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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.

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  • 06 Feb 2023 8:55 AM | Anonymous member (Administrator)

    The TGA has published a Notice of Interim Decisions in relation to green tea extract and melatonin. The consultation on these interim decisions is open now, closing Friday 3 March 2023.

    The Delegate of the Secretary has made the following interim decisions:

    - not to amend the Poisons Standard in relation to green tea extract; this means that if the interim decisions is confirmed by the Delegate through this consultation in the final decision (due in several months time), there will be no change, and GTE will remain unscheduled; and

    - to amend the Poisons Standard in relation to melatonin; to amend the Schedule 3 entry for melatonin to allow divided preparations containing 5 mg or less of melatonin, in packs of no more than 10 dosage units, for adults aged 18 and over to be prescribed by a pharmacist for the treatment of jetlag. This decision is to be implemented on 1 June 2023

    Please read today’s full tech alert for more information on the Delegates reasons for these decisions and CMA's response to the proposal. 

  • 01 Feb 2023 12:04 PM | Anonymous member (Administrator)

    The TGA has published an updated web page on Guidance on using evaluation reports from Comparable Overseas Bodies (COB). The changes to this guidance affect eligible:

    - New substance (or changed substance) applications for the Permissible Ingredients Determination

    - AUST L(A) applications

    - AUST R complementary medicine applications.

    Today’s full alert includes a summary of all key changes to the guidance as well as a comparison table of the 2022 list and the newly published 2023 list of COBs which outlines any changes or additions.

    New COB Checklists are also published to accompany the updated guidance.

  • 01 Feb 2023 11:55 AM | Anonymous member (Administrator)

    The TGA has published a new document on their website outlining the Mandatory Requirements to vary the Permissible Ingredients Determination. The publication of the document coincides with the publication of the new Therapeutic Goods (Permissible Ingredients - Information that Must Accompany Application for Variation) Determination 2023 on the Federal Register of Legislation (FRL), commencing 1 February 2023.

    This means from today, 1 February 2023, there will be an updated process for making applications for a new (or changed) substance in the Permissible Ingredients Determinationincluding mandatory dossier requirements and data requirements (or justifications for not holding the data) in order to pass the preliminary assessment phase and proceed to the evaluation phase. The changes are an outcome of MMDR changes made to the Therapeutic Goods Act in 2018, and aim to standardise and improve efficiency of the application process. Existing applications will not be affected by the changes.

    Compositional Guideline Templates: Four new templates are provided for specific types of substances.

    NEW Guidance for Microorganisms (Probiotics and Postbiotics)

    Additional guidance on the pre-market assessment of characterising microorganisms that are proposed to be used in either Listed medicines or Registered medicines that are to be used as probiotics and postbiotics. It is to be used in conjunction with the Mandatory requirements for an effective application to vary the Permissible Ingredients Determination (new substance application), or Mandatory requirements for an effective registered complementary medicine application.

    The scope of the guidance covers microorganisms are whole and intact cells of bacteria and fungi (including yeasts) that are live or non-viable, but not other kinds of postbiotics, spores, etc.

    Please read today's full alert for more information, background and how to contact CMA if challenges are encountered or changes needed. 

  • 31 Jan 2023 11:29 AM | Anonymous member (Administrator)

    The TGA has published a consultation seeking feedback on proposed improvements to the product recalls process, which have been based on previous stakeholder feedback. The consultation, closing Monday 13 March, proposes significant changes to the recalls process. the attached alert outlines some potential benefits or concerns from an industry perspective.

    Recalls are relevant to many stakeholders therefore the following stakeholders may wish to respond to some or all of the consultation questions:

    - Sponsors

    - Manufacturers

    - Retailers

    - Practitioners, Consumers 

  • 23 Jan 2023 9:03 AM | Anonymous member (Administrator)

    Transition Reminder

    Members are reminded that the end of the transition period for certain ingredient changes is approaching on 28 February 2023.

    Some changes relate to pregnancy warnings, or allergen warnings, which are often subject to retail or consumer level recalls if the required statements are not included.

    Vitamin B6

    - maximum daily dose change from 200mg to 100 mg (adults);

    - maximum daily dose change for children (depending on age group)

    - warning statements on labels for products containing > 10 mg pyridoxine per MRDD.

    Artemisinin containing herbs

    - End of transition period to include a pregnancy warning for certain existing artemisinin containing ingredients.

    Mollusc derived ingredients

    - Updated allergen warning

    These ingredients were subject to changes following the outcomes of the 2021-22 Permissible Ingredients Consultation. Please see CMA's 27 September 2022 tech alert, the TGA Final Decisions Document and the TGA Oct 2022 publication on Vitamin B6 for more information. 

    Please note: Due to recent changes in the Advertising Code ‘health warnings’, members should also ensure, as a priority, that relevant advertisements (e.g. where an advertisement facilitates directly the purchase or other supply of a medicine; and the medicine is not available for physical inspection by a consumer prior to purchase or other supply)  have the required warnings.

  • 20 Jan 2023 3:31 PM | Anonymous member (Administrator)

    A notice of final decisions has been published on the TGA website in relation to dichloromethane (also known as methylene chloride).

    CMA is pleased to inform members that the Delegate has decided to vary the Interim Decisions to clarify the entry for dichloromethane in the Poisons Standard by including a new exemption for human therapeutic preparations in the Schedule 5 entry.

    In our response to the original proposal and interim decision, CMA continued to seek alignment of the entry for dichloromethane in the Poisons Standard with the Determination, TGO 101 and ICH guideline Q3C (R8) for residual solvents, to ensure consistency of requirements across the regulatory framework.

    Therefore, this final decision not only prevents the initially proposed total S10 ban on dichloromethane, it also resolves the issue of the Poisons Standard to-date not being aligned with other regulatory legislation. It prevents the unnecessary removal of complementary medicines from supply and assures the ongoing safe supply of the affected nutrient fractions and herbal extracts. It allows listed medicines with the affected nutrients and extracts to remain in legal supply, provided they remain compliant with the required cut-off limits in other regulatory requirements as described further in this alert.

  • 18 Jan 2023 8:41 AM | Anonymous member (Administrator)

    The TGA has published an updated web page on revised guidance for listed medicines to include two new learning modules developed by the TGA to assist sponsors of listed medicines to understand how to use the Evidence Guidelines. These modules aim to supplement the information in the Evidence Guidelines. Click here to read more.

  • 13 Jan 2023 11:20 AM | Anonymous member (Administrator)

    Yesterday we sent an alert about registering for the GMP Forum on Tuesday 21 March 2023, at the ICC Darling Harbour.

    Important note - workshop places are limited to the first 60 people who apply to attend.

    Particularly for sessions 3 and 4, the workshops may be more relevant for CM sponsors, so if these workshops are your preference, please register early to ensure you secure a workshop place.

    For some sessions, you have the option of attending one workshop (limited to 60), or two consecutive talks – to select the correct session choices please check the program here before registering.

    When finalising payment, it asks for the Client ID numbers – members are reminded to enter the code ‘CO-9001’ instead of their TGA client ID number (which do not work for this process), and to select the 19 option (GMP Forum 2023 Registration), per the TGA example on the website.

    For all other registration, payment and event enquiries, please contact the TGA directly:

    GMP Forum Team

    1800 020 653

  • 12 Jan 2023 12:30 PM | Anonymous member (Administrator)

    Please find below a list of legislative updates for 2023. In particular, complementary medicine sponsors should note that for medicines listed form 24 December 2022, standard conditions of listing are no longer applied through ELF at the time of Listing or by a Notice from the TGA, but applied through a NEW Determination.

    - New Conditions of Listing Determination will apply to listed medicines included on the ARTG from 24 December 2022, replacing the previous application of conditions by a Notice (Letter) from the TGA. However, the content of the conditions remain unchanged. 

    -New TGO Standard for Medicines using Serialisation or GTIN data matrix codes

    - Updated Advertsising Code Compilation to include the most recent Covid-19 vaccine advertising permission.

    - Updated Poisons Standard from 2023– changed format, definitions, substantive provisions. The TGA state there are no change to Scheduling of substances. CMA will be monitoring if there are impacts on herbs and asks members to note the below information (page 5 of this alert) regarding complex preparations that have more than one substance restricted by scheduling.

    - Updated Therapeutic goods Regulations – to reflect changes to devices including nanomaterials and IVDs.

    More information and details are available via this tech alert.

  • 12 Jan 2023 9:27 AM | Anonymous member (Administrator)

    Registrations are open for the Good Manufacturing Practice (GMP) Forum, to be held in Sydney on 21 March 2023 at the International Convention Centre in Darling Harbour from 8.30am to 6.30pm.

    The forum is an in-person only event and include a variety of plenary sessions, break-out sessions, workshops, exhibition stations and a networking event. The workshop program will be limited to 60 people per session so be sure to register early to secure your place.

    A ticket fee of $350 per person applies for early-bird registration - until Sunday, 19 February.

    A fee of $450 per person will apply from Monday 20 February (unless sold out earlier).

    Click here to Register and to access the Forum program.

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