This content is current only at the time of printing. This document was printed on 12 December 2021. A current copy is located at http://www.ipagescanada.com/node/67
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Responsibilities of holders
Once a product is registered or a chemical active is approved, the holder has certain ongoing compliance responsibilities under the Agvet Code.
Holders are responsible for all aspects of an Australian Pesticides and Veterinary Medicines Authority (APVMA) approval, registration or permit, including quality, efficacy, stability and advertised claims. Other aspects involve:
- being aware of their obligations under agvet legislation governing 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 agvet chemicals
- if applicable, abiding by their manufacturing 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.
Nominated agents for an approval or registration have the same compliance responsibilities as holders??
A holder may also appoint a nominated agent to act on their behalf – meaning the nominated agents for an approval or registration have the same compliance responsibilities as holders. Nominated agents must familiarise themselves with their responsibilities under the Agvet Code.
Communicating with APVMA Assessment, Investigation and Monitoring
The APVMA expects holders to communicate appropriate information to the APVMA when necessary. This includes:
- letting the APVMA know of any difficulties complying with Agvet Code requirements or conditions as soon as possible
- using the appropriate mechanism to advise the APVMA?of any variations to the details of an agvet chemical product, its label or intended use
- providing reasonable assistance to the APVMA’s voluntary requests for information, data or records
- reporting potential – or actual – non-compliance
- alerting the APVMA of any suspected fraudulent activity.
Change to details or information
At any time, a holder of an active constituent approval or product registration can apply to transfer the approval or registration to another person or entity.
As the holder of an approval or registration, you must notify the APVMA if you – or your nominated agent’s –?details change. This includes identifying information such as street or postal address, contact person, telephone number or email address.
Your nominated agent may notify us of these changes on your behalf.
If you are the holder of a manufacturing licence, you cannot transfer your licence to the new manufacturer. In this situation, the new manufacturer must make an application for a new licence. If they already hold a manufacturing licence, they must ensure that it covers all relevant manufacturing steps for the veterinary chemical product in question.