This content is current only at the time of printing. This document was printed on 11 September 2020. A current copy is located at http://www.xlg888.com/node/26661
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The APVMA must record the name and address of each manufacturer of a chemical product in the Register of Agricultural and Veterinary Chemical Products (the Register). Applicants can either provide the manufacturing details in the application or opt to have the manufacturing details provided separately by the manufacturer instead.
Applications need to include information about every manufacturing site involved in the product’s manufacture.
All new product registration applications need to include information about the manufacturing site involved in the product’s manufacture. If you seek to vary or add a new manufacturer, an application must be lodged with the APVMA. Further information on varying the sites of manufacture is available.
The applicant should:
- ensure manufacturer names and ACNs/ABNs entered are consistent with details registered with the Australian Securities Investments Commission (ASIC) or overseas equivalent
- provide details for all toll, contract and subcontractor parties involved in formulating, filling, packaging, labelling, analysis and/or testing, up to and including the product’s release for supply
- provide information about the steps of manufacture that occur at each site. From the list provided, you can select all steps of manufacture, if appropriate or only those which are relevant.?
Veterinary chemical products only
- manufacturers of veterinary chemical products in Australia must be licensed by the APVMA unless specifically exempt. You will be required to provide the APVMA licence number and select the category of licence held by each manufacturer
- more information about manufacturing licences for veterinary products is available.
Manufacturers of active constituents
Applications for product registration must include information about each active constituent’s manufacturer. If the active constituent is already approved, its approval number needs to be included as well.?Approved active constituents are listed on?the PUBCRIS database.
The applicant should:
- ensure the manufacturer’s official name and ACN/ABN is written exactly as listed with ASIC
- provide the address for the manufacturing site of the active constituent.
Applications for a repacked product must include a manufacturer’s declaration by—or on behalf of—each manufacturer of the new product. The declaration needs to confirm that the sites of manufacture and the equipment used, the ingredients and formulation, the manufacturing process and specifications of the product—and the containers—will be the same between the new repacked product and the original registered reference product and that there will be no additional pack sizes.
Manufacturer’s declarations can be provided by the applicant or the manufacturer and should cover all steps of manufacture. If the manufacturer is submitting the declaration directly to the APVMA, this needs to be provided within 7 days of the application submission.
A manufacturer’s declaration template is available for your use.