This content is current only at the time of printing. This document was printed on 29 April 2017. A current copy is located at http://apvma.gov.au/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 opt to have the manufacturing details provided separately by the manufacturer instead of completing this section.
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. For product variation applications, this information is required if there is a new manufacturer and/or manufacturers to be removed.
- Ensure manufacturer names and ACNs/ABNs entered are consistent with details registered with the Australian Securities Investments Commission (ASIC) or overseas equivalent.
- Details are required 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.
- Information is required 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 licenced 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 licenses for veterinary products is available from our website.
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 constituent names and numbers are listed on our registered chemicals database.
- The manufacturer’s official name and ACN/ABN needs to be written exactly as listed with ASIC.
- The address required is 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 product. The declaration needs to confirm that the sites of manufacture, the formulation, the manufacturing process and specifications of the product—and the containers—will be the same between the repacked product and the original registered reference product.
All manufacturer’s declarations need to be obtained prior to submission and uploaded to the information list in the online application or by using the information list editor. If the manufacturer is submitting the declaration directly to the APVMA, this needs to be provided with 7 days of the application submission.
More information about what to include in your manufacturer’s declaration is available from the required information page on our website.