Document ID: chunk:federal_register_of_legislation:C2024C00632:section:61:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 61 (pt 3/5)
Character Range: 1134708–1137707

or possible cases, of counterfeit therapeutic goods;
 (g) information relating to an offence committed against this Act, or alleged to have been committed against this Act, involving therapeutic goods;
 (h) information relating to the contravention of a civil penalty provision, or the alleged contravention of a civil penalty provision, involving therapeutic goods;
 (i) a breach of a requirement of this Act or the regulations.
 (4B) The release of therapeutic goods information mentioned in paragraphs (4A)(g), (h) and (i) is not taken, for the purposes of paragraph 6.2(b) of Australian Privacy Principle 6, to be authorised by this Act.
 (5) The Secretary may release to a national regulatory authority of another country, or an international organisation, being another country or an organisation with which the Commonwealth has cooperative arrangements relating to the assessment or regulation of therapeutic goods, the following information the release of which is consistent with those arrangements:
 (a) therapeutic goods information;
 (b) information relating to Australian conformity assessment bodies and either to conformity assessment body determinations or to certification‑related activities of Australian conformity assessment bodies.
 (5AA) The Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection (5AB) therapeutic goods information of a kind specified under that subsection for a purpose specified under that subsection.
 (5AB) For the purpose of subsection (5AA), the Minister may, by legislative instrument, specify one or more of the following:
 (a) a person, body or authority;
 (b) kinds of persons, bodies or authorities;
 (c) kinds of therapeutic goods information;
 (d) purposes.
 (5A) The Secretary may release to the public therapeutic goods information relating to any decision or action taken under this Act or the regulations.
 (5B) The release of therapeutic goods information under subsection (5A) is not taken, for the purposes of paragraph 6.2(b) of Australian Privacy Principle 6, to be authorised by this Act.
 (5C) The Secretary may release to the public therapeutic goods information of a kind specified under subsection (5D).
 (5D) The Minister may, by legislative instrument, specify kinds of therapeutic goods information for the purpose of subsection (5C).
 (6) The Secretary may release to a person, on application by that person, therapeutic goods information of a kind identified in the regulations relating to:
 (a) therapeutic goods included in the Register; or
 (b) therapeutic goods in relation to which an application for registration, listing or inclusion in the Register has been made.
 (6A) Regulations made for the purposes of subsection (6) may:
 (a) relate to therapeutic goods generally or to a class of such goods; and
 (b) authorise the release of therapeutic goods information to persons generally or to a class of persons.
 (7) The Secretary may release therapeutic goods