Document ID: chunk:federal_register_of_legislation:F2020C00810:reg:12
Version: federal_register_of_legislation:F2020C00810
Segment Type: reg
Provision Reference: reg 12
Character Range: 19877–22183

12  General technical information
 (1) The application must contain the following information:
 (a) 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;
 (b) 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;
 (c) if the product is a veterinary chemical product—the licence number of each person who performs a step in the manufacture of the product in Australia;
 (d) if the product is a veterinary chemical product—the name, street address and licence number (for facilities in Australia) of the person who performs release for supply of the product, whether the manufacture of the product occurs in Australia or overseas;
 (e) 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; and
 (iv) details of the presentation of the product;
 (f) the proposed shelf life expiry period for the product (if applicable);
 (g) the proposed in‑use shelf life for the product (if applicable);
 (h) the proposed storage conditions for the product;
 (i) if the product is a veterinary immunobiological product – for each of the product's active constituents:
 (i) its common name and reference; and
 (ii) its source or history of isolation; and
 (iii) its identity (strain, genus, species and serotype or biotype); and
 (iv) its unique identifier or descriptor; and
 (v) its master seed code and passage level; and
 (vi) its working seed code and passage level.