48Unregistered chemical products

48 Unregistered chemical products

(1) If the chemical product is not a registered chemical product, the application must contain, or be accompanied by, the following information: (a) whether the product has been registered (or similar) in countries other than Australia in relation to the proposed use and, if so, the name of the countries and, if available, copies of the relevant labels for the product; (b) in relation to each manufacturer of the product in Australia: (i) whether the manufacturer is aware of the application; and (ii) any data provided by the manufacturer that would support the application; (c) the formulation information for the product; (d) if the product is imported into Australia – details of the importation and evidence of any consent provided by the APVMA for the purposes of subsection 69B(1B) of the Agricultural and Veterinary Chemicals (Administration) Act 1992; (e) the name and address of each supplier of the chemical product; (f) the following information about each manufacturer of the product: (i) the name of the manufacturer (if the manufacturer is a company, the company’s name); (ii) if the manufacturer has an ACN – the ACN; (iii) if the manufacturer is an overseas company and has a number equivalent to an ACN – that number; (iv) the street address of each site at which steps in the manufacturing process are undertaken by the manufacturer; (v) the steps in the manufacturing process which take place at that site; (g) for a veterinary chemical product – the name, street address and licence number of the person who performs release for supply of the product; (h) for a veterinary chemical product – the licence number of each person who performs a step in the manufacture of the product in Australia; (j) for a veterinary chemical product – in relation to each person who performs a step in the manufacture of the product outside Australia: (i) an original or notarised certificate of good manufacturing practice, issued by an authority recognised by the APVMA, that the performance of that step complies with the manufacturing principles or a comparable good manufacturing practice code; and (ii) an original or notarised copy of an audit report on good manufacturing practice from an auditor from an authority recognised by the APVMA, and evidence that any identified non-conformances have been addressed and that the person’s facility complies with the manufacturing principles or a comparable good manufacturing practice code; and (iii) other evidence demonstrating the person’s good manufacturing practice; (k) for each active constituent of the product: (i) the name of the constituent; and (ii) if the active constituent has been approved – its distinguishing number; and (iii) the name of the manufacturer of the constituent and the street address of the site at which it is manufactured; (l) the following information about the containers of the product: (i) the proposed size of the containers; (ii) a description of the containers, including an explanation of the extent to which the containers are in direct contact with the product; (iii) the method by which the approved label will be attached to the containers; (iv) details of the labelling of the product; (m) the proposed shelf life expiry period for the product (if applicable); (n) the proposed storage conditions for the product; (o) safety criteria information for the product and information relevant to whether the product would meet the efficacy criteria; (p) if the chemical product is a veterinary chemical product and contains ingredients of a biological origin that have been, or are to be, imported into Australia—a copy of the relevant permits (or similar) for the importation of the product for the purposes of the Quarantine Act 1908 or a copy of any applications for such permits. (2) A document referred to in subparagraph (1)(j)(i) or (ii) may be provided electronically, but if it is, the applicant must retain a hard copy of the document for provision upon the APVMA’s request.