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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.

  • 04 Sep 2019 8:39 AM | Anonymous

    A correction has been made to the listing facility to allow for the correct expression of propolis and royal jelly ingredients, and their extracts, in their ARTG listings.

    These changes will be made by the TGA for free in response to requests from sponsors to update their records before 31 March 2020. After this date, the changes will incur the standard fees.

    Details of this correction, and how to make the requests are contained in today's technical alert
  • 02 Sep 2019 1:57 PM | Anonymous

    A new consultation has been released regarding the next round of proposed changes to the Permissible Ingredients Determination. The changes are considered by the TGA to be low to negligible risk in nature, with proposed changes including label warning statements and mandatory ingredients.  Affected ingredients include boron, Withania somnifora, Vitex agnus-castus, Plantago spp, psyllium husk and some other minor amendments.

    The legislative amendment capturing the most recent changes to the Determination was registered on 29 August 2019.

    Full details can be found in today's technical alert.
  • 29 Aug 2019 5:52 PM | Anonymous

    The TGA have announced a raft of changes to listed medicines containing caffeine, including caffeine as a component of a herbal ingredient. NOTE that some of these changes are IMMEDIATE, and some have an 18-month transition period.

    All details are included in today's Technical Alert including CMA contact details if you are affected. We are currently communicating with the TGA on number of products expected to be affected by the immediate changes and next steps.

    These changes were primarily brought about by Ministerial requests to TGA and FSANZ to protect consumers from accidental caffeine over-consumption, which occurred in response to the caffeine overdose of a young man in Australia (noting that the product consumed was not expected to be a therapeutic good).
  • 27 Aug 2019 1:27 PM | Anonymous

    We are pleased to share with you an update on allowable Made in Australia claims and the Australian Made logo with regard to Australian complementary medicines.

    To read the full alert, please click here.

  • 22 Aug 2019 1:53 PM | Anonymous

    In response to CMA's advocacy on permitted indications, the Government are currently seeking multi-level policy approval for a 12 month extension of the fee-free period for changing listings to permitted indications.

    Due to the required approvals and legislative processes, it is not expected that this can be finalised before the current cut-off date of the 6 September 2019, however, if the approvals are underway, it is unlikely the TGA will switch on the fees from that date.

    Thank you members for your support to-date and we will send more information as it becomes available.

  • 21 Aug 2019 1:28 PM | Anonymous

    Changes will soon be made to the Permissible Indications Determination including
    •    addition of 4 new indications
    •    changes to 32 existing indications to clarify/correct the wording of indications and/or indication requirements, including label warning statements.
    The details of these changes are contained in today's technical alert.

  • 12 Aug 2019 4:45 PM | Anonymous

    A Liaison fee will be required for all GMP clearance applications that use Canadian Inspection Exit Notices as evidence for compliance verification.

    The 2nd GMP Forum will be held in Melbourne on Thursday 21 November 2019.

    The TGA publishes a reminder for sponsors of sports supplements to be aware of their regulatory status and obligations.

    Read more in this week's technical alert.

  • 01 Aug 2019 2:47 PM | Anonymous

    Changes to the regulation of nappy rash products will be implemented on 1 January 2020.

    CMA is a founding member of the new Naturopathic Council of Australia (NCA), a co-ordinating body to represent the naturopathic profession.

    Details of changes relevant to complementary medicines and further information about the NCA are in today's technical alert.

  • 31 Jul 2019 2:49 PM | Anonymous

    Amendments to the Therapeutic Goods Advertising Code have been registered on the Federal Register of Legislation. The amendments are minor, but primarily relax some of the requirements that were causing impediments to advertisers of complementary medicines, and are effective as of 30 July 2019.

    Details of changes relevant to complementary medicines and the highlighted changes to each section of the Code are included in today's technical alert.

  • 17 Jul 2019 2:52 PM | Anonymous

    Updated guidance has been published by the TGA to support sponsors in applying the requirements of TGOs 91and 92.

    The 2nd Annual GMP forum is open for registrations.

    Two more compositional monographs have been published by the TGA for Resveratrol and Calcified Lithothamnion species.

    For full details and links, members may view today's technical alert here.

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