Document ID: chunk:federal_register_of_legislation:F2024C00959:reg:61:p1
Version: federal_register_of_legislation:F2024C00959
Segment Type: reg
Provision Reference: reg 61 (pt 1/3)
Character Range: 148286–151004

61  Licence conditions—general
 (1) For the purposes of paragraph 126(4)(b) of the Code (which deals with conditions in licences), the following subregulations set out conditions to which each licence to manufacture chemical products is subject.
 (2) A holder of a licence must display publicly, at the premises to which the licence relates, a copy of the licence and of any notice issued by the APVMA imposing, varying or removing the conditions applicable to the licence.
 (3) A holder of a licence must make records showing:
 (a) the materials used in the manufacture of the chemical products, the supplier and quantities of the materials used and details of the tests performed on those materials; and
 (b) the procedures and controls employed in the manufacture of the chemical products, including the results of tests carried out during the processing of the chemical products; and
 (c) details of the tests performed on the chemical products and the results of those tests; and
 (d) the stability studies (if any) that validate the recommended shelf life and appropriate storage conditions of the chemical products;
 (e) any complaint or product failure in relation to the chemical products, and the investigations and actions undertaken in relation to the complaint or product failure.
 (3A) The holder of a licence must manufacture the chemical products in accordance with:
 (a) the manufacturing principles; and
 (b) the Australian GMP Code.
 (4) If the chemical products are produced in identifiable batches, the holder of the licence must assign a batch number to each batch of the finished products.
 (5) A holder of a licence must keep at the premises to which the licence relates:
 (a) the records specified in subregulation (3); and
 (b) if it is not unreasonable in the circumstances—a sample from each batch of the finished products;
for at least 12 months after the expiry date of the products to which they relate or, if there is no expiry date, for at least 6 years after the date on which the manufacture of the products was completed.
 (6) The holder of the licence must ensure that a person nominated by the holder as having control of the production of the chemical products or of the quality control measures that are to be employed in the manufacture of the products maintains that control.
 (7) If a licence allows a person other than the licence holder (in this subregulation called the contractor) to perform a step of a kind set out in paragraph 59A(a) in the manufacture of a chemical product, the licence holder:
 (a) must supervise the performance of that step; and
 (b) must ensure that the respective responsibilities of the contractor and the licence holder in relation to the step