Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16da:p2
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16DA (pt 2/2)
Character Range: 236037–237610

to the approval; and
 (vii) is not, wholly or in part, based on (including compiled by reference to or in reliance on) any other assessment or evaluation (however described).

Conditions for 120 day period
 (2) For the purposes of paragraphs 16C(3)(a) and (b) and 16D(3)(a) and (b), the conditions are the following:
 (aa) the approval for the acceptable foreign approved medicine:
 (i) is in force; and
 (ii) was given not more than 12 months before the date of the application in relation to the evaluation;
 (a) the manufacturing site at which manufacturing steps other than labelling and release for supply are carried out for the evaluation medicine is identical to that for the acceptable foreign approved medicine;
 (b) if the evaluation medicine is manufactured in Australia—there is evidence that the medicine has been manufactured in accordance with Part 3‑3 of the Act;
 (c) if a step in the manufacture of the evaluation medicine has been carried out outside Australia—there is evidence that the manufacturing and quality control procedures used in the manufacture of the medicine are acceptable;
 (d) no additional information is required to complete the evaluation, other than:
 (i) the label and product information for the evaluation medicine; and
 (ii) the risk management plan (if any) for the evaluation medicine.

Determining foreign countries or foreign jurisdictions
 (3) The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a foreign country or a foreign jurisdiction for the purposes of this regulation.