61Licence conditions—general

#### 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 are recorded in writing; and (c) must ensure that the contractor maintains any records that, under the licence condition imposed by subregulation (3), the licence holder would be required to maintain if the licence holder performed the step; and (d) must ensure that: (i) the premises at which the contractor performs the step; and (ii) the records referred to in paragraphs (b) and (c); are made accessible to a person appointed by the APVMA to inspect the operations of the licence holder. (7A) The holder of a licence may sub‑contract the manufacture of the chemical products only to: (a) a manufacturer, or laboratory, licensed by the APVMA to perform a step in the manufacture of the chemical products; or (b) a manufacturer or laboratory located outside Australia that the APVMA has determined complies with a standard of manufacture comparable to the manufacturing principles and the Australian GMP Code. (8) If directed by the APVMA CEO, the holder of a licence must: (a) undergo an audit by an APVMA inspector, or another person authorised in writing by the APVMA (an auditor), of the facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products (a GMP audit); and (b) demonstrate to the satisfaction of the APVMA that the holder is complying with the following conditions of the licence: (i) any conditions imposed on the licence under subsections 126(1) and (2) of the Code; (ii) the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition; (iii) any of the conditions mentioned in subregulations (3) to (7A) to which the licence is subject. (8A) For the purposes of a GMP audit, the holder of the licence: (a) must give the auditor access to all facilities, equipment, systems, processes, procedures and personnel used in the manufacture of the chemical products, and any information relevant to the GMP audit; and (b) must not conceal or withhold relevant information from the auditor. (8B) If the audit identifies a non‑conformance by the holder of the licence that, in the auditor’s opinion, is a critical non‑conformance, the holder must notify the APVMA in writing of the critical non‑conformance within 3 working days of being told of the critical non‑conformance by the auditor. (8C) Following a GMP audit of the holder of a licence, the holder must: (a) within the period determined by the APVMA, give to the APVMA: (i) the original audit report, signed by the auditor, and any associated audit report supplements; and (ii) details of the corrective action the holder proposes to take in relation to any non‑conformance identified in the audit report; and (iii) a proposed period for taking the corrective action; and (b) implement the corrective action within the period agreed to or specified by the APVMA; and (c) give to the APVMA evidence demonstrating that the holder is complying with the following conditions of the licence: (i) any conditions imposed on the licence under subsections 126(1) and (2) of the Code; (ii) the condition mentioned in paragraph 126(4)(a) of the Code, if the licence is subject to that condition; (iii) any of the conditions mentioned in subregulations (3) to (7A) to which the licence is subject. (9) If the holder of a licence: (a) changes his, her or its name; or (b) being a corporation that has amalgamated with another corporation, carries on business under a name that is different from the name of the holder stated on the licence; the holder must give notice in writing to the APVMA of the new name, and the circumstance giving rise to it, within 3 months after the occurrence of the circumstance. (10) If a body corporate that is the holder of a licence becomes a Chapter 5 body corporate, within the meaning of the Corporations Law, the person responsible for its administration must notify the APVMA, in writing, that the body corporate has become a Chapter 5 body corporate within 3 months after that occurrence.