TGC meeting 19, 8 November 2001

Meeting report

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TGC 19th meeting (8 November 2001) report (pdf,36kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 19th Meeting held on 8 November 2001. 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.

Out-of-session ratification and status of resolutions and minutes

The Therapeutic Goods Committee endorses the introduction of a process to achieve ratification of Minutes out-of-session, based on:

1. Within 20 working days of the Meeting, distribution of draft Minutes to all Members;
2. Within 10 working days, submission to the Secretariat, by Members who attended that Meeting, of comments on the draft Minutes;
3. Within 5 working days, circulation to all Members of comments received (other than typographical corrections and changes of editorial nature), details of amendments made (if any) and a copy of the amended Minutes;
4. Within 5 working days, provided that the Secretariat has received confirmation by majority of Members present at the Meeting that the Minutes as amended (point 3) are a true record of that Meeting, the Chair may sign them as a true record;
5. If objections are received to the amended Minutes, the Chair may, at his/her discretion, defer ratification of the Minutes to the next formal Meeting of the Committee.

1. TGC recommends that, at the earliest possible time, the TGA make public:
   1. an edited version of the Resolutions made by the TGC; and
   2. an edited version of the TGC ratified Minutes.
2. For the purposes of this Resolution, 'edited' means:
   1. deletion of:
      1. trade secrets and/or commercial-in-confidence information;
      2. reference to whether agreement was unanimous or not;
      3. reference to whether or not a Member was present at the time of a vote, unless it relates to a conflict of interest;
      4. any reference that will personally identify Members, unless it relates to a conflict of interest; and
      5. any other information for which public disclosure is inappropriate.
   2. in the case of a conflict of interest, the Member's name and the Committee's handling of the conflict is to be retained.

Note: A Member has the right to request disclosure of their name in relation to any item.

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Subcommittee on manufacturing principles

The TGC establishes a Subcommittee on Manufacturing Principles:

1. The Terms of Reference of the Subcommittee to be:
   • To advise the TGC on the principles to be observed in the manufacture of therapeutic goods for human use.
2. The composition of the Subcommittee to consist of the following members:
   • A member of the TGC who shall Chair the Subcommittee;
   • One nominee of the TGA;
   • A representative of each of the following industry organisations: APMA, ASMI, CHC and MIAA.
3. The Subcommittee may co-opt other members as required to advise on particular matters.
4. The Secretary of the TGC is to be the Secretary of the Subcommittee.

Adoption of British Pharmacopoeia 2001

1. The Therapeutic Goods Committee recommends the adoption of the British Pharmacopoeia 2001 on 1 December 2001 for the purposes of the editions of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989.
2. The Committee will consider out of session the adoption of Amendment 1 to British Pharmacopoeia 2001 following consultation by the TGA with the peak medicine and medical device industry groups.

Standards for ethanol - review of requirement to maintain TGO 29

The Therapeutic Goods Committee recommends that the TGA consult with stakeholders, with a view to obtaining agreement to the revocation of Therapeutic Goods Order No. 29 'Standards for Ethanol'.

Standards for export only medicines - proposed new TGO

The Therapeutic Goods Committee recommends the adoption of the Therapeutic Goods Order "Standards for Export Only Medicine" and the inclusion in this Order of the following alternate standards for medicine manufactured in Australia, or imported into Australia, for export only subject to the conditions given in the Order:

1. The British Pharmacopoeia (current edition);
2. The United States Pharmacopoeia (current edition);
3. The Japanese Pharmacopoeia (current edition); and
4. The European Pharmacopoeia (current edition).

Child resistant packaging - progress towards a new TGO

The Therapeutic Goods Committee recommends that the Subcommittee on Child-Resistant Packaging be re-convened:

1. to consider recent technical matters that have emerged regarding the proposed TGO on child-resistant packaging; and
2. to report back to the next TGC Meeting.

Harmonisation of Australian Approved Names associated with the adoption of BP 98

The TGC recommends that the TGA progress:

1. strategies for adopting the International Non-Proprietary Names that appear in the BP; and
2. provision of a transition process acceptable to industry and other stakeholders.

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