You are here
TGC meeting 28, 24 January 2006
Therapeutic Goods Committee
Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 28th Meeting held on 24 January 2006. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be available in the form of an edited Report following ratification of the Minutes by the Committee.
The Therapeutic Goods Committee NOTES that:
- the Minutes of the 27th Meeting of the Therapeutic Goods Committee held on 9 June 2005, were ratified out-of-session as a true and accurate record of that Meeting; and
- the documents Summary of Key Resolutions and Information for Stakeholders - Report on Meeting have been published on the TGA website.
The Therapeutic Goods Committee:
- PROPOSES the revocation of Therapeutic Goods Order No. 8 Standards adopted from the British Pharmaceutical Codex 1973 (TGO 8);
- RECOMMENDS that the Therapeutic Goods Administration seek comment from stakeholders, including sponsors and industry associations, on the implications of revocation for currently listed or registered products; and
- AGREES to consider this stakeholder comment at its next Meeting in order to finalise a recommendation on the matter.
The Therapeutic Goods Committee RECOMMENDS consideration of the consultation responses on adoption of the British Pharmacopoeia 2005 out-of-session, following close of the consultation period on 24 February 2006, with a view to adoption of the British Pharmacopoeia 2005 as the edition of that document defined under the Therapeutic Goods Act 1989.
Change to Conformity Assessment Standard Order No. 1 Quality Management Systems and Quality Assurance Techniques - for information.
The Therapeutic Goods Committee NOTES the registration of Conformity Assessment Order No. 1 of 2005 - Replacement of Conformity Assessment Standard Order No. 1: Conformity Assessment Standard for Quality Management and Quality Assurance Techniques made on 20 February 2003.
Update on the review of the regulatory framework for hospital, household and commercial disinfectants
The Therapeutic Goods Committee NOTES:
- the outcomes of the TGA consultation on proposed amendments to the regulation of hospital, household and commercial disinfectants:
- namely that there is support for the proposal to make currently registrable hospital, household and commercial grade disinfectants (with specific claims) listable; but
- that there have been concerns raised about the appropriateness of the TGA proposal for the regulation of lower risk hospital, household and commercial grade disinfectants (without specific claims); and
- that the TGA and NICNAS will work together to develop a proposal for implementing new regulatory requirements for hospital, household and commercial disinfectants that explores the possibility of the TGA retaining responsibility for regulating hospital grade disinfectants while household/commercial grade disinfectants and sanitisers are excluded from TGA regulatory requirements.
|Therapeutic Goods Committee, 28th Meeting (January 2006) (pdf)||53KB|