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Category Archives: TGA

Relating to the Australian Therapeutic Goods Administration

Coronavirus (COVID-19): Information on medicines and medical devices supply in Australia

The Therapeutic Goods Administration (TGA) has consolidated all the COVID‑19 information on their website to assist manufacturers and suppliers with accessing the latest information about the special regulatory requirements for the supply of medicines and devices (including exemptions) in Australia … Continue reading

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Improved Consumer Medicine Information template

The TGA have now released implementation dates for the updated Consumer Medicine Information (CMI) template that was developed throughout 2019 to reduce complexity and improve readability. Newly registered medicines must use the new template from 1 January 2021, while previously … Continue reading

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Hand sanitiser – What do you need to know to supply in Australia?

The COVID-19 pandemic has seen the TGA rapidly changing the regulatory landscape for in-demand products that can help reduce the spread of the virus. Given all the changes taking place, it can be difficult to ascertain exactly how product categories … Continue reading

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Brexit – What’s the impact on medicines and medical devices supplied in Australia?

  The long-awaited Brexit is underway with the UK exiting the EU on 31 January 2020 A transition period is now in effect until the end of 2020 with the possibility for extension. Its status quo for Australia during the transition … Continue reading

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TGO 91 and TGO 92 – are your labels ready?

Following the 4-year transition period, the medicine labelling Therapeutic Goods Orders (TGOs), TGO 91 for prescription medicines and TGO 92 for non-prescription medicines, will become mandatory on 1 September 2020. Medicines that are released for supply on or after 1 September … Continue reading

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No CE mark? No problem.

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading

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Are you ready for the mandatory transition to eCTD for prescription medicines?

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new … Continue reading

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Making the most of complementary medicines reforms

In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms.    One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications.  All … Continue reading

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What is Happening with the Provisional Approval Pathway?

We’ve come a long way When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines. A provisional approval pathway would allow … Continue reading

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New ‘SmPC’ Format for the Australian Product Information

The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients.  The new form will be implemented over a … Continue reading

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