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MIL-OSI Australia: Supplier assessment, approval and qualification for listed and complementary medicines

By   /  January 17, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Exports, Health, KB, MIL OSI, Open Source Intel, Pacific Region, Republic of Korea, Technology, Trade  /  Comments Off on MIL-OSI Australia: Supplier assessment, approval and qualification for listed and complementary medicines

Source: Australian Department of Health – Therapeutic Goods Administration About this guidance This guidance is for manufacturers of listed and complementary medicines manufactured according to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP). This guidance is only applicable to manufacturers and sponsors of listed medicines and complementary medicines (including […]

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MIL-OSI Australia: TGA vs Industry time for GMP clearance applications

By   /  January 16, 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: TGA vs Industry time for GMP clearance applications

Source: Australian Department of Health – Therapeutic Goods Administration We receive a large number of GMP Clearance (CV) applications on an annual basis. Since the introduction of the redesigned application e-forms in September 2017, we are able to accurately capture the quality of applications received. This indicates that approximately ˜40% of all Compliance Verification (CV) […]

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MIL-OSI Australia: Process validation for listed and complementary medicines

By   /  January 16, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Exports, Health, KB, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region, Technology, Trade  /  Comments Off on MIL-OSI Australia: Process validation for listed and complementary medicines

Source: Australian Department of Health – Therapeutic Goods Administration About this guidance This guidance is for manufacturers of listed and complementary medicines manufactured according to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP). This guidance is only applicable to manufacturers and sponsors of listed medicines and complementary medicines (including […]

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MIL-OSI Australia: Ongoing stability testing for listed and complementary medicines

By   /  January 16, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Exports, Health, KB, Media Intelligence, MIL OSI, Open Source Intel, Pacific Region, Technology, Trade  /  Comments Off on MIL-OSI Australia: Ongoing stability testing for listed and complementary medicines

Source: Australian Department of Health – Therapeutic Goods Administration About this guidance This guidance is for manufacturers and sponsors of listed and complementary medicines manufactured according to the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP). This guidance is only applicable to manufacturers and sponsors of listed medicines and complementary […]

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MIL-OSI Australia: Medicinal gases guidance

By   /  January 15, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Exploration, Gas, Health, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Medicinal gases guidance

Source: Australian Department of Health – Therapeutic Goods Administration Version 2.0, January 2019 This guidance This guidance is for manufacturers of registered medicinal gases. It explains our interpretation and expectations for compliance with specific sections of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP). TGA has adopted the […]

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MIL-OSI Australia: Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

By   /  January 15, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, CTF, DJF, English, Germany, Health, Internet Communications Technology, KB, law, Legal, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Source: Australian Department of Health – Therapeutic Goods Administration Germany Black Ant 2000mg tablets pose a serious risk to your health and should not be taken. The Therapeutic Goods Administration (TGA) has tested a product labelled Germany Black Ant 2000mg tablets and found that: the tablets contain the undeclared substance sildenafil. Consumers are advised that […]

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MIL-OSI Australia: NAB Financial Planning bringing Beneficiary Nomination Forms matter to a close for clients

By   /  January 14, 2019  /  24-7, Aid, AM-NC, Announcements, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Banking, Banking and Finance, Business, CTF, DJF, English, Finance, KB, Media Intelligence, Media Release, MIL OSI, MLC, NAB, NAB Wealth, National Australia Bank, Open Source Intel, Pacific Region, Statement, Wealth  /  Comments Off on MIL-OSI Australia: NAB Financial Planning bringing Beneficiary Nomination Forms matter to a close for clients

Source: National Australia Bank NAB Financial Planning (NAB FP) has today confirmed it has proactively contacted all 2,520 clients identified as being impacted by falsely witnessed beneficiary nomination forms (BNF), helping to bring the matter to a close. Beneficiary nomination forms set out who an individual wants to receive their superannuation funds in the event […]

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MIL-OSI Australia: Submissions received: Benzocaine: proposed advisory statements for medicines

By   /  January 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: Submissions received: Benzocaine: proposed advisory statements for medicines

Source: Australian Department of Health – Therapeutic Goods Administration The TGA would like to thank the respondent who submitted written comments in response to the consultation: benzocaine: proposed advisory statements for medicines. Submissions received One submission was received, with consent provided for publication on the TGA website: The respondent supported the new warning statement. Final […]

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MIL-OSI Australia: Funding for Kakadu a major win for tourism in the Top End

By   /  January 13, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Business, Commerce, CTF, DJF, Economy, Employment, English, Investment, KB, Media Intelligence, MIL OSI, Minister for Trade and Investment, Minister for Trade and Investment Steven Ciobo, Oceania, Open Source Intel, Pacific Region, Tasmania, Tourism, Trade  /  Comments Off on MIL-OSI Australia: Funding for Kakadu a major win for tourism in the Top End

Source: Minister for Trade Tourism and Investment Kakadu National Park is set for a $216 million upgrade designed to lure more visitors to the iconic Australian landmark and drive more investment and jobs in the Territory. As part of the plan announced today by the Liberal-National Government, the neighbouring township of Jabiru will also receive […]

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MIL-OSI Australia: Consultation: Proposed amendments to the Poisons Standard – ACCS meeting, March 2019

By   /  January 10, 2019  /  24-7, AM-NC, Asia Pacific, Asia Pacific Region, Australia, Australian Economy, Australian Federal Government, Business, Commerce, CTF, Culture, DJF, English, Health, Internet Communications Technology, KB, MIL OSI, Open Source Intel, Pacific Region  /  Comments Off on MIL-OSI Australia: Consultation: Proposed amendments to the Poisons Standard – ACCS meeting, March 2019

Source: Australian Department of Health – Therapeutic Goods Administration This consultation closes on 8 February 2019. MCPB has been added to the proposals to amend the Poisons Standard, referred by the delegate of the Secretary to the Department of Health, to the March 2019 meeting of the Advisory Committees on Chemicals Scheduling (ACCS) as a […]

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