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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.

  • 27 Sep 2019 12:25 PM | Anonymous

    The legislative amendment to the Therapeutic Goods Regulations to extend the fee free period for listed complementary medicine sponsors has been signed into effect by the Governer-General. The fee for changing existing listings to permitted indications has been turned off in the TGA listing system. No fee is payable if the listing is amended by the end of 5 March 2021.

    If you have a paid for an application to change an existing listing to permitted indications between 6 September and today, you are eligible for a refund. It will assist the TGA to find and process your refund if you email complementary.medicines@health.gov.au with the application ID and invoice number.

  • 24 Sep 2019 3:04 PM | Anonymous

    In 2014, the TGA examined cases of allergy and anaphylaxis regarding Andrographis paniculata ('Andrographis'), and published a safety alert in 2015. At that time, industry supported the introduction of a warning statement for this herb with adequate transition time, however, a warning statement was not implemented by the TGA.

    Additional cases of allergy and anaphylaxis have been reported since 2015, and the TGA have signalled that they are intending to require a new allergy and anaphylaxis label warning statement for immediate implementation in mid-October (2019), for any Andrographis medicine that is 'released for supply' from the date of the upcoming October Permissible Ingredients Determination. 

    If you are a sponsor with an Andrographis product, please be aware of an upcoming announcement. CMA are examining whether there are possibilities to minimise impacts.

  • 18 Sep 2019 2:55 PM | Anonymous

    In response to issues surrounding the use of 'black salve' in the community, a delegate of the TGA previously made an application to the Advisory Committee of Medicine Scheduling to make Sanguinaria canadensis, or blood root, a Schedule 10 substance when containing 0.01% or more of sanguinarine. S10 are substances of such danger to health as to warrant prohibition of sale, supply and use.

    Following the initial round of consultation, the TGA have made an interim decision (subject to final round of consultation) to confirm this scheduling approach.

    This decision is expected to:

    • Not affect medicines currently listed on the ARTG, including other herbs with sanguinarine as a component such as Greater Celandine (Chelidonium majus), or suitably dilute homoeopathic listings of S. canadensis.
    • Make ineligible any and all supply of black salve or similar topical preparations or any preparations of blood root with more than 0.01% sanguinarine in Australia.
    • It may affect some practitioners who use blood root as a tincture for oral use.
    For further details please see the technical alert here.
  • 17 Sep 2019 3:05 PM | Anonymous

    The TGA have launched an online TBS application form for applying for the evaluation of a new substance, including the ability to upload supporting documentation online, and making the required declarations to submit the application. It also includes the ability to request the two year exclusivity period.

    The online form is accompanied by a new application user guide describing all steps of submitting the online application for a new substance.

    We recommend saving as you go where possible, as the portal is known to occasionally "time out", which can cause loss of any unsaved information on the application page you are in.

    Please advise us if there are any process issues arising with the use of the new form or user guide.


  • 13 Sep 2019 3:07 PM | Anonymous

    We are very pleased to announce that - as foreshadowed in our technical updates and primarily in response to CMA advocacy on this issue - the fee free period for transitioning ARTG listings to permitted indications has formally been extended for 18 months to 6 March 2021 - the final date that medicines can transition before auto-cancellationand this fee-free information update has now been published on the TGA website.

    As noted previously, there was a very short period after 6 September 2019 where the legislation was not yet in effect and if you received an invoice, this will need to be paid and then refunded.

    We would like to thank all our members for your ongoing support and involvement.

    Team CMA.

  • 12 Sep 2019 3:12 PM | Anonymous

    CMA is extremely pleased to provide that the TGA's Scheduling Committee and Delegate have accepted our application to downschedule herbs containing arbutin for oral use, and made the "interim decision" to make them available to practitioners, industry and the public again at the proposed limit. This includes herbs such as Bearberry and Damiana.

    We particularly would like to thank our CMA members and our collaboration with the NHAA who made significant contributions to this effort.

    The "interim decision" is open now for public TGA consultation, for which we seek your support to ensure the decision is made final. Full details are included in today's member alert.
  • 11 Sep 2019 2:53 PM | Anonymous

    An updated Advertising Approval Application form has been released, which includes some minor changes, including reflecting the updated complaints handling process.

    The TGA have requested that applicants use the updated form, available here:

    https://www.tga.gov.au/form/application-advertising-approval
  • 11 Sep 2019 2:23 PM | Anonymous

    The purpose of this technical alert is to provide some additional clarification and information received in respect of the use of herbal and biological components. This is particularly in relation to the use of documentation where there are necessary differences between the manufacturing documents and the ARTG due to the system limitations of the ARTG.

    The full technical alert is available here.
  • 09 Sep 2019 2:25 PM | Anonymous

    On Friday 6 September 2019, the original "fee-free" period to update existing ARTG listings to permitted indications expired. However, CMA advocacy has resulted in an application for an extension to this period.

    We are expecting a full 18-month extension period to 6 March 2021 for fee-free ARTG listing updates.

    We are aware that the fee has now been turned on, contrary to original advice that the fee would not be turned on, and have spoken to the TGA who have provided the following updated information.

    The legislation has been drafted, however, the Australian Government committee that approves regulations need to approve the final draft. The extended fee-free period will not be in effect until the final approval and legislative change occurs which is expected to be either in mid-September or mid-October (2-6 weeks). They have drafted the fee-free legislation to be backdated to 6 September so there will be no period where a fee is payable.

    While the TGA prefers not to turn on the grouping fee for applications to change to permitted indications in the short-term, they have been advised that they should until the new legislation is in effect.

    This means that in the next 2-6 weeks until the change is made and the fee turned off, sponsors can choose to:

    1. Pay the fee when changing to permitted indications, and receive a refund* when the legislation is changed and backdated to 6 September.

    *It's expected that the TGA will only refund applications that currently pass fee-free arrangements, that don't include other changes that trigger a 'new' or 'grouping' application such as changing a medicine name.

    OR

    2. Wait until the TGA remove the fee, when the extended fee-free period is legislated in mid-September or October.
  • 06 Sep 2019 8:38 AM | Anonymous

    CMA has been in ongoing discussions with the TGA on how the TGO 92 labelling order - which is due for final implementation in September 2020 - may be unintentionally causing negative and costly impacts upon brand logos, including locally or internationally registered trademarks, for complementary medicine sponsors.

    We are very pleased to announce that through CMA advocacy, including direct CMA member involvement, the TGA have agreed to offer industry a specialised application process that is intended to provide relief to sponsors whose pre-existing brand logos or trademarks continue to be adversely affected. This specialised application process is being designed to be practical to achieve, and low in cost. It will help sponsors during the next few years, which allows the TGA additional time to examine more permanent options for additional branding flexibility for sponsors. Both the short term and long term processes will continue to have some conditions to ensure that the guiding principles of the TGO 92 – to have improved clarity of labels and medicine names for consumers – continue to be met.

    Members should read the CMA technical alert here, if:-

    • You have a brand name on your ARTG Certificate(s) of Listing and you think your brand logo might be affected by the TGO 92 requirements to have a continuous, uninterrupted, unbroken medicine name as part of Section 9(2) of the Order - this may include small graphics or taglines as part of your brand logo; and you would like to know more about the upcoming process; or
    • Your brand name(s) are not included on the ARTG Certificates of Listings.

    Please note this application process is not yet a public announcement by the TGA. They are working quickly to make these arrangements to help the complementary medicines industry on this branding issue. If you have any questions or comments, please contact us directly (Lucy.Lang@cmaustralia.org.au) rather than the TGA, until more information is published on their website.

    Thanks for your ongoing support.

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