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Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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- Advanced therapies (2)
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265 result(s) found, displaying 151 to 175
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GuidanceThis guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know.
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GuidanceThis guidance is to assist health practitioners understand their requirements when prescribing ‘unapproved’ therapeutic goods for an individual patient using the Special Access Scheme (SAS).
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GuidanceThis guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.
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Accessing unapproved biologicals that are not on the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG). -
GuidanceGuidance on how we make use of assessments from comparable overseas regulators (CORs).
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).
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GuidanceGuidance for medical practitioners, Human Research Ethics Committees, specialist colleges and sponsors of 'unapproved' therapeutic goods.
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GuidanceGuidance on changing information in the ARTG for listed or assessed listed medicines.
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GuidanceGuidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.
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GuidanceGuidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.
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GuidanceGuidance on medical device application processing timeframes.
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GuidanceThis guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.
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GuidanceGuidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.
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GuidanceGuidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance and other resources for sponsors about mandatory reporting of medicine shortages in Australia.
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GuidanceGuidance on our expectations concerning clinical performance requirements and risk mitigations for in vitro diagnostic medical devices intended to be used as self-tests for chlamydia, gonorrhoea and syphilis.
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GuidanceGuidance to understand how we interpret regulations and how manufacturers can comply with them.
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GuidanceGuidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.
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GuidanceThis guidance helps providers of digital mental health services or products to understand their regulatory obligations.
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
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GuidanceThis guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.