This content is current only at the time of printing. This document was printed on 24 January 2017. A current copy is located at http://apvma.gov.au/node/92
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Applying for approvals, registrations and variations
Applications are made to the APVMA to approve, register or vary active constituents, products, or labels. An application must be supported by information that allows us to determine whether we are satisfied that the product meets the applicable statutory criteria (safety, trade, efficacy and labelling criteria).
Approval of active constituents and registration of agvet chemical products
For a new agvet chemical product that contains a new active constituent, the APVMA must approve the active constituent before we register the product. Once approved, the active constituent may then be used in new agvet chemical products that are presented for registration.
Each registered product must have a label containing the instructions approved by the APVMA including adequate instructions for the safe and effective use of the product and for its storage, handling and disposal. Products cannot legally be supplied without having a label containing these instructions attached to their containers.
All veterinary chemical products must be manufactured in premises that comply with the Code of Good Manufacturing Practice, unless the product is excluded or exempt from the scheme (such as listed or reserved products or products like skin cleansers, shampoos or sheep branding substances). Australian facilities must be licensed by the APVMA, or hold a permit, and overseas manufacturers must provide equivalent evidence of compliance at the time of application for registration of products.
The type and nature of the information we require to determine whether a product meets the statutory criteria varies according to the applicant’s proposal for registration and the information provided in the application. For example, an applicant might choose to provide scientific data or argument to address all or some of the criteria. Alternatively, if the product is chemically or closely similar to an already registered product (a ‘reference product’) and has the same use patterns as that product, you could nominate that reference product as evidence that all of the criteria have already been met, relying on our previous decision to register the reference product. The use of reference products in this way may depend on whether there are limits on the use of information associated with the reference product or confidential commercial information for which the APVMA requires consent from the owner of the information before it can be used in support of your application.
The legislative instrument for information to be provided with applications sets out the information requirements for applications. Guidelines on the how to address the types of information that may be submitted are in the data guidelines section. Applications that involve considerable data assessment will have higher fees and longer assessment timeframes than those that rely on fewer assessments or use of reference products.
The APVMA also accepts timeshift applications for the approval of a new active constituent and the registration of an associated chemical product. Under a timeshift application arrangement, we work with the applicant to agree on a project plan that sets out the timeframe for conducting the necessary assessments to allow us to consider our satisfaction against the safety, efficacy and trade criteria. The same fees apply as for a non-timeshift application, as the assessment components are the same.
Timeshift applications can be particularly useful to facilitate global joint reviews (GJRs). A GJR is the concurrent evaluation of a new active constituent and associated agricultural chemical product through a globally coordinated system of evaluations, peer reviews and report-sharing with other comparable regulators, typically OECD member governments.
Variations to active constituents, agvet chemical products and labels
Once an active constituent, label or agvet chemical product is approved, the relevant particulars or conditions may be varied. Variations to products include adding new crops, animal species, use situations or statements to the label, amending the site/s of manufacture, making minor variations to the formulation and adding new pack sizes. Although all of the statutory criteria are considered in the assessment of a variation application, applicants will usually only need to provide information that addresses the nature of the variation and whether the product, constituent or label continues to meet all of the statutory criteria.
An application for a variation of a relevant particular or condition can be made:
- by the holder
- by the nominated agent
- by any other person with the consent of the holder
Variations can also be made on the APVMA’s own initiative, with the consent of the holder.
Aspects of labels that are not relevant particulars or wording required as a condition of label approval may be varied without the specific approval of the APVMA. Any such variations must comply with the mandatory aspects of the Ag or Vet Labelling Code - where the word 'must' is used in the Codes.
You must notify us within 28 days if you believe we have inaccurately recorded a relevant particular or condition, and you must tell us the correct particular or condition. Not doing so is an offence.
We can also amend an incorrect relevant particular or condition if it relates to the signal words required by the current Poisons Standard for an approved label, or if the street or postal address of the holder or the nominated agent changes.
Applying for an approval, registration or variation
An application for approval, registration or variation must be made online through the APVMA portal. The application must include the prescribed fee and any information set out in the legislative instrument for information to be provided with applications.