• PO Box 450 Mawson ACT, 2607 Australia

  • 02 6260 4022

Technical Alerts

Technical Alerts

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

  • 28 Oct 2020 4:07 PM | Anonymous member (Administrator)

    The Competition and Consumer Amendment (Australian Consumer Law - Country of Origin Representations) Bill 2020 (the Bill)was debated and passed  the House of Representatives on the 27th October 2020.

    The purpose of the Bill is to amend the Competition and Consumer Act 2010 (the CCA) to widen the definition of what constitutes the ‘substantial transformation’ of goods for the purposes of ‘safe harbour’ provisions relating to country of origin representations - such as ‘made in Australia’ claims.

    The amendment lays the foundation for Australian made complementary medicines to have robust access to a safe harbour Australian origin claim and to the 'Australian Made, Australian Grown' logo. This bill marks the next step towards implementing the government's commitment to establish strong country of origin labelling laws for Australian made complementary medicines.

    For more information on the progression of Country of Origin Labelling (CoOL), please see today's member alert.

  • 28 Oct 2020 1:35 PM | Anonymous member (Administrator)

    Following a plan made by the Australia and New Zealand Ministerial Forum on Food Regulation in November 2019, a review of the food regulatory system including the Food Standards Australia New Zealand Act 1991 is occurring to ensure it remains strong, robust and agile into the future.

    Stakeholders are strongly encouraged to respond to the consultation which is by online survey, and asks key questions about the regulation of foods, including items of key interest to you, including issues regarding the food-medicine interface and the possibility of regular, more holistic reviews of food standards. For more information please see today’s technical alert.

    Responses to the consultation can be done via an online survey until 16 November 2020. 

    It is not necessary to complete the survey in one sitting. You can save your answers and come back later.

  • 23 Oct 2020 2:45 PM | Anonymous member (Administrator)

    The TGA have recently issued a safety advisory for listed medicines containing herbal ingredients from the Artemisia species after becoming aware of studies that indicate certain Artemisia species may pose a risk during pregnancy.

    Though the TGA have stated that no adverse event reports related to the use of listed medicines containing Artemisia species during pregnancy have been received, an investigation into the level of risk associated with different Artemisia species is being conducted.

    For more information about the safety advisory for Artemisia species, including next steps, likely outcomes, and sponsor obligations, please see today's technical alert.

  • 21 Oct 2020 4:15 PM | Anonymous member (Administrator)

    The TGA have recently issued a safety advisory for 'very rare' reactions to Valeriana officinalis (Valerian) following 15 reports of liver injury since 1983. Most cases of reported liver damage resolved after the use of Valerian was discontinued. The current alert and investigation was triggered by an adverse event in 2019.

    For more information about the safety advisory for Valerian, including next steps, likely outcomes, and sponsor obligations, please see today's technical alert.

  • 20 Oct 2020 11:36 AM | Anonymous member (Administrator)

    An important reminder that the transition period for permissible indications ends on 5 March 2021. There are more than 2,000 products, or >20% of listings remaining to be transitioned. 

    Please read this technical alert for more information about the end of the transition period and implications for sponsors and products.

    Critical key points to understand in relation to the transition are that:

    - The last day that sponsors will have to submit their application to re-list their medicine with permitted indications is 5 March 2021.

    - Changes to indications only, remain free until 5 March 2021 due to the 18 month extension to the ‘fee free’ period previously supplied.

    - Any products that do not have updated records by this date will be cancelled from the ARTG and sponsors will no longer be able to supply these medicines.

    - An extension to the date cannot occur in the way that occurred for TGO 92, as the date is included in the Therapeutic Goods Act and there are not the same approval mechanisms in place to be able to extend the applicable date on an individual basis.

    - There will not be any letters proposing to cancel the listing issued prior to the cancellation.

    - Any cancellations that occur are not associated with Section 60 appeal rights.

    - If sponsors do not have evidence of submitting their application to transition to permitted indications on or before 5 March 2021, then the medicine is likely to be captured in the automatic cancellation process

    - Products that are automatically cancelled on 6 march 2021 that sponsors desire to retain would therefore need to be re-listed as new products.

  • 14 Oct 2020 1:46 PM | Anonymous member (Administrator)

    The TGA have published a reminder for advertisers of their responsibility to ensure advertising complies with the legislative requirements specified in the Therapeutic Goods act (the Act). 

    The reminder refers to the TGA advertising guidance, in addition to providing a new Advertising compliance checklist for consumer advertising, which is intended to be used in conjunction with the Act, the Therapeutic advertising Code (the Code) and published guidance.

    Please click here for more important information in relation to advertising considerations, and to access a summary list of advertising resources.

  • 29 Sep 2020 11:39 AM | Anonymous member (Administrator)

    Following the publication of an interim decision on 10 June 2020, and invitation for further comment on substances referred to the March ACMS/ACCS meetings, the Delegate of the Secretary has made a final decision to vary the interim decision and amend the current Poisons Standard in relation to melatonin. A Notice of final decision to amend the current Poisons Standard has been published on the TGA website. The decision will take effect on 1 June 2021.

    Today's technical alert includes the scheduling decision and further information on the amendments.

  • 28 Sep 2020 11:34 AM | Anonymous member (Administrator)

    The TGA have recently issued a safety advisory for Manasmithra Vatika (Manasanitram Pills), following a report of the presence of lead in the Ayurvedic product.

    For more information about the safety advisory, please see today's technical alert.

  • 25 Sep 2020 3:22 PM | Anonymous member (Administrator)

    Today's technical alert contains important information and considerations for industry members in relation to the TGA targeted compliance reviews of Listed medicines considered at risk of containing safrole, including Camphor oil, Cinnamomum camphora, Mace, Myristica fragrans, Nutmeg, Ocotea odorifera, Rosemary oil and Sassafras albidum.

  • 24 Sep 2020 12:09 PM | Anonymous member (Administrator)

    The Sports Supplement decision has been released. Below is an overview summary breakdown of the effects of the decision. Please read today's full member alert for more information about the decision and RIS for Sponsors and Manufacturers. 

    Essential Summary breakdown of effected products:

    "Therapeutic Goods" from 30 November 2023

    TABLETS, CAPSULES or PILLS for oral administration which are (expressly or implicitly) represented* for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity.

    "Therapeutic Goods" from commencement (30 November 2020):

    ANY PRODUCT for oral administration which is (expressly or implicitly) represented for the improvement or maintenance of physical or mental performance in sport, exercise or recreational activity

    and  which contain (or are represented expressly or implicitly to contain) substances that are

    Scheduled substances in the Poisons Standard, or

    the World Anti-Doping Code International Standard Prohibited List (January 2020), or

    a relevant substance (a) dendrobium (Dendrobium nobile); or (b) methylliberine; or

    a substance with equivalent pharmacological action to any of the above.

    *(includes: gaining muscle; increasing mental focus; increasing metabolism; increasing stamina; increasing testosterone levels; reducing oestrogen levels or otherwise modifying hormone levels; losing weight or fat; preparing for workout; recovering from workout).

Copyright © 2019 Complementary Medicines Australia. All rights reserved.

Powered by Wild Apricot Membership Software