This content is current only at the time of printing. This document was printed on 20 February 2018. A current copy is located at https://apvma.gov.au/node/67
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The ongoing responsibilities of holders
A ‘holder’ is the person or company responsible for an approved active constituent, registered agvet chemical product, approved permit or approved manufacturing licence within the Australian marketplace.
The holder of an approval or registration is the person or body corporate listed in the APVMA’s Record or Register (either as the original party making the application, or the party who has accepted ownership through subsequent approval or registration transferral). The holder of a permit or licence is the party to whom the permit or licence has been issued.
Holders are responsible for all aspects of their approval or registration in the Australian marketplace including, where applicable, quality, efficacy, stability and broadly advertised claims.
When issues relating to an approval or registration are brought to the APVMA’s attention, our initial point of contact is the holder or, where relevant, their nominated agent. The extent of the holder’s involvement in the matter can then be determined. For example, it is possible that claims may be made about a product that are independent of, and not supported by, the holder. In these instances, we will focus any compliance action on the author of the claim.
Should materials or products be identified as counterfeit, we acknowledge that they are unlikely to be the responsibility of the holder of the ‘real’ product. We will most likely treat counterfeit products as unregistered agvet chemical products and compliance action will focus on the persons responsible for importation, manufacture or supply of these products.
As a holder of an APVMA approval, registration, permit or manufacturing licence, you are responsible for:
- being aware of (or having the ability to become aware of) your obligations under agvet legislation that governs manufacture, import and supply of agvet chemicals
- complying with the Agvet Code and other relevant Commonwealth, state and territory legislation
- maintaining accurate records relating to your agvet chemicals
- abiding by licence scope and conditions
- maintaining appropriate manufacturing and formulation standards for agvet chemicals
- handling chemicals responsibly and in accordance with Commonwealth, state and territory requirements.
We expect holders to be responsible corporate citizens by:
- notifying us when necessary, and as part of fulfilling your obligations under the Agvet Code, in an honest and transparent way
- letting us know of any difficulties complying with requirements or conditions, as soon as possible
- using the appropriate mechanism to advise us within the required timeframe of any variations to the details of an agvet chemical product, its label or intended use
- providing reasonable assistance to our voluntary requests for information, data or records
- providing timely cooperation with all lawful requirements and directions from APVMA Inspectors
- alerting us to any adverse experiences
- alerting us to potential non-compliance, including providing any information to the APVMA suspected to be false and/or misleading, and alerting us about any suspected fraudulent activity.
If you are a nominated agent for an approval or registration, you have the same responsibilities as a holder.