This content is current only at the time of printing. This document was printed on 25 February 2017. A current copy is located at http://apvma.gov.au/node/603
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When an active constituent is approved, an agvet product is registered, or a label for an agvet product is approved, the APVMA records certain particulars (the relevant particulars) on:
- the Record of Approved Active Constituents for Chemical Products (the Record)
- the Register of Agricultural and Veterinary Chemical Products (the Register) , and/or
- the APVMA file.
It is a requirement that relevant particulars are correctly maintained.
The holder or nominated agent can make an application to vary the relevant particulars or conditions of approval or registration (either standard or non-standard) at any time. The holder can also make an application to change the holder of the approval or registration or vary the nominated agent.
The Agvet Code allows us to vary the relevant particulars or conditions entered into the record or register if they are recorded incorrectly or if they are incorrect in a material respect and relate to:
- the signal words required by the current Poisons Schedules in relation to the approved label
- the street or postal address for the holder or the nominated agent.
The holder or nominated agent is obliged to notify us in writing within 28 days of becoming aware of any relevant particulars or conditions that relate to an approval or registration and are incorrect in a material respect or have been inaccurately recorded. Failure to do so is an offence. Once notified, we will correct the entry in the record, register or relevant APVMA file.
You should also notify us in writing if there are any changes in your (or your nominated agent’s) other details that are not relevant particulars or identifying information; for example, a change of contact person, telephone number or email address.
Maintaining Good Manufacturing Practice evidence
The holder of a veterinary chemical product registration is required:
- to comply with the condition of product registration to ensure Good Manufacturing Practice (GMP) compliance throughout the life of a product
- to maintain current and valid GMP evidence and submit this evidence when requested by the APVMA.
Change of manufacturer name with no change in site address
In the case of an Australian manufacturer where the manufacturer’s name is changed but the site, ownership and licence number remains unchanged, written notification with evidence that the licence has been updated is all that is required. A separate application is not required in this case. Where the ownership if the site changes (and a new licence issued), an application is required.
A name change for an overseas manufacturer requires written notification with GMP evidence confirming the name change or a statutory declaration from the manufacturer or holder of the registration regarding the change of name and date of the change.