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Technical Alerts

Technical Alerts

This section contains Technical Alerts for members only - to access restricted Technical alerts member login is required.

  • 17 May 2012 9:12 PM | Anonymous

    The CHC is seeking comment from all members on the draft TGA consultation document ‘Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants). It is imperative that all members review the consultation document and make individual submission to the TGA in response to the proposed changes by Friday 25 May 2012. Provided at the following attachment are details of the major issues identified through the industry  working group meeting, which will assist you in preparing your submission.

    We also ask that you return your populated table (page 4) to Emma Burchell at by COB, Wednesday 23rd of May.  Please click here to view the Member Alert

  • 07 May 2012 2:28 PM | Anonymous
    The CHC is seeking industry participants to provide feedback on the functionality, presentation and suitability of the
    publicly accessible Database of Adverse Event Notifications - prototype database. A trial is set to take place this week between Tuesday 8 May and Monday 14 May.

    If you would like to participate in the testing phase please send your preferred email address and
    contact number to Emma Burchell at by no later than Wednesday 9 May. A
    URL and password will be emailed to the first 6 people to nominate themselves, allowing access to
    the prototype database under section 61 of the Therapeutic Goods Act 1989.
    For more information click here.
  • 02 May 2012 11:39 AM | Anonymous
    The CHC is seeking comment from you on the draft document ‘Evidence Required to Support
    Indications for Listed Medicines (excluding sunscreens and disinfectants)
    ’, (the evidence document).
    Comments can be sent to Emma Burchell at by 16 May 2012.

    Click Here to read more
  • 28 Mar 2012 10:19 AM | Anonymous

    Please be advised that the Office of Complementary Medicines (OCM) has made 17 new specific names for metal
    amino acid chelates available for use in the Electronic Listing Facility (ELF).

    More information and a list outlining the new specific names can be found here.

  • 06 Mar 2012 2:34 PM | Anonymous
    A legislative change now provides Sponsors with additional time for payment and to seek LVT exemptions on
    new products.

    For this and more information on Low Value Turnover exemptions-due dates and forms,  please click here.
  • 22 Feb 2012 9:24 AM | Anonymous
    The CHC welcomes Dr Brian Richards as the Acting Nation Manager of the TGA, while a permanent position is said
    to be advertised early this year.

    Click here to read more.....

  • 20 Feb 2012 2:16 PM | Anonymous
    The CHC is seeking comment from you in relation to the Foods Standards Australia New Zealand draft Nutrition,
    Health and Related Claims Standard. Comments on whether the further revision of the text undertaken since 2009,
    accurately reflects the regulatory intent and provides clarity, enforceability and 'user-friendliness' are sought.

    Comments can be sent to the Regulatory Affairs Team at:  by Friday 9th March 2012. 

    The CHC call for comment and links to the FSANZ consultation paper can be located here.
  • 13 Feb 2012 11:03 AM | Anonymous
    For information on changes to the Electronic Listing System with regards to the validation rules for Strychnos spp.
    and Nux Vomica, please click here.
  • 10 Feb 2012 11:39 AM | Deleted user

    The TGA is seeking comments from interested parties on the proposed advisory statements for cough and cold medicines for use in children.

    Click here to read more.

  • 31 Jan 2012 5:13 PM | Anonymous
    The TGA is seeking expressions of interest for a number of positions on expert advisory committees.
    Expressions of interest close on the 29th February 2012.

    Click here for more detail.

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