Document ID: chunk:federal_register_of_legislation:C2015A00008:clause:1_12
Version: federal_register_of_legislation:C2015A00008
Segment Type: clause
Provision Reference: sch 1 cl 12
Character Range: 9749–10443

12  After subsection 70(5)
Insert:
 (5A) For the purposes of paragraph (5)(a), disregard an inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, a pharmaceutical substance if the inclusion was sought for the sole purpose of exporting the goods from Australia to address a public health problem in an eligible importing country:
 (a) in circumstances of national emergency or other circumstances of extreme urgency; or
 (b) by the public non‑commercial use of the goods.
Note: This subsection also applies in relation to an application for an extension of the term of a standard patent (see paragraph 71(2)(b)).

Meaning of pre‑TGA marketing approval