TGC meeting 22, 11 August 2003

Meeting report

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TGC 22nd meeting (11 August 2003) report (pdf,74kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 22nd Meeting held on 11 August 2003. 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.

TGC subcommittees

1. The Therapeutic Goods Committee establishes a Subcommittee on Blood and Tissues.

2. The Subcommittee is to provide a draft Therapeutic Goods Order specifying standards for:

   • Haematopoietic stem cells harvested from placental cord blood; and
   • Haematopoietic stem cells harvested from sources other than placental cord blood,

   for consideration by the Therapeutic Goods Committee at its next Meeting.

3. The Subcommittee is to be Chaired by Associate Professor Rawlinson and have an appropriate membership drawn from experts in this field.
4. The Therapeutic Goods Committee establishes a Subcommittee on Child-Resistant Packaging.
5. The Subcommittee is to advise the Therapeutic Goods Committee on:
   • Forms of child-resistant packaging not covered by the existing Therapeutic Goods Orders;
   • The newly introduced British Standard (BS 8404:2001) Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for pharmaceutical products and other relevant international standards; and
   • Issues of concern to injury prevention agencies or health departments related to the child-resistant packaging of therapeutic goods.
6. The Subcommittee is to be Chaired by Associate Professor Holley and have an appropriate expert membership.

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Amendment to Therapeutic Goods Order No. 69 General requirements for labels for medicines

1. The Therapeutic Goods Committee notes that the new Therapeutic Goods Administration document, Mandatory Advisory Statements for Medicine Labels, will contain the warning statements transferred from the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP), as well as advisory statements from other sources such as the Therapeutic Goods Regulations.
2. The Therapeutic Goods Committee recommends the following amendments to Therapeutic Goods Order No. 69 General requirements for labels for medicines, and that these amendments be implemented with effect from 1 July 2004:
   
    
   • Amend the definition of 'warning statements' contained in clause 2(1) Interpretation of Therapeutic Goods Order No. 69, to read
     
     'warning statements' means:
     1. any labelling requirements specified in the Mandatory Advisory Statements for Medicine Labels;
     2. any warning statements specified in the standard that applies to the goods;
     3. a warning statement where incorrect route or method of administration may be hazardous;
     4. any warnings required by the Secretary, Department of Health and Ageing to be included as a condition of Registration/Listing in relation to the goods;

   • Insert, immediately before clause 1 Application and exemptions, the following heading and paragraphs:
     
     Introduction
     
     The purpose of a medicine label is to provide information about the product such as its identity, potency, content, storage, expiry date, registration status and distributor. Medicine labels also include other information not required by the Order, but which may be required by other legislative instruments or for commercial purposes. These include items such as signal headings (eg. prescription only, pharmacist only), bar codes and sponsor's logos.
     
     For non-prescription medicines, the aim is that the information on the label is presented in such a way that consumers can:

     1. choose an appropriate medicine on their own;
     2. use the medicine safely and effectively;
     3. readily find the information they need, understand it and act on it; and
     4. access further information, if they want to know more about the medicine.

     Although there may be various means of achieving the aim stated above, products with labels that have been designed in accordance with the industry Code of Practice entitled [title of the industry code to be inserted]¹ and published by [publication details to be inserted]² will be taken to achieve this aim.
     
     The mandatory aspects of this Order for all medicines are contained in clauses 1- 7 inclusive and the Schedules to the Order.

¹ Expected title is "Designing Medicine Labels for People - A Code of Practice for Developing Usable Labels for Non-Prescription Medicines"
² To be published by the Communication Research Institute of Australia

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Adoption of standards for tamper-evident packaging of therapeutic goods

The Therapeutic Goods Committee recommends that the publication Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods³ be adopted through a Therapeutic Goods Order as a standard in Australia for therapeutic goods, with effect from 1 January 2004 and with a 12-month implementation period from 1 January 2004 for full compliance.

³ Available on the TGA website at www.tga.gov.au

Review of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56)

1. The Therapeutic Goods Committee:
   • Notes those issues raised by stakeholders in relation to the proposed review of Therapeutic Goods Order No. 56 (TGO 56) General standard for tablets, pills and capsules; and
   • Establishes a Subcommittee on General Standards for Tablets, Pills and Capsules to consider those issues in detail and the continued relevance of a general standard for tablets, pills and capsules.

2. The Subcommittee is to undertake a review of TGO 56, taking into account:

   • Changes in the British Pharmacopoeia since TGO 56 was gazetted;
   • Characteristics of, and regulatory arrangements for, prescription, non-prescription and complementary medicines; and
   • Relevant international standards, and

   provide a report to the first meeting of the Therapeutic Goods Committee in 2004.

3. The Subcommittee is to be Chaired by Professor O'Donnell and have an appropriate expert membership, supplemented with relevant industry representation.

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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 be amended to replace the reference to United States Pharmacopeia 25th edition with reference to United States Pharmacopeia 26th edition.

Standard for haematopoietic stem cell (HSC) products

The Therapeutic Goods Committee notes:

• Progress in the development of a therapeutic goods order as a standard in Australia for haematopoietic stem cells; and
• That the draft Therapeutic Goods Order will be referred to the next meeting of the Committee for consideration.

Update on medical device standards

The Therapeutic Goods Committee notes:

• The Medical Device Standards Orders⁴ and Conformity Assessment Standards Orders⁵ gazetted to date; and
• Those EN, ISO and IEC standards on medical devices adopted as Australian Standards⁶ by Standards Australia.

⁴ Available on TGA website at Standards orders and medical devices
⁵ Available on TGA website at Standards orders and medical devices
⁶ See Attachment 1 and Attachment 2

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Attachment 1: Documents adopted as Australian Standards - Round 1 - June 2002

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Attachment 2: Documents adopted as Australian Standards - Round 2 - June 2003

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