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Tag Archives: Regulatory Services

Commercial Eyes Recruiting: Senior Consultant, Regulatory Services

  The Company Commercial Eyes is Australia’s leading Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & New Zealand.  We provide a full suite of services … Continue reading

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Commercial Eyes Recruiting: Senior Manager, Regulatory Services

  The Company Commercial Eyes is Australia’s foremost Pharmaceutical and Medical Device commercialisation consultancy offering pre and post market advice and support to local and international companies operating in Australia & NZ.  What we do – and the consistent excellence … 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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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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Commercial Eyes appoints Simon Higgins to head up new Commercialisation Services division

Commercial Eyes Pty. Ltd., one of Australia’s most successful health technology commercialisation companies, is pleased to announce the appointment of Simon Higgins to head up it’s new Commercialisation Services division. Simon joins Commercial Eyes with over 20 years’ experience in … 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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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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Transition to eCTD is gaining momentum in Australia

At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for … Continue reading

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