THERAPEUTIC GOODS ACT 1989 - SECT 61 Release of information
THERAPEUTIC GOODS ACT 1989 - SECT 61
Release of information"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).
(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 national regulatory authority of another country, being an authority that has national responsibility relating to therapeutic goods, therapeutic goods information relating to:
(a) recommendations of advisory committees on therapeutic goods supplied in or proposed for supply in Australia, and any conditions that are or will be applicable to that supply; or
(b) decisions on the registration or listing, or the suspension or cancellation of the registration or listing, of therapeutic goods; or
(baa) decisions on the inclusion of biologicals in the Register, or the suspension or cancellation of the inclusion of biologicals in the Register; or
(ba) decisions on the inclusion of kinds of medical devices in the Register, or the suspension or cancellation of the inclusion of kinds of medical devices in the Register; or
(c) the withdrawal from supply in Australia of therapeutic goods and the reasons for that action; or
(d) the licensing status of Australian manufacturers of therapeutic goods and their compliance with the manufacturing principles; or
(e) proceedings of committees established under the regulations; or
(f) the issue of, imposition of conditions on, or revocation of, conformity assessment certificates;
for use in the performance of those functions or for furthering international co - operation in the regulation of therapeutic goods.
(4A) The Secretary may release to:
(a) an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods, health or law enforcement; or
(b) a national regulatory authority of another country that has national responsibility relating to therapeutic goods, health or law enforcement; or
(ba) an international organisation that has a function relating to therapeutic goods, health or law enforcement;
therapeutic goods information relating to one or more of the following:
(c) notifications received under section 42T;
(d) action taken by the Secretary under Part 5 - 3;
(da) action taken by the Secretary under section 30EA (about notification and recall of therapeutic goods);
(db) action taken by the Secretary under section 32HA (about notification and recall of biologicals);
(dc) action taken by the Secretary under section 41KA (about notification and recall of medical devices);
(e) contraventions, or possible contraventions, of Part 5 - 2 or Part 5 - 3;
(f) any cases, or possible cases, of actual or potential tampering with therapeutic goods;
(fa) any cases, 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;
(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 information:
(a) the release of which is necessary to ensure the safe use of particular therapeutic goods; or
(b) relating to the reasons for the withdrawal of therapeutic goods from supply in Australia.
(8) Subject to sections 25A and 26AF, therapeutic goods information provided to the Department in relation to a matter may:
(a) be used by the Department in the consideration of another matter within its functions relating to therapeutic goods; and
(b) be provided to a committee appointed to advise the Minister or the Secretary on matters relating to therapeutic goods, including a committee of the National Health and Medical Research Council.
Note: The Secretary may also disclose therapeutic goods information provided to the Department to the Chief Executive Medicare for the purpose of certain data - matching: see section 132C of the National Health Act 1953 .
(8A) Regulations prescribing fees in respect of applications for information under the regulations:
(a) may include provision for the payment of deposits on account of such fees; and
(b) may provide for fees that take into account the time spent by officers of the Department in:
(i) searching for or retrieving information; or
(ii) making, or doing anything related to the making of, a decision on an application; and
(c) may provide for fees that take into account the direct costs incurred by the Commonwealth in making available an officer to supervise the inspection by an applicant of any document containing information to which an application relates.
(8C) If, under the regulations, a person is liable to pay a fee in respect of an application for information, the Secretary must notify the person, in writing, accordingly, and must give to the person, together with that notification, a statement setting out the basis on which the amount of that fee is calculated.
(9) Despite subsection 14(2) of the Legislation Act 2003 , an instrument under subsection (5AB) or (5D) of this section may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
(10) Nothing in this or any other Act requires the Secretary to disclose to any person, court or tribunal information referred to in subsection 25(2E) (including as that subsection applies because of subsection 32DE(2) or 32EB(3)) or 26(2D) if the disclosure would constitute a breach of the Mutual Recognition Convention.
(11) This section (except subsection (10)) has effect subject to the Freedom of Information Act 1982 .
(12) The subsections of this section permitting the release of information have effect independently of each other.
(13) The Secretary is not required to observe any requirements of the natural justice hearing rule in relation to:
(a) releasing information under subsection (5C) if:
(i) the release of the information is in the interests of public health or safety; or
(ii) the information relates to the safety of one or more therapeutic goods; or
(b) releasing information under any other provision of this section.
(14) Subsection (13) is not to be taken to imply that the natural justice hearing rule applies in relation to any other exercise of power under this Act (including this section) or the regulations.
(15) For the purposes of subparagraph (13)(a)(i), the release of information is not in the interests of public health or safety if the information:
(a) relates to the quality or efficacy of therapeutic goods; and
(b) does not relate to the safety of the therapeutic goods.