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137 results

  • Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR

    Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to utilise TGA’s web publication service to provide market notifications to health care providers and/or end users as a result of your devices transitioning from the EU MDD to the EU MDR. ... More
    Opened 1 December 2022

  • Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR

    This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take as a result of changes to conformity assessment documents relevant to your medical devices as a result of the implementation of the European Union Medical Device Regulations (EU MDR). ... More
    Opened 1 December 2022

  • Online Survey: Consent to import, supply or export a medical device that does not comply with the Essential Principles

    From 1 December 2021, the application for consent to import, supply, or export a medical device that does not comply with the Essential Principles has moved to the TGA Business Services (TBS) portal. The new form will provide stakeholders with a more efficient way of submitting an application to the TGA. The purpose of this survey is to seek your feedback on the new application form. More
    Closed 1 December 2022

  • International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names

    The Therapeutic Goods Administration (TGA) is seeking views on medicine ingredient names that must be displayed as both the old and new ingredient name ('dual labelled') on labels and Product Information (PI) and Consumer Medicine Information (CMI) documents until 30 April 2023 as part of International harmonisation of ingredient names (IHIN) . We are seeking feedback on: whether health professionals, consumers and health systems are ready for dual labelling to end... More
    Closed 19 December 2022

  • Proposed reforms to the regulation of nicotine vaping products

    The Therapeutic Goods Administration (TGA) is seeking public comment on potential reforms to the regulation of nicotine vaping products (NVPs) in Australia. The potential reforms are aimed at preventing children and adolescents from accessing NVPs, while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription. We are seeking public comment on whether you support potential reforms in 4 main areas:... More
    Closed 16 January 2023

  • ODC Monitoring and Compliance Section Licence Holder Engagement Survey

    The Office of Drug Control Monitoring and Compliance Section is seeking feedback on its operational performance and engagement with Medicinal Cannabis Licence holders. The medicinal cannabis industry’s feedback will help the Monitoring and Compliance Section meet stakeholders expectations in accordance with best practice regulation. More
    Closed 27 January 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, MARCH 2023

    Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the March 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 3 February 2023. ... More
    Closed 3 February 2023

  • Medicinal Cannabis Program Fees and Charges Review

    On 24 December 2021 several changes to the Narcotic Drugs Act 1967 came into effect, including the introduction of a single licence model for cultivation, production and/or manufacture activities. At this time the Office of Drug Control (ODC) also implemented simpler permit processes and administrative reforms to reduce regulatory burden. Following these reforms, the existing cost model was also reviewed, including the level at which fees and charges are set. In doing so it... More
    Closed 10 February 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2022

    Interim decisions regarding substances discussed at the expert advisory meetings. Please note that this consultation is for substances other than paracetamol. If you wish to comment the proposed interim decision in relation to paracetamol please see the link below: Consultation for interim decision for paracetamol This consultation is for interim decisions made in relation to the other substances that were discussed at the November 2022 meetings of the Advisory... More
    Closed 3 March 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS #40 NOVEMBER 2022 (paracetamol)

    Interim decisions regarding substances discussed at the expert advisory meetings. Please note that this consultation is for the interim decision in relation to paracetamol only . If you wish to comment on the interim decisions for other substances discussed at the November 2022 meetings, please see the link below: Consultation for November 2022 (other substances) This consultation is for the interim decision in relation to paracetamol which was discussed at the ... More
    Closed 3 March 2023

  • Seeking feedback on improvements to the recalls process

    The Therapeutic Goods Administration (TGA) is seeking feedback on improvements to the therapeutic goods recalls process. In Australia, recalls should be done in accordance with the procedures in our guidance document - the Uniform Recall Procedure for Therapeutic Goods (URPTG) . Performing recalls in accordance with standardised and agreed procedures is important to effectively respond to issues with therapeutic goods which may pose a risk to public health and... More
    Closed 13 March 2023

  • Public Consultation - TGA Fees and Charges proposal 2023-24

    The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA's proposed fees and charges for the 2023-24 financial year. Specifically, we are seeking feedback on the potential impact of the proposed fees and charges prior to seeking approval from the Government for any changes. The TGA within the Department of Health and Aged Care is responsible for regulating... More
    Closed 21 March 2023

  • Allied health professionals point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Medical devices can include assistive technology, whether... More
    Closed 14 May 2023

  • Medical device manufacturing hubs at the point-of-care survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Over the past two decades, rapid advances in computing... More
    Closed 14 May 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS, JUNE 2023

    Proposed amendments to the Poisons Standard referred to advisory committees We are consulting on applications and delegate-initiated proposals to amend the Poisons Standard. The proposed amendments and any submissions received will be considered at the June 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ACMS and Advisory Committee on Chemicals Scheduling (ACCS) in joint session (Joint ACMS-ACCS). ... More
    Closed 17 May 2023

  • Dental and oral health professionals point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Over the past two decades, rapid advances in computing... More
    Closed 17 May 2023

  • Hospital and healthcare facility point-of-care manufacturing survey

    Prior to February 2021, most medical devices that were designed and manufactured to suit an individual patient/client were known as “custom-made” medical devices. These kinds of devices were not required to have TGA approval or to be included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported, or supplied (although they were subject to other regulatory obligations). Over the past two decades, rapid advances in computing... More
    Closed 17 May 2023

  • Clarification and updates to the regulation of sunscreens

    The Therapeutic Goods Administration (TGA) is seeking public comment on potential clarification and updates to the regulation of sunscreens. The potential regulatory clarification and updates include: Adoption of the Australian/New Zealand Standard Sunscreen products - Evaluation and classification AS/NZS 2604:2021 Amd 1:2022 (the 2021 Sunscreen Standard) which specifies the current testing and labelling requirements for sunscreens. Removal of the... More
    Closed 31 May 2023

  • Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification

    From 1 July 2023, sponsors may apply for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification. Background In accordance with the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 , certain categories of medical devices are required to be reclassified so they align, wherever possible with the changes introduced in European Union (EU) medical devices framework. Transitional... More
    Opened 1 July 2023

  • Application to amend the Poisons Standard

    This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details. If you are still having difficulties in completing the form, you can contact the Scheduling Secretariat via email. All information provided must be in... More
    Closed 14 July 2023

  • Consultation - Review of regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin

    The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program. The TGA periodically reviews requirements for medical devices to ensure they continue to be... More
    Closed 28 July 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS MARCH 2023

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to the other substances that were discussed at the March 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can... More
    Closed 10 August 2023

  • Public consultation on interim decision to amend the Poisons Standard - Joint ACMS-ACCS June 2023 - LEAD

    Interim decision regarding lead following the discussions at the Joint meeting of ACMS-ACCS held in June 2023. This consultation is the interim decision for LEAD (in anti-fouling paints) that was discussed at the June 2023 Joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decision in relation to lead may differ from the initial proposal. Please read through the proposed... More
    Closed 1 September 2023

  • MDSAP survey

    The TGA is seeking feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP). By completing this survey, your response will help us to better understand any concerns with the operation of the program. Sponsors may reach out to applicable Manufacturers for help answering specific questions on audit activities if necessary, although the intent of the survey is to better understand the Sponsor interactions during MDSAP audits. The following survey should... More
    Closed 1 September 2023

  • Public consultation: Proposed application audit framework for medical devices

    The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program. The TGA is responsible for regulating the import, export, and supply of medical devices, including... More
    Closed 4 September 2023

  • Proposed New Guidelines for the Quality of Listed Probiotic Medicines

    The Therapeutic Goods Administration (TGA) is seeking feedback on the proposed new ‘Guidelines for the Quality of Listed Probiotic Medicines (the Guidelines)’. Probiotics are defined as live microorganisms that when administered in adequate amounts, are proposed to confer a health benefit on the host. The quality requirements for listed probiotic medicines are complex to piece together. The purpose of these Guidelines is to help sponsors and manufacturers meet the... More
    Closed 10 September 2023

  • Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2023-24

    The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues: Curcuma species and curcumin and the risk of liver injury Green tea extract and the risk of liver injury Safe levels of benzophenone Clarification of the requirements for soy phosphatidylserine-enriched... More
    Closed 14 September 2023

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2023

    Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the NOVEMBER 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 29 September... More
    Closed 29 September 2023

  • ODC Monitoring and Compliance Section Cannabis Waste Management Survey

    The Office of Drug Control Monitoring and Compliance Section (MaCS) are seeking clarification of the nature and effectiveness of the various waste management and destruction processes employed by licence holders. This survey will inform ODC decision makers on effective waste management and destruction measures being used. The survey will be used by the ODC to develop guidance and educational materials for industry and enable the ODC to better support licence holders. More
    Closed 30 September 2023

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2023

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to the other substances that were discussed at the JUNE 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint meeting of the ACMS and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the... More
    Closed 2 November 2023
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