Log in
  • 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.

  • 22 Sep 2023 3:40 PM | Anonymous member (Administrator)

    CMA are pleased to share with our members some of the work that has been keeping us busy over recent months. CMA have submitted responses to a variety of consultations affecting various aspects of the complementary medicines sector, a summary of which is outlined below.

    These submissions reflect our shared and ongoing commitment to the success of the sector. Our collective efforts as an industry continue to demonstrate dedication and commitment in advocating for positive change. We thank our members for their ongoing engagement. 

    Please ensure you are logged in to the CMA website to view CMA’s submissions.

    Turmeric, Curcumin, Green Tea and other ingredients (TGA)

    - CMA submission to the TGA consultation: Proposed changes to the Permissible Ingredients Determination - low negligible risk: Curcuma species/curcumin; Green Tea; Soy-phosphatidylserine enriched ingredients; Kakadu plum - 14 September 2023. Link

    Probiotics Regulations (TGA)

    - CMA Submission to the TGA consultation: Guidelines for the Quality of Listed Probiotic Medicines - 8 September 2023.Link.

    Sustainability & Environmental Product Claims (ACCC)

    - CMA Submission to the ACCC consultation on Environmental and Sustainability Guidance - 15 September 2023. Link.

    National Health and Climate Strategy (Dept. Health)

    - CMA Submission to the Department of Health and Aged Care National Health and Climate Strategy - July 2023. Link.

    Formulated supplementary sports foods (FSANZ)

    - CMA Submission to the FSANZ review of Nutrition and Health Claims for formulated supplementary sports foods. Link.

    Labelling of Complementary Medicines(TGA - early, non public consultation)

    - CMA Submission to the TGA Targeted TGO 92 consultation: Australian medicine labelling rules: Targeted consultation on priorities for future improvement to TGO 91 and TGO 92 requirements. Link.

    Labelling of Complementary Medicines that are large dosage forms (TGA early, non public consultation)

    - CMA Submission to the TGA Targeted TGO 92 consultation*: Australian medicine labelling rules: Large solid oral dosage forms intended to be swallowed whole* Link.

    *Please note, CMA’s response to the TGA Targeted consultation on TGO 92 will not be published on the TGA website, or made publicly CMA. This is strictly for member information purposes only and may not be re-published or reproduced.

  • 21 Sep 2023 10:02 AM | Anonymous member (Administrator)

    The TGA has published their 2022-23 Advertising Compliance Report.

    This report covers the 2022-23 financial year and includes information on the TGA advertising and supply compliance priorities 2022-23 (outlined in CMA’s 26 July 2022 tech alert), which include matters relating to:

    - Unapproved performance and image enhancing products and sport supplements;

    - Unapproved therapeutic goods associated with COVID-19;

    - Advertising of therapeutic goods used in the cosmetic and beauty industry; and

    - Advertising of unapproved goods on digital platforms.

    The report details numbers of alleged advertising contraventions, TGA compliance assessment outcomes and actions, and the TGA’s approach to compliance education and enforcement.


    - TGA web page: Therapeutic Goods Advertising and Compliance Education Plan 2023

    - TGA web page: Therapeutic Goods Advertising Compliance Education Strategy 2021 

    Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021

    - TGA web page: How we manage Advertising Compliance

    - CMA 26 July 2022 tech alert: TGA Compliance Priorities 2022-23: Import, Advertising and Supply including unapproved goods, e-commerce supply of unapproved goods; COVID-19 or serious diseases; sports supplements, medicinal cannabis 

  • 18 Aug 2023 12:25 PM | Anonymous member (Administrator)

    The Management of declarations of substances of concern(or groups of substances, including allergens) on labels, as it relates to manufacturing processes, was raised by the TGA at the TGA GMP Forum held on 21 March 2023.

    Due to industry concerns about the application of this information, CMA investigated further with the TGA and alerted members via a tech alert update on 31 March.

    CMA are now pleased to provide further clarification to members on this issue, including outcomes of discussions, a link to the updated GMP Forum presentation, and additional background and context.

    Please read today's full tech alert for more details.

  • 10 Aug 2023 2:03 PM | Anonymous member (Administrator)

    The TGA have announced in an email to stakeholders that they are holding a targeted consultation seeking feedback, closing 7 September 2023, on priorities for future improvement to the Therapeutic Goods Order No. 92 Standard for labels of non-prescription medicines (TGO 92).

    A ‘targeted consultation’ is a consultation that is not conducted publicly, but is only conducted with specific stakeholders known to the TGA, such as industry association bodies like CMA, as well as sponsors.

    The purpose of this consultation is to seek input before the TGA develop proposals to be included in future public consultation.

    The targeted consultation paper outlines some potential TGA identified areas for improvement TGO 92. It also includes targeted consultation on labelling matters regarding large solid oral dosage forms (choking hazard issue) before a public consultation follows.

    Please read today’s full tech alert for more information and details about the consultation, including background, highlighted questions relevant to the CM industry, and an overview of current CMA-identified opportunities for labelling improvement.

  • 03 Aug 2023 2:34 PM | Anonymous member (Administrator)

    The TGA have published the annual public consultation for proposed ingredient changes to the Therapeutic Goods (Permissible Ingredients) Determination (‘the Determination’) for issues considered lower to negligible risk, open from today, Thursday 3 August 2023 to 23:59 AEST Thursday 14 September 2023.

    Ingredients under review include:

    1. Curcuma species and curcumin and the risk of liver injury
    2. Green Tea (Extract) and the risk of liver injury
    3. Benzophenone carcinogenicity concerns, proposed to be restricted to topical use at a maximum of 26ppm
    4. Clarification of the requirements for soy phosphatidylserine enriched ingredients, including proposed 300mg MRDD
    5. Clarification of the requirements for Terminalia ferdinaniana (Kakadu Plum)

    Please read today’s full alert for more information, background and details.

  • 02 Aug 2023 10:46 AM | Anonymous member (Administrator)

    The TGA has made changes to  pharmacovigilance expectations for sponsors following consultation on Proposed changes to Pharmacovigilance responsibilities of medicine sponsors: Australian recommendations and requirements.

    There will be a 6-month implementation period, beginning Tuesday 1 August 2023, and concluding on Wednesday 31 January 2024during which adoption of the changes included in the updated guidelines  are strongly encouraged, but not mandatory and will not be inspected against. Sponsors are encouraged to review the new guidance closely to ensure pharmacovigilance systems become aligned with the new system.

    This technical alert provides more information for members, including a summary of consultation outcomes, a comparison between the previous and new Pharmacovigilance guidance, and details of a series of upcoming TGA webinars, which will outline and explain the changes to the Pharmacovigilance Guidelines.

  • 31 Jul 2023 3:47 PM | Anonymous member (Administrator)

    The TGA implemented the Good Clinical Practice (GCP) Inspection Program in 2022 and have recently published the first report on the program covering July -December 2022.

    The TGA are now conducting a webinar on Insights from the TGA Good Clinical Practice (GCP) Inspection Program and will be running the same webinar twice to increase the ability for stakeholders to attend.

    In this webinar, TGA presenters Tahli Fenner and Anastasia Makshakova will provide:

    - an overview of the GCP inspection program

    - insights from the first year of the program.

    This information may be of interest to Research and academic institutions conducting clinical trials and Sponsors and other members sponsoring or involved in clinical trials, or considering entering the AUST LA pathway.

    Session 1

    When: Monday 7 August 2023

    Where: Online

    Time: 4-5 pm AEST 

    Register HERE

    Session 2

    When: Wednesday 9 August 2023

    Where: Online

    Time: 12-1pm AEST 

    Register HERE

    More information on the GCP Inspection Program is available on the TGA website.

  • 31 Jul 2023 1:43 PM | Anonymous member (Administrator)

    FSANZ has announced a consultation on Standard 2.9.4 – Formulated Supplementary Sports Foods (FSSF) of the Australia New Zealand Food Standards Code, closing Monday 4 September 2023The consultation scope is on the regulation of nutrition content and health claims for sports foods.

    FSANZ is gathering stakeholder views through this consultation, before developing specific proposed changes to the Standard 2.9.4, which will then be subject to a 1st statutory Call for Submissions (public consultation).

    CMA recommends that it will be most effective for members express their views in the current consultation in order to shape the future development of the Standard. Please click the above link for more information.

    Please read the full alert here

  • 31 Jul 2023 1:24 PM | Anonymous member (Administrator)

    Following the correct TGA recalls process: Examples

    In October 2019 the TGA released a recalls online form through the TGA's eBusiness service (eBS) Portal.

    Due to the pandemic, the TGA still accepted some email notifications on a case-by-case basis until June 2023. However, the TGA now wish all recall actions and notifications to be submitted via the online form. This Technical alert covers information about using the form expected by the TGA under current circumstances. 

    NOTE: Earlier this year the TGA sought submissions from the public on potential changes to how product recalls are taken in Australia. The outcomes of this consultation are yet to be published and implemented. Published submissions are available here. The Government will consider all submissions prior to making decisions to the URPTG. The online form will remain in place, however changes to the form may be made in the future. In the interim, existing processes and the online form must be followed.

    Sponsors are asked to be aware of the following in regards to the online form:  

    - As of 1 July 2023, the TGA expect all recall actions to be via the eBS Portal’s online recall submission form (unless TGA have given an exception for genuinely urgent circumstances).

    - Sponsors who continue to submit actions via email without a sufficient reason will be directed to submit the information via the eBS Portal within 24 hours. If this does not occur, the TGA will process this as a 'Recall Not Following the URPTG' published in the SARA database and notified to State and Territory authorities. 

    - Some submissions being left incomplete or providing inadequate information are resulting in delays. Mandatory fields are expected to have the correct information included in the field (not terms such as ‘see attached document’). All relevant fields should be completed. 

    E.g., the Problem Description field should plainly and succinctly summarise the problem; and the Product Description should include all relevant identifiers, including the product name, ARTG number, any model/batch/lot/code number(s) and expiry date(s) as applicable.

    - Key documents for a recall action i.e. draft customer letter, distribution/customer list and the health risk/hazard assessment, must be included with your submission. If any information is not available at the time of submission, please notify as soon as possible. 

    - Customer lists: There has been some inadequate attention to detail and some significant variations occurring within the same company e.g., suburb information not provided, suburbs and customers incorrectly matched, suburbs and/or customers in the wrong State or Territory, irrelevant details such as customer ABN and account numbers. The correct content and format for customer lists are shown on page 22 of the URPTG and must be submitted in MS Xcel format using the attached template.

    Example documents to assist members:

    Examples of the required information for each field of your online submissions, and how this information will eventually be published in the SARA database:

    2023 Example of filling out a TGA Online Recall Submission Form (PDF)

    Example of an invented customer list, with a range of guidance information included:

    2023 Example of a Customer List with guidance information (XLXS)

    Improvement in the quality of submissions will assist TGA assessing and agreeing to market action in a shorter time.

    In the event of a system issue with the online form, please contact the TBS Helpdesk on 1800 010 624, or by email at

    Other resources:

    TGA Website: Submitting recall information  

    TGA Presentation: New Online Web Form for submitting Recall and Non-Recall actions

    A printable version of this alert is available here.

  • 24 Jul 2023 10:53 AM | Anonymous member (Administrator)

    The TGA has announced a public consultation on the proposed New Guidelines for the Quality of Listed Probiotic Medicines. It applies to quality expectations for finished products that are listed or assessed listed medicines [AUST L or AUST LA].

    The consultation is open from today, 24 July 2023, until Sunday 10 September 2023.As a public consultation, the TGA will receive comments from any person or group. We encourage your feedback to also be submitted to CMA

    - Members are urged to review the proposed guidelines to determine if any aspects cause a concern for your business.

    The stated purpose of the Guidelines is to:

    - help sponsors and manufacturers meet the regulatory requirements to ensure the quality of their probiotic medicine is acceptable under the Therapeutic Goods Act 1989 (the Act); and

    - assist with sponsor and manufacturer compliance by naming and explaining the most relevant applicable legislation related to ensuring the quality of probiotic medicines.

    Please read today's full technical alert for more information, including relevant background, transition information, consultation questions and details on how to respond to the consultation.

Copyright © 2019 Complementary Medicines Australia. All rights reserved.

Powered by Wild Apricot Membership Software