Document ID: chunk:federal_register_of_legislation:C2024C00632:section:61:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 61 (pt 1/5)
Character Range: 1129228–1132229

61  Release of information
 (1) In this section:
therapeutic goods information means information in relation to therapeutic goods that is held by the Department and relates to the performance of the Department's functions (including functions relating to the EC Mutual Recognition Agreement, the EFTA Mutual Recognition Agreement or the Australia‑UK Mutual Recognition Agreement).
vaping goods information means information in relation to vaping goods that is held by the Department and relates to the performance of the Department's functions.
 (2) The Secretary may:
 (a) release to the World Health Organisation therapeutic goods information relating to:
 (i) notifications concerning therapeutic goods the consumption or supply of which in Australia has been prohibited or severely restricted, or relating to the reasons for that action; or
 (ii) the licensing status of Australian manufacturers of therapeutic goods and their compliance with the manufacturing principles; or
 (iii) the content of reports to the Department concerning adverse effects of therapeutic goods; or
 (iv) the issue of, imposition of conditions on, or revocation of, conformity assessment certificates;
  for use in the development of policies relating to the regulation of therapeutic goods or for the provision of information to regulatory authorities of member countries of the World Health Organisation; or
 (b) release, in confidence, therapeutic goods information to the World Health Organisation, being information concerning proceedings of committees established under the regulations.
 (3) The Secretary may release to an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods, therapeutic goods information relating to:
 (a) reported problems and complaints concerning therapeutic goods, the Department's investigation of those problems and complaints and any action that the Department has taken or proposes to take in relation to those problems and complaints; or
 (b) reports of inspections conducted under this Act or the regulations; or
 (c) decisions to revoke or suspend, or not to issue, licences for the manufacturing of therapeutic goods; or
 (d) conditions of licences; or
 (e) reports of the testing of samples of therapeutic goods; or
 (f) the issue of, imposition of conditions on, or revocation of, conformity assessment certificates;
for use in the performance of those functions.
 (3A) The Secretary may release information obtained in response to a notice under section 31A, 31AA, 31B, 31BA, 32JE, 32JF, 32JG, 32JH, 41AB, 41JCA, 41JD, 41JE or 41JF to:
 (a) an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods; and
 (b) the body in a State or Territory responsible for the registration of medical practitioners in that State or Territory; and
 (c) the body in a State or Territory responsible for the registration of pharmacists in that State or Territory.
 (4) The Secretary may release to a