Document ID: chunk:federal_register_of_legislation:C2024C00632:section:25:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 25 (pt 3/3)
Character Range: 216799–218945

the medicine under this section.
 (2A) An evaluation under this section of goods in relation to which a period has been prescribed under paragraph 63(2)(da) must be completed within that period.
 (2B) If therapeutic goods are exempt from the operation of Part 3‑3 or a person is exempt from the operation of that Part in relation to the manufacture of the goods, subsection (1) has effect, in relation to the goods, as if paragraph (h) were omitted.
 (2C) If a person is exempt from the operation of Part 3‑3 in relation to a step in the manufacture of therapeutic goods, subsection (1) has effect, in relation to the goods, as if the reference in paragraph (h) to Part 3‑3 were a reference to that Part to the extent that it applies to that person in relation to the manufacture of the goods.
 (2D) If:
 (a) therapeutic goods were made outside Australia; and
 (b) had the goods been made in Australia, they would have been exempt from the operation of Part 3‑3;
subsection (1) has effect, in relation to the goods, as if paragraph (g) were omitted.
 (2E) A decision for the purposes of paragraph (1)(g) may also take into account any information provided to the Secretary by a health authority of a Convention country and relating to:
 (a) the general standards of manufacturing practice of a particular manufacturer; or
 (b) the specific standards of manufacture or control adopted by a particular manufacturer in relation to particular goods.
 (2F) For the purposes of subsection (2E), a Convention country is a country that is a party to the Mutual Recognition Convention.
 (2G) Information referred to in subsection (2E) and provided in accordance with the Mutual Recognition Convention is to be treated as equivalent to information obtained as a result of an inspection under Part 3‑3 of this Act.
 (3) After an evaluation under this section of goods has been completed, the Secretary must decide:
 (a) to register the goods; or
 (b) not to register the goods.
Note: See also sections 25AA (approved product information for medicine), 25AB (registration of therapeutic goods) and 25AC (notice of decision not to register therapeutic goods).