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/81
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Holders, nominated agents and authorised agents
View the quick reference guide to the roles and actions of holders, nominated and authorised agents and authorising parties.
A holder is the person entered in the APVMA’s records as the person or organisation responsible for an active constituent approval, agvet chemical product registration, label approval, permit approval or manufacturing licence.
A holder may be any individual or registered body corporate (such as a limited liability company).
A nominated agent acts on behalf of a holder and, under Agvet Code, is taken to have the same responsibilities (see Division 4 of Part 1 of the Agvet Code-sections 8L to 8R).
The role of a nominated agent comes into effect once a product is registered or an active has been approved and endures for the life of the product, unless withdrawn by the holder or by the nominated agent. Access is granted to specified product number/s or active approval/s.
The nominated agent must be a resident of, or carry on a business in, Australia.
Overseas holders and nominated agents
The Agvet Code requires there to be a person in Australia with the same responsibilities as the holder (see section 8R). It is therefore a condition of registration for an overseas holder to appoint a nominated agent for each approval or registration. This is particularly important in relation to:
- notices and records, where the APVMA may be unable to deliver notices to, or obtain records from, an overseas holder, and
- offences, where the APVMA may be unable to take legal action against the overseas holder.
The APVMA may suspend or cancel an approval or registration of an overseas holder if there is a contravention of this condition of approval.
Domestic holders may voluntarily opt to use a nominated agent.
Disclosure of confidential commercial information to a nominated agent
The APVMA may be restricted in the extent to which it can disclose confidential commercial information about an active constituent or chemical product to a nominated agent. Generally speaking, the APVMA can only disclose such information to a nominated agent if the 'authorising party' for the information—who will often be the holder of the approval or registration—agrees in writing.
If you are a nominated agent and the authorising party has given you ongoing permission to access confidential commercial information, you should inform the APVMA, including providing a letter of authorisation from the authorising party If you need to access information held by the APVMA from time to time, you can make such a request in writing and the APVMA will consider whether the information can be disclosed to you.
Holder and nominated agent details
The holder of an approval (except for a manufacturing licence) or registration can apply to change the holder, appoint a nominated agent or vary a nominated agent. An application for a new licence is required to transfer a manufacturing licence to a new manufacturer.
A separate application and fee are not required to appoint or vary a nominated agent if the change is made in conjunction with the lodgement of an application to approve, register or vary an active constituent, agvet chemical product or permit.
There is no requirement for the existing nominated agent to consent to the transfer of the nominated agent status, nor any requirement to notify them of the change.
A nominated agent may at any time submit a signed written request to withdraw from their status as nominated agent. However, the APVMA must be satisfied that the nominated agent has notified the holder about their withdrawal before the variation can be accepted.
Applying to appoint or vary the holder or nominated agent
An application to appoint or vary the holder or nominated agent must be made online. The application must include consent from the new holder or nominated agent, the prescribed fee and any information set out in the legislative instrument for information to be provided with application. If the application includes all the relevant information, the APVMA must accept it within one month.
An authorised agent is an agent under common law. An authorised agent must accept their appointment in writing.
Applicants may appoint an authorised agent—such as a registration consultant—to act on their behalf during the application process. In addition, an applicant who resides in Australia or conducts business in Australia may appoint an authorised agent to act on their behalf on an ongoing basis. Overseas entities can only use authorised agents to assist with the application process for approval or registration (and are required to have a nominated agent once approval and/or registration is completed).
An authorised agent may act on behalf of the current or prospective holders in the context of applications. A nominated agent for an overseas holder may also engage an authorised agent to assist with variations to registrations and approvals.
An authorised agent may also report and calculate levies for the purposes of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 and/or provide information relating to the annual return of actives under the Agricultural and Veterinary Chemical Products (Administration) Act 1992.
These authorised agents have responsibilities in relation to their interactions with the APVMA—for example, they must not provide false or misleading information. However, an authorised agent does not have the same obligations that a nominated agent has.
An authorised agent may be appointed for a specific period or a specific task for holders who reside in Australia or are registered to conduct business in Australia. The appointment ceases on completion of the timeframe or task (or if the appointment is terminated). In other cases (ie for overseas applicants), the appointment ceases when the application is finalised or if it is withdrawn prior to finalisation.