This content is current only at the time of printing. This document was printed on 25 June 2021. A current copy is located at http://www.plural-consulting.com/node/10976
You are here
Holders will receive a notice with specific instructions about the regulatory process if their active constituent approval, product registration, or product label approval is under review.
Part 2, Division 4 reconsiderations
The Australian Pesticides and Veterinary Medicines Authority (APVMA) has powers under Part 2, Division 4 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) to conduct reviews of registered chemicals. In broad terms, these powers include the authority to reconsider the approvals of active constituents and product labels and the registration of products, and to require registrants to provide information. The APVMA can require holders to provide relevant information for the reconsideration, when holders are in possession of that information.
Information submitted to the APVMA may be eligible for compensation under Part 3 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code), if certain criteria are met.
Information obtained because of a trial or laboratory experiment and relating to an approved active constituent or registered chemical product which was given to the APVMA in response to a notice issued pursuant to section 32(1)(b) or section 33 (1) (a) or (c) of the Agvet Code, may be 'protected information' for the purposes of the Agvet Code.
If a holder considers that they are eligible for compensation under Part 3 of the Agvet Code, the APVMA should be provided with the details of the letters patent granted under the Patents Act 1952 or the Patents Act 1990, including the term of the letters patent (and any extension of that term) for the product or active constituent or an invention included therein (the 'protected active constituent'?or 'protected chemical product' as defined in section 3 of the Agvet Code).
Other types of label changes
New scientific information may suggest a change in the risks to human health, the environment, animal or crop safety, or trade for registered products. This information may be in the form of published scientific reports, regulatory changes in international jurisdictions, reports of adverse experiences in Australia or other types of information.
The formal reconsideration process for approvals and registration is outlined in Part 2, Division 4 of the Agvet Code. This process incorporates legislative, administrative and scientific elements that contribute to the final decision to affirm, vary, suspend or cancel an approval or registration. As a result, formal? reconsiderations can be complex, have high resource requirements and long timeframes. For these reasons, the APVMA seeks to address regulatory issues pragmatically by exploring alternative regulatory pathways before deciding to conduct a review.
After undertaking an analysis and/or a risk assessment of the information received, the APVMA may choose to take action outside a formal reconsideration to address any risks identified.
Holders can choose to voluntarily cancel their active constituent approval, product registration, or label approval at any time by making a written application to the APVMA in accordance with s 42 of the Agvet Code. These voluntary cancellations are published in the Gazette.
To make a request for a voluntary cancellation at the request of the holder, download the form.
Variation with the consent of the holder
The relevant particulars or conditions of an active constituent, chemical product, or the label for a chemical product can be varied. This can happen at the request of the holder, or the APVMA may vary on its own initiative with the holder’s consent (in accordance with s 29A of the Agvet Code).
Alternatives to formal reconsideration
The APVMA has powers under Part 2, Division 5 of the Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code) to take action outside the scope of a formal reconsideration. In broad terms, these powers include the authority to suspend or cancel product registrations, active constituent approvals and label approvals in response to holders contravening certain aspects of the Code. The APVMA may also take action when it appears to the APVMA that products, labels or active constituents may no longer meet the statutory criteria, related to safety, efficacy, labelling or trade, set out in section 5 of the Code.
Immediate suspension or cancellation
Under s 35A of the Agvet Code, the APVMA may suspend or cancel the registration of a chemical product if the APVMA considers doing so is necessary to prevent imminent risk to people of death, serious injury, or serious illness.
Under s 41 of the Agvet Code, the APVMA may suspend or cancel the approval of an active constituent for a proposed or existing chemical product, or the product registration, if it appears to the APVMA:
- for an active constituent – that the constituent may not meet the safety criteria; or
- for a chemical product – that the product may not meet the safety criteria, the trade criteria or the efficacy criteria; or
- that the constituent or product may not comply with any requirement prescribed by the regulations.
The APVMA may suspend or cancel the approval of a label for containers for a chemical product if it appears to the APVMA that the label may not meet the labelling criteria or may not comply with any requirement prescribed by the regulations.
Before suspending or cancelling active constituent approval, product registration or label approvals in this situation, the APVMA must notify holders and nominated agents (under s 34P of the Agvet Code) and the states and territories (under s 35 of the Agvet Code) of the proposed regulatory decisions. The APVMA must also invite and consider submissions from holders and nominated agents (under s 34P of the Agvet Code) and the states and territories (under s 35 of the Agvet Code) prior to making a final regulatory decision.
Suspension or cancellation of products and labels under these circumstances may lead to a deemed permit being issued (under s 45B of the Agvet Code) for up to 12 months. The deemed permit may contain instructions for use, possession, custody and supply. However, if the risk is significant, the APVMA may declare that the deeming provision ceases to apply, or that the permit is issued for a duration of less than 12 months.
More information on label reviews can be found on our website.
Interrelated suspensions and cancellations
Section 44 of the Agvet Code provides that in certain circumstances the APVMA is either obligated to (must), or has the option to (may), take interrelated action when it suspends or cancels approvals or registrations.
If the APVMA suspends or cancels the approval of an active constituent, it must also suspend or cancel any product registration for that active constituent.
If the APVMA suspends or cancels the registration of a chemical product, it may also suspend or cancel any approval relating to a label for containers for the product.
If the APVMA suspends or cancels the only approved label, or all the approved labels, for containers of a chemical product, it may also suspend or cancel the product registration.