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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.

  • 23 Jan 2019 1:32 PM | Anonymous

    In response to CMA's efforts, the Department of Industry, Innovation & Science have opened ataskforce investigating the effect of the changes in "Made in Australia" policy to the complementary medicines sector.

    The taskforce has developed a survey specifically seeking commentsfrom Australian businesses directly involved in producing vitamins, minerals or supplements, and/or those selling these products under a private label or brand.

    CMA strongly encourages members to assess business impacts and participate in the survey. More information and links to the survey here.

  • 11 Jan 2019 1:33 PM | Anonymous

    Today's technical alert includes information on the recent update to the GMP Clearance Guidance (v 18.1); Advertising Q&As; Curcuminoids naming update; and SME workshop for Adelaide, here.

  • 18 Dec 2018 1:35 PM | Anonymous

    The TGA has released an important Public Consultation to remake the TGO 78 that will set the manufacturing standards for Tablets, Capsules and Pills for the next foreseeable decade. Traditional Chinese Pills are being incorporated into the new TGO with a 12 month transition.

    Although many requirements remain unchanged, there are some significant changes including:

    A) The ability to choose whether to apply the Australian specific requirements for compliance, or to use an applicable monograph for the specific finished tablet or capsule from the BP, EP, or USP (with additional specific requirements).

    B) Regardless of which standard is chosen, the TGA are proposing that all listed and registered tablets, capsules and pills will have applicable impurity limits, specifically, Arsenic, Lead, Cadmium, Mercury, and residual solvents.

    Submissions close on 8 February and the remade Order will be in place by 31 March 2019.

    More information and details are included here.

  • 27 Nov 2018 3:50 PM | Anonymous

    Please find the latest technical alert here, which includes:

    - CMA Annotated version of the Advertising Code (No. 2) 2018 for member use

    - Other advertising updates, including TGA suggested social media policy and upcoming webinar

    - Food Regulations guidance, "Getting Your Claims Right"

    - NZ Medsafe alert on Artemisia annua products

  • 27 Sep 2018 11:31 AM | Anonymous

    Permissible Ingredients Determination No 3 of 2018, including new exclusive ingredients

    Click here to read more

  • 24 Sep 2018 11:29 AM | Anonymous

    APPROVED - Positive Claimer of Efficacy for TGA-Assessed Complementary Medicines
    Click here to read more

  • 19 Sep 2018 11:28 AM | Anonymous

    NEW Therapeutic Goods Order No. 98 – Microbiological Standards for Medicines 2018; TGA hosting Stakeholder Forum on Faecal Microbiota Transplantation

    Click here to read more

  • 28 Aug 2018 11:49 AM | Anonymous

    The TGA have announced changes to herbal component name regulation and a list of frequently asked questions about the changes. More information here

  • 20 Aug 2018 12:44 PM | Anonymous
    An updated version of the Guidelines for Assessed Listed Medicines have now been released. Presentations for the Inaugural GMP Forum have also been published. For details of the changes to the guidelines and links to the GMP presentations, please click here.
  • 13 Aug 2018 3:07 PM | Anonymous

    The template for compositional guidelines has been updated to include version control. More information here.

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