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TGC meeting 24, 4 May 2004
Therapeutic Goods Committee
Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 24th Meeting held on 4 May 2004. 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 23rd Meeting of the Committee were ratified out-of-session on 26 March 2004; and
- The Summary of Key Resolutions made by the TGC at the 23rd meeting and the subsequent Information for Stakeholders - Report on Meeting has been included on the TGA website.
The Therapeutic Goods Committee NOTES:
- The gazettal of Therapeutic Goods Order No. 72 Standards for blood components; and
- Progress towards the development of the Therapeutic Goods Order:
- for manufacture of Haematopoietic Progenitor Stem Cells; and
- to prescribe the oversight of allogeneic, autologous and directed Haematopoietic Progenitor Cells.
- The Therapeutic Goods Committee AMENDS the Terms of Reference of its Subcommittee on Child-Resistant Packaging that were determined at the 22nd Meeting of the Committee in August 2003.
- The Subcommittee is to:
- Undertake a comparison of requirements for child-resistant packaging and safety packaging of therapeutic goods currently applying in Australia and New Zealand;
- Recommend requirements for child-resistant packaging and/or safety packaging to be applied upon commencement of the Trans-Tasman joint therapeutic products agency, including standards to apply to such forms of packaging and identification of substances to be packaged in this manner;
- Consider new national and international standards for child-resistant packaging, including British Standard (BS 8404:2001) Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for pharmaceutical products and their relevance and possible application in Australia and New Zealand; and
- Consider issues of concern to injury prevention agencies and health departments related to the child-resistant packaging of therapeutic goods;
- The Therapeutic Goods Committee AMENDS the composition of its Subcommittee on Child-Resistant Packaging that was determined at the 23rd Meeting of the Committee in December 2003.
- The Therapeutic Goods Committee RECOMMENDS the following composition for the expert Subcommittee on Child-Resistant Packaging:
- A Chairperson who is a Member of the Therapeutic Goods Committee and is appointed by that Committee;
- A Member with expertise in child-resistant packaging technologies;
- One or two Members with expertise in the packaging of medicines;
- One or two Members with expertise in poisons information services;
- One or two Members with expertise in injury prevention and surveillance;
- A Member with expertise in the regulation of poisons; and
- A Member with expertise in the consumer use of medicines.
- The Subcommittee is to be Chaired by Associate Professor Holley. The expert membership will be drawn from both Australia and New Zealand.
The Therapeutic Goods Committee:
- DISBANDS its Subcommittee on Medicine Labelling established in October 2003 to consider issues associated with the inclusion of manufacturer details on medicine labels; and
- RECORDS a vote of thanks to Members of the Subcommittee for their efforts and advice in consideration of this matter.
Medicine labelling - Consideration of stakeholder responses to discussion paper Medicine Label Improvements to Assist Product Recall
- In relation to facilitating medicine recalls, and after careful consideration of submissions received from a very broad range of stakeholders, the Therapeutic Goods Committee RECOMMENDS that there be no mandatory requirement for details of the manufacturers of medicines to be included on product labels.
- The Therapeutic Goods Committee concluded that the inclusion of manufacturers' details on the label would not improve the identification of medicines subject to recall. Reasons for reaching this conclusion included:
- The complexity of manufacturing processes (involvement of multiple manufacturers) for most medicines;
- The potential for increased consumer confusion and hindering of recall efforts if multiple manufacturers are included on labels (either by name or code number), or if a single manufacturer is included but this is not the manufacturer responsible for the recall;
- Medicine labels already include sufficient information to uniquely identify products subject to recall (product name, AUST R or AUST L number, batch number, expiry date and sponsor's or supplier's name and address);
- The impact and costs associated with amending labels for almost every medicine marketed in Australia;
- The impracticality of batch specific labels and the potential for the inclusion of additional information to compromise existing labelling;
- Commercial issues including risk of commercial damage to a named manufacturer if not responsible for the recall, disclosure of confidential information and potential impacts on market competition; and
- The possibility of alternative, more effective mechanisms to achieve the objective.
- The Therapeutic Goods Committee NOTED a number of suggestions from stakeholders for improvements in medicine labelling that should be given careful consideration in the development of requirements for medicine labelling under the new Trans-Tasman joint therapeutic products agency.
- The Therapeutic Goods Committee RECOMMENDS that the Therapeutic Goods Administration take steps to ensure that all sponsors comply with their obligations under therapeutic goods legislation in relation to maintaining product records in a manner that will permit batches of medicines to be tracked easily, accurately and in a timely manner in the event of a recall.
The Therapeutic Goods Committee RECOMMENDS that:
- A new expert Committee on Medicine Labelling be established to consider, and make recommendations on, standards for the labelling of medicines to be applied by the Trans-Tasman joint therapeutic products agency;
- The Committee should to report to the Therapeutic Goods Committee and the Therapeutic Products Interim Ministerial Council on the outcomes of its considerations;
- Membership of the Committee should be expertise-based and drawn from both Australia and New Zealand; and
- In its considerations, the Committee should be mindful of:
- The timeframe for commencement of the Trans-Tasman joint therapeutic products agency;
- Current labelling issues under consideration by the Therapeutic Goods Administration and/or Medsafe;
- Lead times needed by the medicines industry to implement any required label changes and the desirability of consolidating all necessary changes into a single action; and
- The needs of consumers and health professionals.
Out-of-Session recommendation for Adoption of British Pharmacopoeia 2003
The Therapeutic Goods Committee NOTES its recommendation made out-of-session in February 2004 (RESOLUTION NO. OOS2004/01) that the British Pharmacopoeia 2003 be adopted in Australia on 1 April 2004 for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989.
Status of European Pharmacopoeia Supplements taken up into the British Pharmacopoeia
The Therapeutic Goods Committee NOTES that the edition of the British Pharmacopoeia adopted under the Therapeutic Goods Act 1989 (the Act) with effect 1 April 2004 is British Pharmacopoeia 2003 and, for the purposes of the Act, this edition incorporates those amendments to monographs published in Supplements to the European Pharmacopoeia up to and including Supplement 4.7.
Consequential Amendment to Therapeutic Goods Order No. 70 Standards for Export Only Medicine
The Therapeutic Goods Committee RECOMMENDS that Therapeutic Goods Order No. 70 Standards for Export Only Medicine, as amended by Therapeutic Goods Order No. 70A, be amended to replace the reference to British Pharmacopoeia 2002 with reference to British Pharmacopoeia 2003.
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