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MIL-OSI Australia: Curam Duo 400/57

By   /  May 22, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Health, KB, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Curam Duo 400/57

Source: Australian Department of Health – Therapeutic Goods Administration Recall – potential for reduced effectiveness Consumers and health professionals are advised that Sandoz Australia, in consultation with the TGA, is recalling two batches of Curam Duo 400/57 (batch numbers JC5418 and JC5419, both with expiry date July 2021). Curam Duo is a prescription medicine that […]

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MIL-OSI Australia: TGA actions after review into urogynaecological surgical mesh implants

By   /  May 17, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Health, KB, law, Legal, MIL OSI, Open Source Intel, Pacific Region, Technology  /  Comments Off on MIL-OSI Australia: TGA actions after review into urogynaecological surgical mesh implants

Source: Australian Department of Health – Therapeutic Goods Administration Update – Boston Scientific mesh recall This advice supplements previous advice from the 22 December 2017 statement. Background In August 2017, supply of the Pinnacle LITE Pelvic Floor Repair Kit was discontinued from the Australian market. In December 2017, the indications for use of the Xenform […]

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MIL-OSI Australia: TGA continues action against Peptide Clinics Australia for alleged advertising breaches

By   /  May 17, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Business, Commerce, CTF, DJF, English, Health, Justice, KB, law, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: TGA continues action against Peptide Clinics Australia for alleged advertising breaches

Source: Australian Department of Health – Therapeutic Goods Administration The Federal Court has granted leave to the Secretary of the Department of Health to continue court proceedings against Peptide Clinics Australia following the company’s liquidation in March this year. The Secretary commenced proceedings against Peptide Clinics Australia (Peptide Clinics Pty Ltd) in November last year […]

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MIL-OSI Australia: Webinar recording: SME Assist – Permitted indications for listed medicines, March 2019

By   /  May 16, 2019  /  24-7, Aid, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Business, Commerce, CTF, DJF, English, Exploration, Gas, Health, KB, Media Intelligence, MIL OSI, New South Wales, Open Source Intel, Pacific Region, Technology, Trade  /  Comments Off on MIL-OSI Australia: Webinar recording: SME Assist – Permitted indications for listed medicines, March 2019

Source: Australian Department of Health – Therapeutic Goods Administration Slide 1 Rachel: Text Dr Adam Cook is here to my right. He’s worked nationally and internationally for several years as a biomedical research scientist and previously at the TGA as a senior toxicologist, and he’s now the director of the Listing compliance section within the […]

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MIL-OSI Australia: Webinar recording: SME Assist – Permitted indications for listed medicines

By   /  May 16, 2019  /  24-7, Aid, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Business, Commerce, CTF, DJF, English, Exploration, Gas, Health, KB, Media Intelligence, MIL OSI, New South Wales, Open Source Intel, Pacific Region, Technology, Trade  /  Comments Off on MIL-OSI Australia: Webinar recording: SME Assist – Permitted indications for listed medicines

Source: Australian Department of Health – Therapeutic Goods Administration Slide 1 Rachel: Text Dr Adam Cook is here to my right. He’s worked nationally and internationally for several years as a biomedical research scientist and previously at the TGA as a senior toxicologist, and he’s now the director of the Listing compliance section within the […]

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MIL-OSI Australia: Medical device annual reporting – Sponsor obligations

By   /  May 15, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Health, Justice, KB, law, MIL OSI, Open Source Intel, Pacific Region, Technology  /  Comments Off on MIL-OSI Australia: Medical device annual reporting – Sponsor obligations

Source: Australian Department of Health – Therapeutic Goods Administration All sponsors of medical devices included on the Australian Register of Therapeutic Goods (ARTG) must comply with certain automatic conditions of inclusion. For sponsors of Class IIb (implantable) and Class III devices, AIMD or Class 4 IVD, these obligations include submitting annual reports to the TGA […]

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MIL-OSI Australia: Delegate-only final decisions and reasons: Agricultural and veterinary chemicals

By   /  May 14, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Delegate-only final decisions and reasons: Agricultural and veterinary chemicals

Source: Australian Department of Health – Therapeutic Goods Administration Scheduling medicines and poisons Subdivision 3D.3 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out the procedure to be followed where the Secretary receives an application under section 52EAA of the Therapeutic Goods Act 1989 (the Act) to amend the current Poisons Standard and decides […]

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MIL-OSI Australia: Vaccines overview

By   /  May 14, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Vaccines overview

Source: Australian Department of Health – Therapeutic Goods Administration The Therapeutic Goods Administration (TGA) is responsible for assessing vaccines and other medicines before they can be used in Australia. We only register a vaccine for use in Australia if its benefits are much greater than its risks. What is a vaccine? Vaccines are medicines that […]

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MIL-OSI Australia: Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD)

By   /  May 6, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Webinar: An update on the consultation for the Regulation of Software, including Software as a Medical Device (SaMD)

Source: Australian Department of Health – Therapeutic Goods Administration The TGA recently consulted on proposals to amend the regulation of software, including Software as a Medical Device (SaMD). This webinar will provide an overview of the consultation, the reason for the proposed changes and a summary of the feedback received. Background The TGA regulates software […]

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MIL-OSI Australia: Webinar: How to apply to list a medicine using permitted indications

By   /  May 1, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Business, Commerce, CTF, DJF, English, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Webinar: How to apply to list a medicine using permitted indications

Source: Australian Department of Health – Therapeutic Goods Administration Overview This webinar will provide information for sponsors of existing listing medicines to transition to permitted indications. The webinar includes a tutorial on how to navigate the TGA eBusiness Services portal and explains how to make a variation to an existing good to change from specific […]

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