57Information in the application

57 Information in the application

The application must contain the following information: (a) the applicant details; (b) if the applicant already holds a licence – the number assigned to that licence by the APVMA; (c) the reason for the application; (d) the street address of the primary premises at which the steps in the manufacture of chemical products to which the application relates would be carried out; (e) the street addresses of any other premises controlled by the applicant (secondary premises) at which those steps would be carried out; (f) the street addresses of any other premises controlled by the applicant (tertiary premises) at which starting materials, work in progress or manufactured products to which the application related would be stored; (g) the types of products manufactured at the primary premises, secondary premises and tertiary premises, in the manner provided for by the relevant approved form; (h) the steps in the manufacture of chemical products to be carried out at the primary premises and each of the secondary and tertiary premises (in the manner provided for by the relevant approved form); (i) if the application relates to the manufacture of biological or immunobiological veterinary chemical products – a list of the organisms used in the production areas or for production purposes; (j) for each chemical product manufactured or proposed to be manufactured (wholly or partly): (i) the name of the product; and (ii) any distinguishing number for the registration of the product or permit in relation to the product; and (iii) the person who is, or is proposed to be, the holder of the product’s registration; and (iv) the steps in the manufacture of the product which the applicant proposes to carry out; and (v) the status of the product under the Code (for example, whether it is registered, awaiting a decision on registration, or is supplied pursuant to a permit); (k) whether any of the chemical products to which the application relates contain penicillins, cephalosporins, other antibiotics, cytotoxic medicines, hormones, steroids, or chemicals to which any schedule to the Standard for the Uniform Scheduling of Medicines and Poisons applies; (l) if the application relates to veterinary chemical products – any chemical products that are not veterinary chemical products and are manufactured at the primary, secondary or tertiary premises, and whether those other products are manufactured using the same equipment used for the veterinary chemical products; (m) for each laboratory or manufacturer involved in the analysis and testing of any 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).