Document ID: chunk:federal_register_of_legislation:F2025C00036:reg:16gj
Version: federal_register_of_legislation:F2025C00036
Segment Type: reg
Provision Reference: reg 16GJ
Character Range: 262702–263310

16GJ  Determination of competent regulatory authority of a foreign country or foreign jurisdiction in relation to evaluation of applications
  The Secretary may, in writing published on the Therapeutic Goods Administration website, determine a competent regulatory authority of a foreign country or a foreign jurisdiction in relation to the evaluation of the following medicine applications:
 (a) an IN1 application;
 (b) an IN2 application;
 (c) an IN3 application;
 (d) an L(A)2 application;
 (e) an RCM2 application;
 (f) an RCM3 application;
 (g) an RCM4 application.

Part 3B—Designated orphan drugs