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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.

  • 29 Sep 2021 3:47 PM | Anonymous member (Administrator)

    The TGA have published new guidance on the Data Protection scheme for assessed listed medicines, which was introduced into the Therapeutic Goods Act 1989 in February 2021. The guidance outlines in detail the operation of the Scheme and requirements and expectations for the sector to utilise the Scheme.

    Please read today's full Member Alert for more information and details, including on clinical trial and eligibility requirements of the Scheme. 

  • 28 Sep 2021 8:47 AM | Anonymous member (Administrator)

    The TGA have published new guidance on exporting medicines form Australia. This is a NEW and comprehensive guidance document on exporting medicines form Australia and should be reviewed by all sponsors and persons exporting medicines.

    The guidance replaces all previous guidance about the export of medicines from Australia.

    The guidance covers topics including:

    - Exporting medicines for commercial supply including listings, exemptions, certificates and importing country expectations, TGA assessment criteria, applications, changes, and a wide range of other regulatory matters

     - Exporting medicinal cannabis

    - Exporting unapproved goods

    - Export certification for medicines - Australia's medicine export certification process, the World Health Organization (WHO) Certification Scheme and Types of export certificates

    - Application process and applications that do not meet requirements, applications put on hold

    - Non-commercial export - Exporting medicines for donation; Exporting for personal use, family or friends

    Please read today’s full technical alert for more information and contact CMA with any concerns about information or processes included in the document. Please also note the TGA are still receiving feedback on this publication in case any changes are required.

  • 20 Sep 2021 8:45 AM | Anonymous member (Administrator)

    The TGA have published information on the their website and the Department of Health Consultation Hub in relation to the consultation on proposed changes to the Therapeutic Good Advertising Code, which occurred from May 2021 to June 2021.

    As a result of the feedback received, the TGA have decided to re-write the Code using a ‘simplified structure and plainer language’ and have stated that they will ensure that the guidance on the Code is more accessible and user-friendly. It is anticipated that new Code will be published by the end of 2021.

    Please read today’s technical alert for more information

  • 13 Sep 2021 3:16 PM | Anonymous member (Administrator)

    Today's technical alert includes information on the final decision to amend (or not amend) the Poisons Standard in relation to matters referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (Joint ACMS-ACCS #27, March 2021). In particular, information in relation to the outcomes on:

     -Hemp Seed Oil; and

     - Processed Aconitum carmichaelii: A scheduling case as it relates to CM/TCM practitioners.

  • 10 Sep 2021 10:15 AM | Anonymous member (Administrator)

    The TGA have provided an extension to the closing date for the Permissible Ingredients Determination low-negligible risk consultation. The consultation closing date is now 29 September 2021. Please note, this updated date is reflected in the Consultation Hub, but will not be reflected on the TGA web page. The date on the Consultation Hub is the correct date. 

    The changes proposed in the consultation changes relate to:

     - Peripheral neuropathy associated with lower dose vitamin B6 - a proposed reduction of maximum daily intake from 200mg/day to 50mg/day; and extension of a warning statement for products providing between 10-50mg of equivalent pyridoxine.

    - Artemisinin and pregnancy risk - proposed new label requirements for Artemisinin containing products, which may also affect products that have DAVANA OIL in a flavour or fragrance. These changes are proposed as part of the ongoing review of Artemisinin containing medicines and pregnancy risk by the TGA. If you sell DAVAN OIL in any format or in a fragrance or flavour , please contact

    - Allergen Statement for mollusc derived ingredients - proposal for ingredients on the Permissible Ingredients Determination  that are derived from a marine mollusc (substances derived from squid, oyster, green lipped mussel or homeopathic sepia) be updated to include the warning statement :Contains mollusc" or "Contains mollusc products", in alignment with FSANZ Plain English Allergen labelling (PEAL) reforms. it differentiates mollusc as an allergen from crustacea and fish allergens. if this change is made to mollusc ingredients in March 2022 as proposed, this statement would replace the existing requirements to include "Derived from seafood" from that point forward. Sponsors would have until March 2023 to transition existing  listed products to include the new mollusc warning.

    Mollusc warning note: CMA provisionally supports the change to the  mollusc warning statement and also consider that this particular change is  likely to be inevitable due to the necessary alignment with FSANZ PEAL  best practice allergen reforms. As there is only a 12 months transition  (March 2022 to March 2023), CMA has sought clarification from the TGA  as to whether products who wish to transition between now and March  2022 (before the Determination is updated) may choose to include both  the statements “Derived from Seafood” as currently required AND  “Contains mollusc” as proposed to be required from March 2022 - the  TGA have responded that they do not hold a compliance concern about  the use of both statements on the label.

    This provides an avenue for sponsors who may wish to transition  products early if they are due for their next label run between now and  when a final decision is made and implemented into the 26BB  Determination in March 2022.

  • 10 Sep 2021 10:10 AM | Anonymous member (Administrator)

    Today's technical alert includes:

     - An update on Codex/international discussions on titanium dioxide; and

     - TGA Scheduling Consultation: Proposed amendments to the Poisons Standard - Cannabis and tetrahydrocannabinols for veterinary use.

  • 10 Sep 2021 10:02 AM | Anonymous member (Administrator)

    Please be aware that currently, neither the Therapeutic goods Permissible Ingredients Determination (No. 2) 2021, nor the Therapeutic goods Permissible Ingredients Determination (No. 1) 2021

    Do not exceed the stated dosage except on medical advice. If you have had a baby with a neural tube defect/spina/bifida, seek specific medical advice (or words to that effect).

    The change occurred in March of this year, and was not subject to public or targeted consultation before it was made. Therefore listed medicine sponsors making new or updated products since March may not have been aware of the change or to the ongoing need to include the statement on products which contain the following permitted indication:

    Help to prevent neural tube defects such as spina bifida and/or anencephaly (for medicines where the recommended daily dose of the medicine provides a minimum of 400 micrograms of folic acid).

    We recommend that if you have listed (or re-listed) a pregnancy or folic acid product in 2021, that you check the label for the inclusion of the NEUR statement, and if currently listing products, to include the statement until such time as the TGA completes a review of the change that occurred, and conduct any updates to the above documents as needed.

    Within this context of review, clarification is also being sought on required applicability of the VIT label statement as it relates to this particular indication in respect of the 2020 Pregnancy Care Guidelines and we will provide any relevant update as available.

    For any questions or product related issues, please contact for support.

  • 26 Aug 2021 12:27 PM | Anonymous member (Administrator)

    This is a technical alert to highlight and clarify that the laxative warnings for products containing magnesium amino acid chelate are no longer required for this ingredient. The removal of these requirements is correctly reflected recently published an currently in force Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2021 and its explanatory statement (Note that the laxative warnings still apply to other magnesium salts that are inorganic - as always please check the in-force Determination for each ingredient in your medicine to confirm requirements before proceeding with product decisions).

    On 1 March 2021, the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2021 commenced and the ingredient magnesium amino acid chelate (not an inorganic salt) incorrectly included new requirements for inorganic magnesium salts that were determined as a result of the outcome to the 2020-2021 consultation. This TGA consultations outcomes webpage will be updated shortly to reflect that the requirements will not apply to magnesium amino acid chelate.

    On 12 August the TGA advised CMA of changes to the Determination through publication of version N.2 of 2021. On 13 august, CMA conveyed this information to members through a technical alert, including links to the newly published Determination which shows that the requirements do not apply. However, this technical alert also contained a table taken from the a TGA table which incorrectly displayed in the new requirements column that the requirements still applied to the ingredient - therefore, our table in this technical alert has also been updated to correctly reflect the removal of these requirements at the provided links (Word and PDF). 

    The TGA is also sending an email to sponsors whom have magnesium amino acid chelate as an ingredient in an ARTG listing, to clarify the removal of the laxative warnings. To summarise, the laxative warning statements no longer apply to this ingredient, the Permissible Ingredient Determination has been correctly updated, the TGA consultation outcomes page will be updated shortly, the CMA table in the document has also been updated, and if you have this ingredient in a medicine you should also expect a clarifying email from the TGA in the near future.

  • 24 Aug 2021 10:30 AM | Anonymous member (Administrator)

    Please see below for updates on several separate issues:

    1. Titanium dioxide

    For evolving information on titanium dioxide, please click here. A reminder that the FSANZ consultation is closing on 17 Sep 2021 and that they are seeking specific data for a safety assessment that may be sent directly to FSANZ. If you prefer to send unidentified or redacted company data through submission by CMA, this information may be sent to us by 16 Sep 2021 at FSANZ has nominated the below information is eligible to be submitted as part of their safety assessment:

    - Physico-chemical characteristics and composition/specification documents of titanium dioxide as currently used food additive. Characteristics include particle size, size distribution and morphology, any size-dependant properties. Nanoparticulate material should be quantified and the composition and specifications should be provided.

    - Unpublishes genotoxicity studies (in vitro or in vivo) with titanium dioxide. 

     - Other unpublished studies relevant to a safety assessment.

    2. Sponsors holding Section 17 consents regarding TGO 92 Section 9(2)

    The TGA have provided a commitment to give an extension for all existing s14/14A consents that relate to section 9(2) of the TGO 92, without the need for another formal s14/14A consent application from the sponsor. However, an extension will be granted only if the consent is still required and once confirmation of the need is received from affected sponsors. Therefore, the TGA is contacting sponsors with current S14/14A consents (in relation to section 9(2) of TGO 92) and requesting confirmation that an extension is required. A new consent will then be given until 1 September 2022

  • 19 Aug 2021 1:37 PM | Anonymous member (Administrator)

    TGA Stakeholder Survey

    The TGA is inviting consumers, health professionals, industry and other stakeholders to share their views in their annual stakeholder survey.

    The feedback received is proposed to be used to help report on the TGA’s key performance indicators and to make ongoing improvements to stakeholder engagement. The survey takes around 10-15 minutes to complete and will remain open until Friday 27 August 2021. Please click here to access the survey.

    TGA Presentations: Good manufacturing Practice (GMP) Forum

    The TGA GMP Forum presentations, held online on 12- 14 May 2021, are now publicly available on the TGA website. Please click here to access the the presentations.

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