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MIL-OSI Australia: Electronic Instructions for Use – eIFU

By   /  August 15, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Canada, English, Health, Internet Communications Technology, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region, Resource Exploitation, Resource Exploration, Technology, United States of America  /  Comments Off on MIL-OSI Australia: Electronic Instructions for Use – eIFU

Source: Australian Department of Health – Therapeutic Goods Administration The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets regulations, and thus indicate how to comply. This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If […]

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MIL-OSI Australia: Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

By   /  August 15, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, English, Health, law, Legal, MIL OSI, Open Source Intel, Pacific Region, Trade  /  Comments Off on MIL-OSI Australia: Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

Source: Australian Department of Health – Therapeutic Goods Administration On the evening of 12 August 2018, the documentary Vitamania premiered in Australia. The documentary explores the role of vitamins and vitamin purchases around the world. To provide context for the film, we describe how the Therapeutic Goods Administration (TGA) regulates vitamins in Australia. The TGA […]

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MIL-OSI Australia: WTO Dispute against Canada

By   /  August 15, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Canada, Economy, English, Exports, Investment, Media Intelligence, MIL OSI, Minister for Trade and Investment, Minister for Trade and Investment Steven Ciobo, NATO, Open Source Intel, Pacific Region, Tourism, Trade, World Trade Organisation  /  Comments Off on MIL-OSI Australia: WTO Dispute against Canada

Source: Minister for Trade Tourism and Investment Steven Ciobo Media release 15 August 2018 The Turnbull Government is taking the next step in its World Trade Organization (WTO) dispute against Canada’s discriminatory measures affecting Australian wine. In January Australia launched formal WTO consultations against Canada in the hope that it would remove its restrictions on […]

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MIL-OSI Australia: IMDRF consultation: Principles of labelling for medical devices and IVD medical devices

By   /  August 13, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, English, Health, MIL OSI, Open Source Intel, Pacific Region, Technology  /  Comments Off on MIL-OSI Australia: IMDRF consultation: Principles of labelling for medical devices and IVD medical devices

Source: Australian Department of Health – Therapeutic Goods Administration This consultation closes on 12 September 2018. The International Medical Device Regulators Forum (IMDRF) working group on Good Regulatory Review Practices seeks to promote a globally harmonised approach in premarket review processes. Their current Work Item is to develop a common set of competency, training, and […]

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MIL-OSI Australia: IMDRF consultation: Terminologies for categorised adverse event reporting

By   /  August 13, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: IMDRF consultation: Terminologies for categorised adverse event reporting

Source: Australian Department of Health – Therapeutic Goods Administration This consultation closes on 12 October 2018. The International Medical Device Regulators Forum (IMDRF) working group on Adverse Event Terminology seeks to improve, harmonise and, where necessary, expand the terminology and systems being used to code information relating to medical device adverse events. Their current work […]

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MIL-OSI Australia: IMDRF consultation: Unique Device Identification system

By   /  August 13, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: IMDRF consultation: Unique Device Identification system

Source: Australian Department of Health – Therapeutic Goods Administration This consultation closes on 12 October 2018. The International Medical Device Regulators Forum (IMDRF) working group on a Unique Device Identification (UDI) system seeks to promote a globally harmonised approach to the application of a UDI system. This work is intended to contribute to the implementation […]

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MIL-OSI Australia: Medical devices post-market vigilance – statistics for 2017

By   /  August 10, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Capital Territory, Australian Economy, Australian Federal Government, Education, English, Environment, Exploration, Exports, Gas, Health, Media Intelligence, MIL OSI, New South Wales, Open Source Intel, Pacific Region, Sydney, Technology, Trade  /  Comments Off on MIL-OSI Australia: Medical devices post-market vigilance – statistics for 2017

Source: Australian Department of Health – Therapeutic Goods Administration Foreword The Therapeutic Goods Administration (TGA) is responsible for regulating medical devices in Australia, including monitoring the ongoing safety, performance and quality of devices once they have been included on the Australian Register of Therapeutic Goods (ARTG). This report from the TGA’s Medical Devices Branch includes […]

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MIL-OSI Australia: Medicines and vaccines post-market vigilance – statistics for 2017

By   /  August 10, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, English, Exports, Health, MIL OSI, Open Source Intel, Pacific Region, Trade, United Kingdom, United States of America  /  Comments Off on MIL-OSI Australia: Medicines and vaccines post-market vigilance – statistics for 2017

Source: Australian Department of Health – Therapeutic Goods Administration Foreword The Therapeutic Goods Administration (TGA) is responsible for regulating medicines, vaccines and biologicals, including monitoring the ongoing safety, quality and efficacy of these products once they have been included on the Australian Register of Therapeutic Goods (ARTG) through product vigilance activities. On an annual basis, […]

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MIL-OSI Australia: Consultation: Proposed therapeutic goods advertising code guidance

By   /  August 9, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Capital Territory, Australian Economy, Australian Federal Government, Business, Commerce, Education, English, Health, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Consultation: Proposed therapeutic goods advertising code guidance

Source: Australian Department of Health – Therapeutic Goods Administration This consultation closes on 4 October 2018. Many stakeholders who made submissions to the April 2018 consultation on the draft Therapeutic Goods Advertising Code 2018 (the Code) called for further consultation on the Code guidelines. Accordingly, the TGA is seeking input from interested parties on the […]

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MIL-OSI Australia: Valsartan

By   /  August 8, 2018  /  24-7, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, English, Health, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Valsartan

Source: Australian Department of Health – Therapeutic Goods Administration Safety advisory – products in Australia not affected by overseas recalls Consumers and health professionals are advised that valsartan-containing medicines, used to treat high blood pressure (also known as hypertension), are not currently subject to any recall action in Australia. The TGA is aware of overseas […]

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