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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.

  • 10 Jun 2020 1:17 PM | Anonymous member (Administrator)

    A new Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2020 (the Determination) has commenced. This instrument is made under section 26BB of the Therapeutic Goods Act 1989 (the Act)and repeals the Therapeutic Goods (Permissible Ingredients) Determination no. 1 of 2020.

    This technical alert includes a summary of all changes to the determination, in addition to a list of changes with a Checklist/Notes field for sponsors to use, as part of a table detailing every change to check against products, including:

    - Each new or changed ingredient

    - The original requirements

    - The new (amended) specific requirements & any applicable concentration percentages

    Please view the full technical alert here for more information.

  • 10 Jun 2020 11:10 AM | Anonymous member (Administrator)

    Today's technical alert includes some important information for members applying for Section 14/14A consents, including those seeking extra time to comply with the requirements of the TGO 92 due to recent business disruptions. 

    Please find today's alert here.

  • 05 Jun 2020 8:47 AM | Anonymous member (Administrator)

    From 1 September the transition period to the TGO 92 ends, meaning from that date, products 'released for supply' by the manufacturer are required to comply with the TGO 92 as the standard for labels od non-prescription medicines.

    In response to requests from CMA and other industry, the TGA are providing a streamlined mechanism whereby sponsors who have been experiencing administrative delays and challenges due to the Covid-19 disruptions, are able to request consent via a form to supply listed medicines with labels that continue to comply with the older TGO 69 labelling order until 6 March 2021. Registered medicines will be given until this time and potentially longer depending upon request and circumstances. The cost of this Section 14/14A application is $480 which will accommodate up to 20 products.

    Please read this technical alert for more information and details on how to apply.

  • 29 May 2020 12:51 PM | Anonymous member (Administrator)

    Cannabiniod update

    In ongoing global recognition of the low risk safety profile of cannabidiol (commonly called 'CBD') and broad spectrum hemp extracts, the Republic of South Africa have gazetted a change to the Schedules of the MEDICINES AND RELATED SUBSTANCES ACT, 1965, to make two cannabis preparations for internal therapeutic use available as 'Category D' complementary medicines that can only make lower level therapeutic claims - the south African equivalent of listed complementary medicines in Australia.

    The change means that two different preparations are now permitted:

    - A low dose cannabidiol (currently in Australia this is the equivalent of a Schedule 4 registered medicine preparation; and proposed by the TGA to be a Schedule 3 Pharmacist Only registered medicines preparation);

    - A cannabis extract with naturally occurring quantities of cannabiniods (other than cannabidiol) in the finished product (currently in Australia this preparation is the equivalent of a Schedule 9 prohibited substance - Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with the approval of Commonwealth and/or State or Territory Health Authorities). 

    Members can view the development and a comparison to current Australian down-scheduling proposals in today's technical alert.

    Advertising Roundup

    The TGA have issued a warning to Sponsors of cold and flu medicines that advertising cannot conflict with current public health campaigns, in particular, the messaging should not promote out-of-home activities such as work/school/other activities with (suppressed) symptoms, which would conflict with Government COVID-19 guidance.

    The Federal Court have fined GSK and Novartis $4.5m for the misleading advertising of two OTC gels for joint pain that had the same active ingredient.

    Members are reminded that the requirement to have pre-approval for advertisements appearing in specified media ends on June 30 2020.

    The TGA have guidance available for advertisers on social media platforms.

  • 27 May 2020 1:54 PM | Anonymous member (Administrator)

    The TGA have recently issued a safety advisory for Andrographis paniculata (Andrographis) following adverse event reports which have associated the use of Andrographis with potential taste disturbances, such as changes to the sense of taste, including the potential for complete loss of taste. For more information about the safety advisory, please see today's technical alert.

  • 27 May 2020 11:25 AM | Anonymous member (Administrator)

    Today's technical alert contains some detail for members on the Data Protection Scheme for Listed (Assessed) complementary medicines, which is before the House of Representatives as part of an amendment Bill to the Therapeutic Goods Act 1989.

    The Scheme provides a critical element of incentivising innovation into new therapeutic indications for ingredients used in listed complementary medicines.

    This technical alert includes:

    -A summary overview of the intended Scheme's purpose, benefits, operation and key functional elements; and

    -Background to the Scheme and a copy of the relevant amendments coupled with legislative explanatory notes.

    Further detailed parameters and context will become available as implementation of the scheme progresses.

  • 25 May 2020 5:18 PM | Anonymous member (Administrator)

    For more information on flexibility on time frames for both the TGO 92 and TGO 10, please see today's technical alert

  • 20 May 2020 12:46 PM | Anonymous member (Administrator)

    The TGA have published a revision to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM), which replaces the previous version (ARGCM V8.0).

    The ARGCM provides guidance for manufacturers, sponsors, healthcare professionals and the general public on the regulation of complementary medicines in Australia.

    Click here for more information regarding the revised ARGCM.

  • 15 May 2020 4:01 PM | Anonymous member (Administrator)

    Today's Member Alert contains new industry updates in relation to:

    - The publication of CMA's position statement on the down-scheduling of Cannabidiol (CBD)

    - AUST L(A) Data protection: the Therapeutic Goods Amendment (2020 Measures No.1)Bill 2020.

    - The upcoming end to the Advertising Pre-approval process.

    Please click here for more details.

  • 08 May 2020 1:42 PM | Anonymous member (Administrator)

    Following the publication of an interim decision on 6 February 2020, and invitation for further comment on substances referred to the November 2019 ACMS/ACCS meetings, a second review of restrictions for caffeine occurred via the Scheduling mechanisms. The Delegate of the Secretary has made a final decision to affirm the interim decision and amend the current Poisons Standard in relation to caffeine. A Notice of final decisions to amend (or not amend) the current Poisons Standard, May 2020, has been published on the TGA website. The decision will take effect on 1 June 2020.

    Today's technical alert includes:

    -The scheduling decision

    -An outline of the relationship of this decision to Listed Medicines and the Permissible Ingredients Determination

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