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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.

  • 01 Jul 2021 9:01 AM | Anonymous member (Administrator)

    The Department of Industry, Science, Energy and Resources have announced available funding for eligible businesses under the Manufacturing Collaboration Stream of the Modern Manufacturing Initiative.

    Applications are accepted from 11 August 2021 and close on 9 September 2021.

    $800 million is available to provide co-funding of up to one third of eligible project costs. This will be through grants between $20 million and $200 million to support large-scale projects that will transform the manufacturing sector by increasing collaboration, and building scale to enhance growth and competitiveness in the National Manufacturing Priority areas, including medical products and food and beverage.

    Please read today's member alert for more details, including eligibility criteria and how to apply.

  • 25 Jun 2021 11:37 AM | Anonymous member (Administrator)

    The TGA have published a reminder of important annual charges deadlines for sponsors, available here

    Sponsors are reminded that if a product is no longer supplied, the entry can be cancelled from the ARTG by this Wednesday, 30 June 2021 to prevent incurring 2021-22 annual charges.

    Products on the ARTG from 1 July 2021 will incur a 2021-22 annual charge (unless exempt).

    Information on how to request to cancel an entry/entries from the ARTG is available on the TGA website.

  • 18 Jun 2021 12:00 PM | Anonymous member (Administrator)

    The second reading of the Narcotic Drugs Amendment (medicinal cannabis) Bill 2021 ('the Bill') was passed in the Senate without amendment on June 17 2021.

    The Bill will introduce a single licence for the cultivation, production and manufacture of and research into medicinal cannabis. This aims to reduce the administrative burden on industry; however, it remains unclear whether these benefits will result in better processing times and reduced costs for patients.

    Read more here
  • 18 Jun 2021 9:41 AM | Anonymous member (Administrator)

    The public consultation on proposed changes to the Therapeutic Goods Advertising Code closes today, Friday 18 June 2021.

    CMA’s full submission in response to the Advertising Code consultation, including additional information, reasons and references, and the CMA/DSA submission on Endorsements and Testimonials is provided for your reference below:

     - CMA’s full submission is available here (79 pages)

     - CMA and DSA's submission on Endorsements and Testimonials is  available here (10 pages)

    Members are welcome to reference all or part of CMA's submission in your own submissions to the TGA public consultation and make additional comments, examples, or provide alternative suggestions.

    Your submissions to the Proposed improvements to the Therapeutic Goods Advertising Code consultation can be made via the Department of Health Consultation Hub

    Please note: the consultation Hub site is currently down. In the interim, please email advertising.consultation@tga.gov.au   

  • 15 Jun 2021 11:06 AM | Anonymous member (Administrator)

    The public consultation on proposed changed to the Therapeutic Goods Advertising Code closes this Friday, 18 June 2021.

    CMA have, in conjunction with our Regulatory Committee, developed a summary submission and recommendations in response to the Advertising Code consultation.

     - Please click to access your member-only Word or PDF copy of CMA’s summary response and recommendations, which includes comparative examples relating to the potential effect of the proposed changes to advertisements.

     - Please click here to also access a CMA document which compares existing and proposed 'health warnings' under the proposed changes to Schedule 1 of the Code (Table 1 and 2 of consultation paper).

    Members are welcome to reference all or part of CMA's submission in your own submissions to the public consultation. Members are also welcome to copy certain positions into your submissions and make additional comments, examples, or provide alternative suggestions from the viewpoint of your company.

    CMA's full submission on Friday will contain additional information, reasons and research references.

    Submissions can be made via the Department of Health Consultation Hub: Proposed improvements to the Therapeutic Goods Advertising Code

  • 04 Jun 2021 4:06 PM | Anonymous member (Administrator)

    The Therapeutic Goods Legislation Amendment (Fees) Regulations 2021 is now in effect.

    These regulations amend the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to increase the fees set out in those respective regulations by 1.05 per cent, for the financial year 2021-22.

    Please read today’s technical alert for more information on how the updated charges will be applied, including a summary of CMA’s response to the fees and charges consultation.

  • 24 May 2021 10:03 AM | Anonymous member (Administrator)

    FSANZ have released two calls for comment:

    1. Review of standard 2.9.1 Infant Formula- open 21 May 2021 to 7 July 2021

    2. A new way to measure fibre content in food- open 21 May 2021 to 22 June 2021

    Please read today’s technical alert for more information about each consultation and:

    - making submissions to the public consultations

    - providing feedback to CMA for a CMA industry submission.


  • 19 May 2021 11:48 AM | Anonymous member (Administrator)

    The TGA are holding an information session style online webinar on proposed changes to the Therapeutic Goods Advertising Code .

    The webinar will be held next Wednesday 26 May 2021, 12pm-2pm (AEST).

    The webinar will provide an overview of the key issues contained in the public consultation paper, including Q & A time throughout. The TGA have provided that the webinar will support stakeholders in considering the consultation paper.

    Register for the webinar here.

  • 18 May 2021 3:24 PM | Anonymous member (Administrator)

    Today's technical alert includes important information for members in relation to a recent safety review of titanium dioxide. In Australian therapeutic goods, titanium dioxide is used in listed and registered medicines. In listed medicines, when used as an excipient, titanium dioxide is approved for use only as a colour and only in medicines limited to oral and topical routes of administration. Today's alert includes:

     - Current information on EU activities

     - Effect this could have on TGA and FSANZ activities relating to medicines and foods containing the ingredient

     - Actions members should consider in relation to this information

     - History of the considerations since 2016, as provided by IADSA

    Please read the full alert for more details.

  • 12 May 2021 10:32 AM | Anonymous member (Administrator)

    Today's technical alert provides a reminder on important information for sponsors in relation to mandatory pharmacovigilance requirements and best practice TGA expectations. This technical alert was originally sent to members in November 2020 with a member alert, as well as a public link that can be accessed by non-members, describing the mandatory requirements.

    Included in both the public and member only alert is a reminder that notifying the TGA of a sponsor's pharmacovigilance contact person is a mandatory requirement under the Therapeutic goods Act 1989 please ensure that your company has an up-to-date pharmacovigilance contact person provided to the TGA and other mandatory requirements are met as outlined in this alert and on the TGA website.

    The member only alert, available here via member login, includes all of the information contained in the public alert below, in addition to other information tailored specifically to help members reduce regulatory burden and other member only information.

    The public alert is available for open distribution to all members of industry to ensure that all have access to timely reminders for minimum compliance requirements which help to uphold industry safety and quality. This public link can be shared.

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