27Information in the application — general

27 Information in the application – general

(1) The application must contain the following information: (a) the name of the registered chemical product to which the application relates and its distinguishing number; (b) if the application seeks to change the name of the product – the proposed name; (c) the distinguishing number for the existing approved label and the pack size; (d) a statement of the purpose of the application and a description of the use of the chemical product; (e) the applicant details; (f) the applicant declaration; (g) whether the applicant considers that there is information, the use of which is limited by the Code, that can be used by the APVMA in determining the application, and if so, the nature of that information; (h) whether that information can be used by the APVMA pursuant to consent or agreement (for example, the consent of the relevant authorising party); (i) the following information about each manufacturer of the product, to the extent that the proposed variation would affect the information, or if there is a new manufacturer: (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; (j) for a veterinary chemical product – the name, street address and licence number of the person who performs release for supply of the product; (k) for a veterinary chemical product – the licence number of each person who performs a step in the manufacture of the product in Australia; (l) if the application is of a kind that requires the provision of data or a technical assessment – 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; (m) the following information about the containers of the product, but only if those details would change in accordance with the variation proposed: (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 presentation of the product; (n) the proposed shelf life expiry period for the product (if applicable, and only if that period would change in accordance with the variation proposed); (o) the proposed in‑use shelf life for the product (if applicable, and only if the shelf life would change in accordance with the variation proposed); (p) the proposed storage conditions for the product, but only if those conditions would change in accordance with the variation proposed; (q) if the variation affects an approved label – the distinguishing number for the approved label, the pack size, and a statement as to whether the applicant seeks for the approval to be cancelled and the reason why the applicant seeks for the approval to be cancelled. (2) If there is consent or agreement for the purposes of paragraph (1)(h), the application must contain, or be accompanied by, the written consent or agreement for the use of the information by the APVMA.