the required formalities. This involves both administrative screening, and some technical screening.
If the formalities are complete, notice is given that the Application has passed a preliminary assessment and will be given full evaluation.
Once an Application passes screening, it is assigned to an evaluator for full evaluation.
Publication
As soon as practicable after an Application is acknowledged, the APVMA must publish a summary of the Application in the APVMA Gazette, and make it available for public comment where relevant.
A period of public consultation follows, during which time members of the public and relevant industry bodies have an opportunity to raise matters of concern about human, animal and environmental safety, efficacy and trade. These comments are then considered before a final decision is made to register the product.
Evaluation process
Evaluation begins when a complete Application, with all the required data and the relevant fee, are submitted. Legislated timeframes for evaluation can range from three to 15 months.
During the evaluation process, the APVMA takes full account of the nature of the product, the amount and completeness of the data for review, and the extent of consultation required between the APVMA, manufacturers, advisory agencies, and State and Territory departments. This process includes reviewing the Application in relation to the following categories:
- Chemistry & Manufacture;
- Toxicology;
- Metabolism and Toxicokenitics;
- Residues;
- Overseas Trade Aspects;
- Occupational Health & Safety;
- Environmental Aspects;
- Efficacy and Safety; and
- Any Special Data Requirements.
Approval
When the APVMA approves a chemical product for registration, the Applicant is issued with a Notice of Registration and/or label approval. This Notice contains an APVMA Approval Number which the registrant must display on all labelling for the product.
Under the Code, registrants are under an ongoing obligation to inform the APVMA of any:
- adverse experiences in relation to a registered product;
- information about a product that contradicts any information previously submitted to the APVMA or that indicates that the product may have an unintended harmful effect;
- significant change in the chemical characteristics of a product (such as an unforeseen breakdown in stability) or the performance of the product and of any corrective action that they propose to take.
Conclusion
In most cases, before agricultural and veterinary chemical products can be sold, supplied, distributed or used in Australia, they must be registered by the APVMA.
A future edition of Biotech News will feature an overview of the APVMA's recently revised Guidelines for the Registration of Biological Agricultural Products. In the interim, further information on the requirements of the APVMA can be obtained at http://www.apvma.gov.au/.
For further information, please contact:
- Dr Trevor DaviesPartner, Allens Arthur Robinson Patent & Trade Marks Attorneys,
Sydney
Ph: +61 2 9230 4007
Trevor.Davies@aar.com.au
