Therapeutic Goods Information (Sharing of Committee Information) Specification 2014
Therapeutic Goods Act 1989
I, JOHN SKERRITT, a delegate of the Minister for Health, make this Specification under subsection 61(5AB) of the Therapeutic Goods Act 1989.
11th April 2014
Delegate of the Minister for Health
1 Name of Specification
This Specification is the Therapeutic Goods Information (Sharing of Committee Information) Specification 2014.
This Specification commences on the day after it is registered.
In this Specification:
Act means the Therapeutic Goods Act 1989.
Committee means any of the committees established under Divisions 1-1EB of Part 6 of the Regulations.
Regulations means the Therapeutic Goods Regulations 1990.
TGA means the Therapeutic Goods Administration, which is part of the Department of Health.
4 Therapeutic goods information, persons and purposes
The kinds of therapeutic goods information, persons, bodies and purposes, mentioned in Schedule 1 are specified under subsection 61(5AB) of the Act, for the purposes of subsection 61(5AA) of the Act.
Schedule 1 Specified kinds of therapeutic goods information, persons, bodies and purposes
The following kinds of therapeutic goods information, persons, bodies and purposes:
Note: The following specified kinds of therapeutic goods information may be released by the Secretary under subsection 61(5AA) of the Act to the following specified bodies and kinds of persons, for the following specified purposes.
1. Therapeutic goods information:
The following kinds of therapeutic goods information, being information that relates to the Committees and that is held by the TGA:
The advice and/or recommendations provided by a Committee to the Minister or the Secretary in relation to a matter, under the Regulations.
Committee agenda papers
Committee meeting agenda papers. The agenda papers may include the name and contact details of committee members and TGA staff.
Minutes and Outcomes
Minutes of Committee meetings, and/or brief descriptions of any outcomes arising from such meetings. The outcomes (referred to as the meeting statement) will include the contact details of TGA staff for bodies to obtain further information. The minutes will list attending members by name only and attending TGA staff by name and position.
2. Persons and bodies:
(a) Advisory Committee on Biologicals (ACB);
(b) Advisory Committee on Complementary Medicines (ACCM);
(c) Advisory Committee on Medical Devices (ACMD);
(d) Advisory Committee on Non-prescription Medicines (ACNM);
(e) Advisory Committee on Prescription Medicines (ACPM);
(f) Advisory Committee on the Safety of Medical Devices (ACSMD);
(g) Advisory Committee on the Safety of Medicines (ACSOM);
(h) Advisory Committee on the Safety of Vaccines (ACSOV);
(i) Therapeutic Goods Committee (TGC);
(j) the Therapeutic Goods Subcommittee on Biologicals;
(k) Pharmaceutical Sub Committee (PSC);
(l) Orthopaedic Sub Committee (OSC);
(m) Advisory Committee on Medicines Scheduling (ACMS);
(n) Advisory Committee on Chemicals Scheduling (ACCS);
(o) Australian Therapeutic Goods Advisory Council (ATGAC);
(p) Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR);
(q) Pharmaceutical Benefits Advisory Committee (PBAC);
(r) Drug Utilisation Sub Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee;
(s) Medical Services Advisory Committee (MSAC);
(t) Prostheses List Advisory Committee (PLAC);
(u) National Centre for Immunisation Research and Surveillance (NCIRS);
(v) National Immunisation Committee (NIC);
(w) Australian Technical Advisory Group on Immunisation (ATAGI);
(x) the Panel of Clinical Experts for neurosurgical, plastic and reconstructive, ear/nose/throat, and general and miscellaneous prostheses;
(y) the Cardiac Prostheses Clinical Advisory Group;
(z) the Cardiothoracic Prostheses Clinical Advisory Group;
(aa) the Hip Prostheses Clinical Advisory Group;
(bb) the Knee Prostheses Clinical Advisory Group ;
(cc) the Ophthalmic Prostheses Clinical Advisory Group ;
(dd) the Specialist Orthopaedic Clinical Advisory Group for orthopaedic prostheses excluding hip, knee and spinal prostheses;
(ee) the Spinal Prostheses Clinical Advisory Group;
(ff) the Urogenital Prostheses Clinical Advisory Group;
(gg) the Vascular Prostheses Clinical Advisory Group; and
(hh) employees, members or agents of the entities mentioned above in (a) – (gg).
To facilitate the sharing and considering of information in the interest of public health and safety, including in particular the sharing and considering of information relating to the safety and (where relevant) efficacy or performance of therapeutic goods.
1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au