Document ID: chunk:federal_register_of_legislation:F2020C00810:reg:57:p2
Version: federal_register_of_legislation:F2020C00810
Segment Type: reg
Provision Reference: reg 57 (pt 2/3)
Character Range: 70065–72887

of the chemical products to which the application relates – the following information:
 (i) the name and address of the laboratory or manufacturer;
 (ii) the number assigned by the APVMA to any relevant licence held by the laboratory or manufacturer;
 (iii) the products dealt with by the laboratory or manufacturer;
 (iv) the analysis or testing, or assaying, performed by the laboratory or manufacturer;
 (n) for each manufacturer who, under contract with the applicant, carries out or would carry out steps in the manufacture of a chemical product to which the application relates:
 (i) the name and address of the manufacturer; and
 (ii) the number assigned by the APVMA to any relevant licence held by the manufacturer; and
 (iii) the products dealt with by the manufacturer pursuant to the contract; and
 (iv) the steps in the manufacture of those products carried out pursuant to the contract;
 (o) for each person other than the applicant who performs release for supply of a chemical product to which the application relates:
 (i) the name and address of the person; and
 (ii) the number assigned by the APVMA to any relevant licence held by the person; and
 (iii) the products dealt with by the person;
 (p) if a primary, secondary or tertiary premises is licenced or certified (or similar) for compliance with good manufacturing practice or relevant recognised quality standard by the Therapeutic Goods Administration or the National Association of Testing Authorities, Australia:
 (i) whether the holder of that licence or certification is the same as the proposed holder of the licence being applied for; and
 (ii) the extent to which the relevant products, and steps in the manufacture of those products, to which the application relates are the same as the products and steps covered by that licence or certification and have been the subject of inspections by the relevant licensing or certifying authority;
 (q) whether the applicant consents to the Therapeutic Goods Administration providing the APVMA with information relevant to their inspections of premises to which paragraph (p) applies;
 (r) the number of permanent and casual employees, and their shifts per day, engaged in production, in quality control, in storage and distribution, and in technical and engineering support services;
 (s) nominations of a person responsible for production and a person responsible for quality control pursuant to the licence sought and, in each case, information about their qualifications and experience;
 (t) the applicant declaration;
 (u) whether paragraph 123(1)(e) of the Code applies in relation to any of the persons mentioned in subparagraphs 123(1)(e)(i) to (iii);
 (v) whether paragraph 123(1)(f) of the Code applies in relation to any of the persons mentioned in subparagraphs 123(1)(f)(i) to (iii).