Document ID: chunk:federal_register_of_legislation:F2020C00810:reg:48:p2
Version: federal_register_of_legislation:F2020C00810
Segment Type: reg
Provision Reference: reg 48 (pt 2/2)
Character Range: 56275–57800

practice;
 (k) 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;
 (l) 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;
 (iv) details of the labelling of the product;
 (m) the proposed shelf life expiry period for the product (if applicable);
 (n) the proposed storage conditions for the product;
 (o)  safety criteria information for the product and information relevant to whether the product would meet the efficacy criteria;
 (p) if the chemical product is a veterinary chemical product and contains ingredients of a biological origin that have been, or are to be, imported into Australia—a copy of the relevant permits (or similar) for the importation of the product for the purposes of the Quarantine Act 1908 or a copy of any applications for such permits.
  (2) A document referred to in subparagraph (1)(j)(i) or (ii) may be provided electronically, but if it is, the applicant must retain a hard copy of the document for provision upon the APVMA's request.

Division 5—Application for a research permit